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Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: We are seeking a proactive, resourceful, and detail-oriented Executive Assistant to join our team on a 6-month contract. The successful candidate will play a key role in supporting day-to-day CEO operations, with a strong focus on calendar management, event coordination, and general office support. This is a dynamic and highly visible role where you’ll be a key partner to executives, ensuring seamless day-to-day operations and contributing to broader strategic initiatives. Contract Duration: 6-9 Months beginning November 2025. Potential for full-time employment at the end of the contract based on business need. Responsibilities: • Deliver comprehensive administrative assistance to the CEO, including calendar and inbox management, meeting coordination, document creation, and complex domestic and global travel arrangements., • Serve as a liaison between the CEO and executive leadership team, ensuring alignment and streamlined communication., • Manage the CEO’s professional and personal calendar and provide event support, liaising with family members as needed., • Filter and prioritize incoming requests, communications, and documents for the CEO with the utmost discretion., • Plan and execute internal and external meetings, leadership offsites, and industry events, including communications, logistical components and vendor coordination., • Serve as a primary point of contact for internal and external stakeholders, ensuring timely and professional responses., • Develop agendas for key meetings, capture meeting notes, ensure distribution and follow-through on action items., • Handle ad-hoc administrative tasks and other duties as assigned., • Flexibility to be on site in Brooklyn, based on businesses needs and the schedule of the CEO. Requirements • 3-5 years of administrative experience as an executive assistant or other support role., • Strong organizational and time management skills., • Excellent written and verbal communication., • Advanced in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint), • Outstanding ability to execute reliably and prioritize time and tasks., • Resilience to navigate competing priorities and constant change., • Incredibly proactive and able to work efficiently with little direction., • Resourceful and agile in day-to-day work., • A positive attitude and willingness to learn., • Paid Vacation, Sick, & Holidays, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage, • Company Paid Life and Short-Term Disability Coverage, • Work/Life Employee Assistance Program, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Monthly MetroCard Reimbursement, • The compensation for this role is $80-100k per year.

Job DescriptionManufacturing Associate II Allendale, NJ Lynkx Staffing specializes in placing Biotechnology, Pharmaceutical, Medical Devices, IT & Human Resources professionals in New Jersey. Under the supervision of the Associate Manager, the Manufacturing Associate II processes, cultures, cryopreserves and otherwise manipulates cell products using aseptic techniques, according to written Standard Operating procedures, in accordance to facility GLP, GTP and GMP practices. Facility and personnel specific responsibilities will be regulated by company's policies or client procedures being performed at each Cellular Production Facility. The ideal candidate must have a collaborative and inquisitive nature, must possess excellent organizational and verbal and written communication skills and be flexible in their working hours. • Performs any and all required processing and manipulation required to produce and assess safe and efficacious products, • Proficiently functions within an ISO Class 7 and 6 clean room environments, ensuring personal and product safety, • Consistently produce a high level of documentation accuracy and clarity, • Performs cryopreservation of products using DMSO base solutions and controlled-rate freezers, • Proficiently operate and maintain equipment according to designed procedures. Assigned responsibilities could include but is not limited to COBE 2991 cell washer, Clinimacs cell separator, Elultra cell separator, controlled- rate freezers, temperature monitoring systems, alarm systems, biological safety cabinets, CO2 incubators, liquid nitrogen freezers, microscopes, pipets, wave bioreactors, refrigerators, ultra- cold freezers, water baths, tube sealers, dry shippers, centrifuges, sterile connection devices, • Manipulate products according to established standard operating procedures and batch records such as enrichments, depletions, cell expansions, or volume reductions to achieve predetermined endpoints, • Participating in clinical trial support and studies, may include but not limited to sample preparation, sample shipping, media and reagent preparation., • Thawing and/or washing cryopreserved hematopoietic cell products either at the Clinical Site or in the facility as specified by standard operating procedures, • Performing facility and equipment duties such as periodic maintenance, preventive maintenance, for applicable methods and equipment, reporting facility and equipment problems to Assistance Manager, trouble-shooting facility and equipment problems as specified in standard operating procedures, • Notifying Management of any deviation that may occur during processing or during equipment maintenance., • Applies knowledge of processing principles and techniques to make good judgement and appropriate decisions, • Performs investigations for deviations and complete deviations and CAPA’s (Corrective and Preventive Actions) in a timely manner, • Supports technology transfers into GMP manufacturing operations, • Participate in the on-call programREQUIREMENTS, • BA/BS or Associate's Degree in a biologics or related field preferred, • 2-4 + years of applicable experience in a clinical laboratory, hematology, blood banking, immunology or cGMP manufacturing, • Current Medical Technologist license or equivalent is a plus, • Aseptic/cell processing and clean room experience preferred, • Demonstrates tact and courtesy in dealing with others, • Strong work ethic, methodical approach to new challenges, • GLP and GMP experience a plus, • Must be able to work independently and with minimal supervision, • Able to work in fast paced environment at times under pressure and with tight deadlines, • Excellent organizational skills and attention to detail, • Good verbal and written communication skills, • Strong team-oriented interpersonal skills are essential, • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work a flexible schedule that may include nights, weekends and/or holidays, • Training Required; GMP, Gowning training/qualification, Aseptic process qualification (personal media fill), • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the companyWorking EnvironmentMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogenMust have the ability to work in the cleanroom environment for extended period of timeMust have the ability to work with specialized equipmentMust be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Inizio Engage is building a nationwide team of field based Pharmaceutical Field Sales Representatives that will be led by District Managers. The District Manager is an excellent role to continue to develop your management skills in the healthcare and pharmaceutical industries. The team will be dedicated to providing services to Inizio’s client, Pfizer. We are seeking performance-driven, competitive, highly entrepreneurial, and analytical Leaders to recruit and lead these representatives. This is a highly innovative role requiring you to lead by example to drive district performance, think outside of the box and continually challenge your team to go the extra mile. This is your opportunity to join Inizio Engage, a top biotechnology company! What’s in it for you? * Competitive compensation * Excellent Benefits – accrued time off, medical, dental, vision, 401k, disability & life insurance, paid maternity and paternity leave benefits, employee discounts/promotions * Employee discounts & exclusive promotions * Recognition programs, contests, and company-wide awards * Exceptional, collaborative culture * Best Places to Work in BioPharma (2022, 2023, & 2024) * Certified Great Place to Work (2022, 2023, 2025) What will you be doing? * Recruit, hire and manage a high performing team * Create and drive district strategy and short-term tactics to achieve business goals in a timely manner * Work in the field with representatives to coach and counsel on improvement of their skills, product knowledge, and capabilities needed for successful representative development and maximum goal achievement * Monitor data analytics information (trends, activity) continuously to ensure full utilization of available resources and tools for maximum impact on prescribing providers while constantly looking for opportunities to improve * Drive call plan adherence and execution * Ensure that the given geography meets or exceeds all targets and goals * Set a positive tone and high standard for the district team in terms of work ethic, culture, expectations, business ethics * Assess competitive threats and take appropriate action * Aid in design of business plans, employee development plans, monthly reports as required * Organize employee training, conferences, and district meetings * Work with representatives to share success stories and adapt best practices with the district and across the nation * Communicate with key leadership regularly (written and verbal) to update on project performance, gain feedback, build relationships, and network to identify future opportunities What do you need for this position? * Bachelor’s Degree from an accredited College or University * Ability to influence team member activities * 5 years of management experience within the Pharmaceutical, Biotechnology or Healthcare Industry is preferred with proven ability to develop and motivate others, lead through change, and deliver on set objectives. * Ability to recruit, retain, and develop a high-quality team * A deep understanding of the pharmaceutical and healthcare industries * Lead a team and reinforce strong account management skills - i.e., the ability to work an account to include health systems/urgent care centers/pharmacies to gain access and support pull through * Product launch experience preferred * Must consistently demonstrate sound judgment and strategic decision-making abilities * Strong organizational and analytical skills are also required and ability to analyze and draw appropriate conclusions using call reporting data * Professional, proactive demeanor * Ability to interpret and utilize business data to drive positive business results * Strong interpersonal skills and ability to build business relationships * Results-driven with exceptional attention-to-detail and knowledge around metrics * Overnight travel may be required (depending on geographical location) * Valid Driver’s License * Computer/iPad proficient About Inizio Engage Inizio Engage is a strategic, commercial, and creative engagement partner that specializes in healthcare. Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people and providers to improve treatment outcomes. Our mission is to partner with our clients, improving lives by helping healthcare professionals and patients get the medicines, knowledge and support they need. We believe in our values: We empower everyone/We rise to the challenge/We work as one/We ask what if/We do the right thing, and we will ask you how your personal values align to them. To learn more about Inizio Engage, visit us at: ___ Inizio Engage is proud to be an equal opportunity employer. Individuals seeking employment at Inizio are considered without regards to age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition (including pregnancy, childbirth, or related medical conditions), mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. Further, pursuant to applicable local ordinances, Inizio will consider for employment qualified applicants with arrest and conviction records. Inizio Engage is an equal opportunity employer M/F/V/D. We appreciate your interest in our company, however, only qualified candidates will be considered.

Inizio Engage has a long-standing partnership with Genentech, a leading Biotechnology company, across Commercial, Patient Solutions and Medical Affairs businesses. We are going into season eight promoting XOFLUZA, an innovative, one-dose flu antiviral medicine. We are seeking performance-driven, proven, ambitious, and competitive sales professionals who are willing to put forth discretionary effort to go the extra mile. This is a highly innovative role, which requires you to drive use of XOFLUZA in your assigned territory through brand messaging, focused call plan execution, utilization of product materials, and access support. This is your opportunity to join Inizio Engage, represent a top biotechnology company, promoting XOFLUZA. What’s in it for you? • Seasonal opportunity – 4 month seasonal opportunity, • Competitive compensation, • Excellent Benefits – accrued time off, medical, dental, vision, 401k, disability & life insurance, paid maternity and paternity leave benefits, employee discounts/promotions, • Employee discounts & exclusive promotions, • Recognition programs, contests, and company-wide awards, • Exceptional, collaborative culture, • Best Places to Work in BioPharma (2022, 2023, & 2024), • Certified Great Place to Work (2022, 2023, 2025) What will you be doing? • Establish, maintain, and develop strong relationships with customers in HCP offices, urgent care facilities and pharmacies both in person and virtually, • Exhibit excellent sales and relationship-building skills to directly impact the utilization of XOFLUZA, • Apply discretionary and entrepreneurial effort to ensure your maximizing your territory’s potential, • Deliver appropriate and approved information and relevant messaging to target accounts, • Achieve sales and call activity targets as set by the company, • Complete administrative duties as required What do you need for this position? • Bachelor’s degree required or equivalent work related experience, • B2B or B2C sales experience, • A proven track record of driving results in primary care sales, hospitality or equivalent sales/industry experience is required, • Strong account management skills - i.e., the ability to work an account to include health systems/urgent care centers/pharmacies to gain access and support pull through, • Ownership mentality with a strong sense of urgency and taking initiative and the ability to anticipate possible obstacles and proactively problem solve, • Ability/willingness to travel by driving an assigned territory/region, • Ability/willingness to travel by plane (including overnight stay) to cover another territory when necessary, • Competitive trailblazing mentality, • Confidence in handling rejection, • Persistence and disciplined self-management, • Able to handle a fast pace and high volume of face-to-face interactions and effectively adhere to a focused call plan, • Business Acumen, • Thorough familiarity with pharmacies and proven track record of influencing stocking, • Strong interpersonal, teamwork/collaboration and relationship-building skills, • Excellent communication skills and ability to build rapport quickly face to face and virtually, • Capable to initiate and leverage contacts to build appropriate new business referrals, • Driven with a desire to consistently increase your earnings, • Detail oriented and able to problem solve, • Valid driver’s license and clean driving record, • Computer/iPad proficient, • Strong understanding and ability to comfortably navigate Microsoft suite, specifically excel About Inizio Engage Inizio Engage is a strategic, commercial, and creative engagement partner that specializes in healthcare. Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people and providers to improve treatment outcomes. Our mission is to partner with our clients, improving lives by helping healthcare professionals and patients get the medicines, knowledge and support they need. We believe in our values: We empower everyone/We rise to the challenge/We work as one/We ask what if/We do the right thing, and we will ask you how your personal values align to them. To learn more about Inizio Engage, visit us at: ___ Inizio Engage is proud to be an equal opportunity employer. Individuals seeking employment at Inizio are considered without regards to age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition (including pregnancy, childbirth, or related medical conditions), mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. Further, pursuant to applicable local ordinances, Inizio will consider for employment qualified applicants with arrest and conviction records. Inizio Engage is an equal opportunity employer M/F/V/D. We appreciate your interest in our company, however, only qualified candidates will be considered.

Inizio Engage has a long-standing partnership with Genentech, a leading Biotechnology company, across Commercial, Patient Solutions and Medical Affairs businesses. We are seeking a performance-driven, competitive, highly entrepreneurial and analytical Sales Leader who is willing to put forth discretionary effort to ensure their district is meeting and exceeding expectations. This is a highly innovative role requiring you to lead by example to drive district performance, think outside of the box and continually challenge your team to go the extra mile. This is your opportunity to join Inizio Engage and represent a top biotechnology company! What’s in it for you? • Competitive compensation, • Excellent Benefits – accrued time off, medical, dental, vision, 401k, disability & life insurance, paid maternity and paternity leave benefits, employee discounts/promotions, • Employee discounts & exclusive promotions, • Recognition programs, contests, and company-wide awards, • Exceptional, collaborative culture, • Best Places to Work in BioPharma (2022, 2023, & 2024), • Certified Great Place to Work (2022, 2023, 2025) What will you be doing? • Recruit, hire and manage a high performing team, • Create and drive district strategy and short term tactics to achieve business goals in a timely manner, • Work in the field with sales representatives to coach and counsel on improvement of selling skills, product knowledge, and capabilities needed for successful representative development and maximum goal achievement, • Monitor data analytics information (sales trends, activity, market share) continuously to ensure full utilization of available resources and tools for maximum impact on prescribing providers while constantly looking for opportunities to improve, • Drive call plan adherence and execution, • Ensure that the given geography meets or exceeds all sales targets and goals, • Set a positive tone and high standard for the district team in terms of work ethic, culture, expectations, business ethics, • Assess competitive threats and take appropriate action, • Aid in design of business plans, employee development plans, monthly reports as required, • Organize employee training, conferences and district meetings, • Work with representatives to share success stories and adapt best practices with the district and across the nation, • Communicate with key sales leadership regularly (written and verbal) to update on project performance, gain feedback, build relationships, and network to identify future opportunities What do you need for this position? • Bachelor’s Degree from an accredited College or University or equivalent work related experience, • Ability to influence team member activities, • At least 5 years of sales management experience within the Pharmaceutical, Biotechnology or Healthcare Industry is required with proven ability to develop and motivate others, lead through change, and deliver on set objectives. Primary care experience preferred, • Ability to recruit, retain, and develop a high quality team, • A deep understanding of the pharmaceutical and healthcare industries, • Lead a team and reinforce strong account management skills - i.e., the ability to work an account to include health systems/urgent care centers/pharmacies to gain access and support pull through, • Product launch experience preferred, • Must consistently demonstrate sound judgment and strategic decision-making abilities, • Strong organizational and analytical skills are also required and ability to analyze and draw appropriate conclusions using sales and call reporting data, • Professional, proactive demeanor, • Ability to interpret and utilize business data to drive positive business results, • Strong interpersonal skills and ability to build business relationships, • Results-driven with exceptional attention-to-detail and knowledge around metrics, • Overnight travel may be required (depending on geographical location), • Valid Driver’s License, • Computer/iPad proficient About Inizio Engage Inizio Engage is a strategic, commercial, and creative engagement partner that specializes in healthcare. Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people and providers to improve treatment outcomes. Our mission is to partner with our clients, improving lives by helping healthcare professionals and patients get the medicines, knowledge and support they need. We believe in our values: We empower everyone/We rise to the challenge/We work as one/We ask what if/We do the right thing, and we will ask you how your personal values align to them. To learn more about Inizio Engage, visit us at: ___ Inizio Engage is proud to be an equal opportunity employer. Individuals seeking employment at Inizio are considered without regards to age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition (including pregnancy, childbirth, or related medical conditions), mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. Further, pursuant to applicable local ordinances, Inizio will consider for employment qualified applicants with arrest and conviction records. Inizio Engage is an equal opportunity employer M/F/V/D. We appreciate your interest in our company, however, only qualified candidates will be considered.

Inizio Engage has partnered with Tonix Pharmaceuticals and are seeking performance-driven, competitive, highly entrepreneurial, and analytical Regional Sales Manager who are willing to put forth discretionary effort to ensure their region meets and exceeds expectations. This is a highly innovative role requiring you to lead by example to drive district performance, think outside of the box, and continually challenge your team to go the extra mile. This is your opportunity to join Inizio Engage and be part of an exciting opportunity to represent a leading biotechnology company preparing for an upcoming launch in the fibromyalgia space! What’s in it for you? • Competitive compensation, • Excellent Benefits – accrued time off, medical, dental, vision, 401k, disability & life insurance, paid maternity and paternity leave benefits, employee discounts/promotions, • Employee discounts & exclusive promotions, • Recognition programs, contests, and company-wide awards, • Exceptional, collaborative culture, • Best Places to Work in BioPharma (2022, 2023, & 2024), • Certified Great Place to Work (2022, 2023, 2025) What will you be doing? • Ensure that the given geography meets or exceeds all sales targets and goals, • Recruit, hire, manage, and develop/coach a high performing team, • Create and drive region strategy and short-term tactics to achieve business goals in a timely manner, • Execute Consistent and Frequent Performance Management with Sales Team, • Work in the field with sales representatives to coach and counsel on improvement of selling skills, product knowledge, and capabilities needed for successful representative development and maximum goal achievement, • Monitor data analytics information (sales trends, activity, market share) continuously to ensure full utilization of available resources and tools for maximum impact on prescribing providers while constantly looking for opportunities to improve, • Set a positive tone and high standard for the regional team in terms of work ethic, culture, expectations, business ethics, • Assess competitive threats, best practices and field learnings and share as appropriate., • Aid in the design of business plans, employee development plans, monthly reports as required, • Organize, participate in employee training, conferences, and regional meetings, • Collaborate with Market Access and Patient Access on a regular basis., • Collaborate with Medical Affairs as appropriate, • Drive call plan adherence and execution, • Communicate with Tonix key sales leadership regularly (written and verbal), • Maintain compliance standards What do you need for this position? • Bachelor’s degree in business, science, or related field or equivalent work experience, • Ability to influence team member activities, • At least 3 years of sales management experience within the Pharmaceutical, Biotechnology or Healthcare Industry is required with proven ability to develop and motivate others, lead through change, and deliver on set objectives., • Product launch experience highly preferred, • Rheumatology and/or CNS experience preferred, • CSO field management experience plus, • Ability to recruit, retain, and develop a high-quality team, • A deep understanding of the pharmaceutical and healthcare industries, • Greater than 50% travel including overnights with be required About Inizio Engage Inizio Engage is a strategic, commercial, and creative engagement partner that specializes in healthcare. Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people, and providers to improve treatment outcomes. Our mission is to partner with our clients, improving lives by helping healthcare professionals and patients get the medicines, knowledge and support they need. We believe in our values: We empower everyone/We rise to the challenge/We work as one/We ask what if/We do the right thing, and we will ask you how your personal values align to them. To learn more about Inizio Engage, visit us at: ___ Inizio Engage is proud to be an equal opportunity employer. Individuals seeking employment at Inizio are considered without regards to age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition (including pregnancy, childbirth, or related medical conditions), mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. Further, pursuant to applicable local ordinances, Inizio will consider employment qualified applicants with arrest and conviction records. Inizio Engage is an equal opportunity employer M/F/V/D. We appreciate your interest in our company; however, only qualified candidates will be considered.

Job DescriptionQuality Control Analytical Associate IIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Control Analytical Associate II serves as a support role to clinical and commercial production. The QC Analytical Associate II will assist with process check point, stability, and release analytical testing to ensure that quality standards are upheld for all products produced at the facility. Under the direction of the Manager, QC Analytical Associate II, responsibilities include: • Performs the accurate execution of all company and/or client test methods and procedures of cellular products to ensure the safety and/or efficacy of different cell populations, • Performs maintenance, monitoring, and troubleshooting of pertinent equipment, • Performs and assists in the training of other Quality Control technicians, • Maintains training records and coordinates records retention with Document Control and Training groups, • Tests, documents, and reports results for products or materials following company and/or client procedures following CGMP and/or GTP guidelines, • Performs state proficiency testing and/or client proficiency testing under direct supervision as applicable, • Participates in managing QC materials and supplies, • Performs and assists in equipment and method qualification/validation activities as needed, • Performs reagent and media preparation, • Provides input based on level of knowledge and experience with troubleshooting malfunctioning equipment, • Investigates out-of-specification, out-of-trend, aberrant, and/or non-conforming test results, • Initiates, investigates, and prepares deviation reports with input from assigned supervisor, • Brainstorms and implements corrective and preventive actions, as and when applicable, • Documents training and execution of shipping test samples to contract laboratories for testing, • Completes all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP), • Communicates effectively with other co-workers, departments, management and clients, • Eventually serves as a lead and/or co-lead for client projects, • Additional tasks as assignedREQUIREMENTS, • BA/BS in a science or relevant field required, • Prior cGMP experience required, • Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment preferred, • Prior industrial experience in cell count methodologies preferred, • Prior academic and/or industrial cell therapeutic experience preferred, • Minimum 2-5 years of experience in Quality Control laboratory setting or within the biopharmaceutical industry, • Proficient with computer software such as: Microsoft Office, Visio, • Strong written and oral communication skills, • Strong presentational skills preferred, • Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities.Other Information, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens., • Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays, and as required by the company, • Must be able to handle the standard/moderate noise of the manufacturing facility, • The QC Analytical Associate II must be able to work in a laboratory environment for an extended period., • Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hearPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. QC Analytical Associate I is available as well.

Job DescriptionQuality Control Microbiology Engineer III Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer III will coordinate data for batch release, participate in project/client meetings, and author/revise microbiological testing procedures. Additionally, the incumbent will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates microbiological testing data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Engineer II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work orders, • Other duties as assignedREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • Minimum required training; GxP/GDP Training, Safety Training, • Proficient with computer software such as; Microsoft Office, MODA/LIMS; Microsoft Visio (preferred); Netsuite (preferred); Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experienceMust be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesSupervisory Responsibility; Direct reportsWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels.Must have the ability to work in a team-oriented environment and with clients.Must be able to work during the weekend, holidays and as required by the company.Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy.Must have the ability to work in a team-oriented environment and with clientsMust be able to work during the weekend, holidays and as required by the companyMust be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionSenior Facilities TechnicianAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Senior Facilities Technician position is responsible for performing and documenting the required maintenance and monitoring of the facility, systems and equipment. The required duties include execution of Preventive and Corrective/General/Emergency maintenance on the facility’s mechanical systems and equipment, installation of new equipment and general plumbing, electrical and carpentry work, operation of the facility’s systems, including HVAC, environmental monitoring and BMS systems, and other duties as assigned. The position is required to perform the listed duties to minimize equipment downtime, support projects, and ensure that the needs of internal and external customers are met. The objective of this position is to ensure the facility is maintained in a state of maximum uptime and reliability, and provide a safe, clean and efficient environment. • Monitor and respond to equipment or facility alarms, • Travel to and support different sites when necessary., • Work with facilities, engineering and operations to ensure schedules are maintained and delays are properly communicated to customer., • Be available to work nights or weekends, on a rotating basis, to service company needs., • Maintain proper stock, parts, tools, and safety equipment., • Take orders from supervisors for maintenance and repair of systems and buildings, • Clear and clean job sites of debris and other hazardous materials and ensure that they are restored to their original states, • Assist mechanics and other technical staff in testing, cleaning and repairing utility systems, • Provide support in repairing potholes and gutters, • Assist office staff in custodial services and grounds keeping activities, • Clean and maintain floor surfaces, ceilings and windows, • Empty trash receptacles and ensure appropriate disposing off of trash, • Clean restrooms and replenish supplies, • Move equipment and furniture around the building, • Assist stock personnel in handling inventory duties along with providing support in receiving, verifying and storing office supplies, • Maintain full knowledge of the environmental monitoring system as required for monitoring equipment and troubleshooting issues as they relate to equipment and the facility Systems., • Perform all assigned PM’s and WO’s on equipment., • Document all work as performed according to cGMP’s and HCATS SOP’s., • Provide ongoing insight to Supervisors where SOP’s and PM Job Plans need to be updated. Assist Supervisors as required in the preparation of change controls or other required documentation., • Maintain cleanliness of the Facility and Maintenance areas., • Maintain 100% training records for all required training., • Provide 24-hour emergency response as required., • Perform any work required to ensure the safety of the facility and staff, including snow/ice removal as required., • Coordinate contractors, ensure contractors are properly trained and the training is documented before any work is performed., • Perform all duties in accordance with all applicable safety regulations., • Monitor overall job environmental, health and safety aspects and understands the risks and liabilities associated with various facilities maintenance and repair activities., • Must be able to recognize hazard conditions, take appropriate work place safety measures and wear appropriate personal protective equipment to suit work environment.REQUIREMENTS, • 3 to 5+ years of experience in Facility Maintenance., • Good analytical skills and attention to detail with ability to read and interpret blueprints, plans, and manuals., • Excellent customer service skills with desire to exceed customer expectations., • Ability to work independently in a timely manner, ensuring job is done correctly the first time., • Experience in a cGMP environment preferred., • Must be able to communicate clearly and effectively, both written and verbally., • Must be able to work independently and in a team environment, • Must train and become gown qualified to enter and work in classified manufacturing areas., • Valid driver’s license and clean driving record, • Must be able to pass drug test(s) as required by company, • This job may require occasional evening and weekend work.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Rumi Scientific is a research-driven company leveraging a standardized human organoid platform for drug discovery. Our focus is on the discovery and validation of new therapeutic candidates for CNS disorders with large unmet needs from neurodegeneration to neurodevelopmental disorders, as well as nephrology. Our core technology harnesses the power of pluripotent stem cells to model human development in vitro, combining accurate genetic models of human diseases together with multi-cellular self-organization on bioengineered substrates to create defined pathological tissues that serve as a basis for drug screening. We have developed an innovative analysis pipeline based on deep-learning algorithms to analyze high-throughput screening results to more rapidly identify molecules which will rescue disease phenotypes before pushing these compounds towards the clinic. Our ability to model complex human tissues in both normal and disease contexts, in a unique standardized and high throughput manner, will open new doors towards treatments for many genetic disorders that still have no cures. We are seeking a highly motivated Lab manager to join our growing team. The successful candidate will contribute to the company effort by providing a safe, organized and functional working environment in support for the scientific research team. The ideal candidate is a capable, self-motivated, and dynamic personality. The Lab Manager will play a key role in ensuring the smooth operation of our laboratory. This individual will be responsible for maintaining lab infrastructure, managing inventory and vendors, enforcing safety protocols, and supporting scientists with logistical and technical needs. This is a hands-on, cross-functional role ideal for someone who thrives in a fast-paced, collaborative start-up environment. The ideal candidate will have extensive experience in the biological sciences/bioengineering. The applicant can adapt to the challenge of working with cutting-edge biotechnology, to quickly master independence. Teamwork is essential to our success; you should thrive in a collaborative environment. The key responsibilities of this position include: 1. Maintains laboratory organized., 2. Takes inventory of shared supplies, request supplies on Quartzy procurement platform., 3. Organize receiving of incoming supplies., 4. Aliquots shared supplies and reagents, prepares media for scientists & assists scientific teams on projects upon request., 5. Manage all lab equipment, preventative maintenance, and service contracts with applicable vendors., 6. Collaborates with the science team to address any workflow bottlenecks, inefficiencies, or opportunities for process improvements. Attends weekly team meetings as well as weekly lab operations meetings., 7. Training of new members in Laboratory Maintenance & Hazards (with laboratory tour, workflow, where supplies are located etc.), go over Training Modules and Training Standard Operating Procedure., 8. Monitor proper waste management, removal and pick-ups of hazardous waste., 9. Ensure laboratory safety standards are followed, all licenses are up to date, create and implement high quality standards of good lab practices, help to create, and influence safety policies, and collaborate with local safety representatives- (Stericycle. C14, FDNY permits, etc)., 10. Maintain laboratory safety standards and monitor any safety issues., 11. Develop and maintain vendor relationships in support of the Laboratory., 12. Under emergency situations provide “on-call” support and regular 24-7 operation of laboratory to ensure appropriate response to equipment issues as needed (Refrigerators, Freezers, etc)., 13. Expands cell lines for cell banking and maintains organized cell banks by keeping Benchling updated with cell vial inventory. Performs quality control of cells by routine Microplasma Testing., 14. Assist scientist with experiments when time allows: cell culture, PCR, qPCR, WB, experimental planning. Experience and Required Skills: • B.S./M.S. degree in biological sciences or related field from a top college/university., • Ability to work independently as well as in a team setting, to meet critical deadlines., • Experience in the functioning of a biology R&D lab (>1-2 years) and ideally stem cell research., • Excellent organizational skills., • Experience working in a collaborative environment., • Willingness to learn new technologies and skills. Job Type: Full-time Salary: $60-90k/year depending on experience

Rumi Scientific is a research-driven company leveraging a standardized human organoid platform for drug discovery. Our focus is on the discovery and validation of new therapeutic candidates for CNS disorders with large unmet needs from neurodegeneration to neurodevelopmental disorders, as well as nephrology. Our core technology harnesses the power of pluripotent stem cells to model human development in vitro, combining accurate genetic models of human diseases together with multi-cellular self-organization on bioengineered substrates to create defined pathological tissues that serve as a basis for drug screening. We have developed an innovative analysis pipeline based on deep-learning algorithms to analyze high-throughput screening results to more rapidly identify molecules which will rescue disease phenotypes before pushing these compounds towards the clinic. Our ability to model complex human tissues in both normal and disease contexts, in a unique standardized and high throughput manner, will open new doors towards treatments for many genetic disorders that still have no cures. We are seeking one highly motivated Research Assistant to join our growing team. The successful candidate will contribute to the drug discovery effort as well as the development of novel therapeutics across several areas based on a strong interdisciplinary background, as our interests range from genome editing, bioengineering for scalable micro-tissue production, to machine learning approach for the analysis of high content phenotypic screens. The ideal candidate is a capable, self-motivated, and dynamic personality. You will be working closely with our CSO and Head of Biology to expand our portfolio of diseases and development of human stem cell screening platforms for drug discovery and characterization. The ideal candidate will have extensive experience in the biological sciences/bioengineering, with duties mostly including tissue culture, molecular biology and microscopy. The applicant can adapt to the challenge of working with cutting-edge biotechnology, to quickly master independence. Teamwork is essential to our success; you should thrive in a collaborative environment. The key responsibilities of this position include: • Human pluripotent stem cell culture., • Molecular Biology techniques., • Proprietary organoid generation, staining and imaging., • Maintain detailed laboratory notebook and other documentation, protocols, and records, incl. reporting to the senior management. Experience and Required Skills: • B.S./M.S. degree in biological sciences or related field from a top college/university., • Ability to work independently as well as in a team setting, to meet critical deadlines., • Excellence in the fundamentals of molecular biology and cell biology., • Excellent organizational skills., • Experience working in a collaborative environment., • Willingness to learn new technologies and skills. Job Type: Full-time Salary: $60k/year

About Serinus Serinus Biosciences is an AI drug discovery company targeting the convergence of cancer signaling. Protein-protein interactions (PPIs) form the physical core of signaling networks that drive disease emergence and progression. Our Pep-to-Mol platform leverages recent advances in protein structure prediction and our proprietary PPI energetics database to convert any peptide binder, including the natural binding protein itself, to a potent small molecule inhibitor. We have recently established a number of hit series for a previously undruggable PPI targets in under 4 months of development. Our lead program is a first-in-class PPI target with a market opportunity of >$20B (in the US alone) across a diverse set of lethal solid tumors. We operate at the cutting edge of AI, biology, and drug design, to develop novel treatments for patients in need. Founded by MIT graduates, Serinus Biosciences is supported by leading investors, including Illumina Ventures, Vertex Ventures, Y-Combinator, and Merck Digital Science Studios. Our work has been published in leading journals, including Science, Cell, Nature Biotechnology, and Cancer Cell. Our advisory board includes world-renowned researchers from the Broad Institute, Dana Farber Cancer Institute, and UCSD. Join our team to help shape the next generation of cancer treatments! About the role We are looking to add a new member to our computational team. In this role, you will be at the intersection of cutting-edge machine learning, computational chemistry, and drug discovery. You'll work directly on our Pep-to-Mol platform alongside our experienced drug discovery team to transform the landscape of therapeutics, turning previously intractable PPI targets into viable drug candidates. The ideal candidate likely has a scientific background in the life and/or hard sciences, is deeply excited by the recent breakthroughs in biomolecular structure prediction (e.g. AlphaFold) and other approaches to understand and exploit biology using massive datasets, and enjoys bending computers to their will. Your key responsibilities will include: · Execute computational workflows to analyze experimental results from our wet lab and process data from external resources. · Manage and optimize the company’s software infrastructure to enable rapid feedback loops between computational design and the wet lab testing. · Contribute to the continuous improvement of our Pep-to-Mol platform through workflow automation and algorithm development. · Present findings to cross-functional teams and external stakeholders, translating complex computational insights into actionable drug discovery decisions. About you The tangible · Bachelor’s degree (or higher) in computer science, data science, ML or related field. · Advanced coursework in biological sciences, biophysics, biochemistry, or closely related field. · Exceptional programming skills in Python, proficiency in bash scripting, and experience with standard software engineering practices. · Track record of working independently on scientific and/or technical project. · Hands-on experience working with large-scale datasets and data management on cloud-based environments (e.g., AWS, GCP, Azure). · Collaborating to solve hard problems is better in-person. Candidates will be expected to work on-site in our NYC office (Manhattan). The intangible · Impact-driven and motivated to cure human diseases. · Problem-solver who thrives in fast-paced environments. · Eager to move fast and contribute to the culture of a small team. · Open to giving and receiving feedback. Big bonus · Prior experience with cheminformatics tools, using machine learning libraries, or running workflow execution infrastructure. · Prior experience designing or running bioinformatics workflows for analyzing omics data. About the offer · Salary range: $75K-$95K · Above market equity package. · A fast growth trajectory with us at Serinus! · Premium-level health, dental and vision insurance at 100% coverage. · Access to Flexible Spending Account (FSA). · Access to commuter benefits. · Unlimited PTO days + 10 federal holidays. · Gratitude access to an on-site gym at our New York City’s offices. · An energetic team excited to solve cancer! One more reason to join us We are a tight-knit and motivated team at the cutting edge of what we do. You will learn a ton and be trusted with extreme ownership. When we succeed, patients benefit!

Job Description Director/Sr. Director of Drug Product CMC Location: New York City, NY Company Overview: We are partnered with a dynamic clinical-stage biotechnology company focused on developing innovative therapies to address unmet medical needs. They are dedicated to advancing science and improving patient outcomes across several treatments and therapies. Their portfolio consists of assets across early and late stage development. Job Summary: The Director/Sr. Director of Drug Product CMC will lead and oversees drug product development, manufacturing, and regulatory activities to ensure high-quality products are delivered from early development through commercialization. This role involves cross-functional collaboration to support product lifecycle management, process optimization, and regulatory compliance for drug products, ensuring all CMC strategies align with company goals and regulatory standards. The Director/Sr. Director will provide technical and strategic leadership, working closely with internal teams and external partners to meet critical project milestones. Key Responsibilities: • Lead the development and implementation of CMC strategies for drug product development and manufacturing., • Oversee technology transfer to and from contract manufacturing organizations (CMOs) and provide technical oversight of drug product manufacturing., • Ensure compliance with cGMP regulations and manage quality assurance activities, including deviation management, batch record reviews, and lot disposition., • Develop and manage risk-based strategies for CMO oversight, considering product lifecycle, technical complexity, and CMO capabilities., • Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, Clinical Development, and Supply Chain, to ensure timely delivery of drug products., • Support regulatory submissions by providing CMC-related documentation and expertise., • Lead process optimization, validation, and continuous improvement initiatives., • Manage the drug product manufacturing budget and long-range planning., • Serve as a subject matter expert during regulatory inspections and audits. Qualifications: • Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field, with 10+ years of experience in CMC and drug product development (or equivalent industry experience for those with a Ph.D.)., • Strong knowledge of cGMP regulations, ICH guidelines, and CMC content of regulatory submissions., • Proven track record in CMC regulatory submissions (IND, IMPD, NDA), • Experience managing CMOs and overseeing technology transfer processes., • Excellent problem-solving, project management, and communication skills., • Ability to work collaboratively in a fast-paced, dynamic environment., • Familiarity with quality-by-design (QbD) principles, statistical analysis, and DOE., • Willingness to travel as needed (up to 10%). What We Offer: • Opportunity to lead in a dynamic, fast-growing company with a strong pipeline of innovative therapies., • Collaborative work environment with professional development and career growth opportunities.

Job DescriptionQuality Assurance Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the (Associate) Manager of Quality Assurance (Floor support). Responsible to perform Quality Assurance Compliance activities in support of company and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients. • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to conduct investigation and CAPA processes., • Conduct investigation and identify true root cause using appropriate tools., • Manage multiple investigations in different stages of the process to meet compliance deadlines and product release dates., • Reviews and approves investigations and CAPAs when required;, • Collaborate with cross functional department to develop and track CAPA plans., • Prepares and issues change control as necessary., • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures., • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations., • Conducts trend analysis of compliance related metrics such as deviations and CAPAs., • Performs supplemental investigations and/or participates in project teams or assignment as necessary., • Support in agency, internal and/or client audits., • Other duties as assigned.REQUIREMENTS, • B.S in biological sciences or other relevant field of study., • Minimum 5 years’ experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Familiar with FDA, ISO, and other regulatory agency guidelines., • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required., • Working knowledge and technical understanding of aseptic manufacture of biologics preferred., • Experience in both clinical and commercial manufacturing is preferred., • Experience in supporting health authority inspections and/or client audits preferred., • Competencies/Candidate Profile, • Relevant computer skills (Microsoft Office, Outlook), • Detail-oriented and organized, • Analytical and problem-solving skills, • Good written and oral communication skills, • Ability to multi-task and be adaptable, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work independently and with a team, • Strong Project Management and organization skills, • Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit., • Must be able to work in a team-oriented environment., • Must be able to work occasional weekends, nights, and/or holidays as required/necessary., • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids., • Must be able to handle the standard moderate noise of the manufacturing facility., • Must be able to work in open floor plan environment and may work in close proximity to others., • Wheel-o-Vator available for use. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionHuman Resources Manager Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. Support the continuous improvement of the HR function through development and implementation of HR programs. Provide comprehensive HR support to employees and management across assigned service departments. • Support line managers in the process of new employee orientation., • Provide HR Partnering management coaching and counseling., • Act as HR Business Partner to assigned business areas., • Provide Compensation analysis and reporting., • Design and execute recruitment strategies., • Support line managers in the recruitment and selection process where appropriate., • Manage employee relations which emphasizes open communications, equal opportunities and treatment, • Manage HR-related queries and may work independently or in conjunction with senior members of the HR team and line management on issues.REQUIREMENTS, • Bachelor's Degree Required, • 7 years experience within an HR function as generalist; ER, Compensation, TA strategy., • 5+ years pharmaceutical industry., • Expert coaching and counseling skills, • Good computer skills, including Microsoft Office applications and HRIS applications, • Strong verbal and written communication skills and very good interpersonal skills

Job DescriptionHuman Resources ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Human Resources Business Partner will provide human resources consultation and support to assigned divisions. Understand business needs in order to assess the human resources implications of various business strategies. Acts as liaison to other functions to ensure achievement of business objectives. Provides staffing and placement support to departments and divisions. Facilitates the recruitment and on-boarding process for all new hires. This position is both operational and strategic in nature and provides HR expertise in the areas of talent management, organization design and effectiveness, performance management, employee relations, employee engagement, compensation, retention and process improvement initiatives. This role will report to the Sr. Director, Human Resources and will serve as a business partner to the Quality Leadership team and function. In addition, this role supports, implements, and executes all tactical aspects of the HR function. • HR Leadership: Coaching, developing and providing guidance to HR team members within assigned groups., • Business Partner: Serving as a true business partner and advisor, gaining the trust of the organization in order to influence and provide effective HR processes, advice and support., • Talent Acquisition: Designing and executing workforce planning and recruitment strategies that attract and retain the best talent in the industry., • Organization Effectiveness: Serves as a change agent in the organization, sponsoring change initiatives in support of organizational evolution., • Employee Relations: Promoting a philosophy of employee relations throughout the company which emphasizes open communications, equal opportunities and treatment, continuous learning and reflects our core values., • HR Expert: Acting as a subject matter expert within the organization and providing interpretation, recommended best practices and ensures compliance with key legal requirements and adherence to company policies and procedures., • Compensation: Ensures our compensation practices continue to attract and reward top talent. Overseeing salary administration to include annual performance management and compensation processes., • Continuous Improvement: Analyzing trends and metrics in partnership with the HR team to draw insights, develop solutions, programs and policies.REQUIREMENTS, • Bachelor’s degree in business, Human Resources or related field., • HR Certification (PHR, SHRM-CP) or ability to obtain certification within one year of employment., • 10 + years progressive HR/business leadership experience is required., • 5+ years in clinical and/or pharmaceutical industry., • Demonstrated ability to build credibility and confidence with a wide variety of employees and leaders as a trusted advisor and confidant., • Ability to influence individuals at all levels of the organization., • Strong problem solving and conflict resolution skills., • Prior experience in working in a matrix and complex operating environment preferred. fast paced, challenging industry., • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance., • Highly ethical, authentic and committed to high integrity., • Learns, fast, while being adaptable to the changing environment., • Looks to raise the bar of service delivery and always seeks ways to address the status quo looking for ways to improve., • Communications proficiency: for both written and verbal communication., • Works collaboratively with all levels of employees., • Works with a composed attitude and behaves accordingly., • Action oriented with results, executes on all assigned goals and objectives.

Job DescriptionSupplier Quality AuditorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Supplier Quality Auditor ensures and promotes compliance through external auditing of company's suppliers; vendors/ laboratory services/service providers/manufacturers for the Allendale, NJ and Mountain View, CA sites based on company's procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7, Q9, Q10, 21 CFR Part 11 and Data Integrity and Eudralex Volume 4 Guidelines.The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for company and management of the Approved Supplier List. The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites. • Develop and maintain a risk-based external auditing program for company harmonized across all sites., • Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all company facilities to ensure complete profile., • Management of ASL to add suppliers and maintain approval status of all suppliers as needed., • Based on ASL status, conduct reviews and perform audits to qualify each supplier used., • Prepare external audit schedule and conduct audits per the schedule., • Prepare and complete audit reports and communicate audit information to cross functional teams within company and supplier within a timely manner., • Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures., • Track audit findings for suppliers to completion and ensure timely closure of audit reports., • Act as a quality lead and liaison between suppliers and internal teams to identify new suppliers and identify and communicate issues that may impact quality, system gaps or cause interruptions in business continuity., • Maintain metrics on supplier audit findings used for oversight, qualification status, continuous improvement, and/or opportunities for reduction/alternate suppliers., • Maintain audit files and ensure all files are properly archived., • Author and review External Auditing, Supplier Qualification and Supplier Management Program and/or Quality Systems SOPs, as needed., • Ensure that Quality Agreements are generated and enforced at each supplier., • Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs., • Assist in other Quality System related responsibilities and provide Quality related support to various departments, as needed.REQUIREMENTS, • Minimum 5-8 years quality systems auditing experience in pharmaceutical, biologics, or medical device industry., • Auditor qualifications and certifications such as Certified Quality Auditor (CQA)/ASQ Certification, ISO Certification, etc., • Experience with auditing raw materials/excipients, components, and analytical and micro laboratories., • Proven ability to identify, collaborate, and resolve supplier related compliance issues., • In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), ICH Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) and Data Integrity principles,, • EU and PMDA regulations knowledge and associated guidelines are a plus., • Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences., • Certified Auditor or Lead Auditor credentials required., • Understanding of the manufacture and testing of cellular and gene therapies is desirable., • Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation., • Experience in Quality Assurance, including the ability to identify and resolve compliance issues., • Sound knowledge of aseptic processing and supporting technologies., • Must have exceptional written and oral communication skills., • Exhibit professional mannerisms when dealing with Clients/Suppliers and company personnel, • Ability to multi-task is essential., • Proficiency with IT skills, such as MS Office (Word, Excel, Outlook, PowerPoint) and SharePoint., • Ability to think strategically and tactically (strong detail-oriented)., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team matrixed environment as well as independent contributor., • Strong analytical and problem-solving skills., • Flexible and able to adapt to company growth and evolving responsibilities., • Multi-disciplinary knowledge across GxP functional areas., • Excellent organizational skills including efficiency, punctuality and attention to detail and managing multiple priorities., • Good verbal, written communication, and presentation skills., • Demonstrable multitasking, project management, and execution skills., • Good business acumen and strong team-oriented interpersonal skills, including communication, presentation, negotiation, influence., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to handle the standard/moderate noise of the manufacturing facility, • Travel required (approx. 50%)Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Our Company Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry instrumentation, and the full range of reagents for IHC lab testing. Biocare specializes in high quality IHC, ISH, and FISH slide staining through its brand-new automated instrument, NeoPATH Pro™, and offers best-in-class simultaneous Multiplex IHC solutions. The company's customers include clinical histology laboratories, pharmaceutical companies, CROs, biotechnology companies as well as academic, government, military, and non-profit laboratories. Biocare Medical offers an expanding portfolio of integrated products to address the rapidly growing cancer and infectious disease diagnostic and research markets with novel tissue immunohistochemistry and in situ hybridization methods. Biocare Medical is headquartered and has manufacturing facilities in California with a global distribution network. The Opportunity Responsible for revenue generation, new customer acquisition, and profitable promotion of Biocare reagent products (IHC, ISH, Detection, Ancillaries) to existing and future customers. Focus on customers in clinical markets as well as research/pharmaceutical/biotech markets. Focus on immunohistochemistry laboratories, in-situ hybridization laboratories, and general pathology and histology markets. Also, responsible for revenue generation, new customer acquisition, and profitable promotion of Biocare Instrumentation (Oncore PRO, Oncore Pro X, intelliPATH+, intelliPATH MAX, Antigen Retrieval Chamber, Other equipment) to existing and future customers. Focus on customers in clinical markets as well as research/pharmaceutical/biotech markets. Focus on immunohistochemistry laboratories, in-situ hybridization laboratories, and general pathology and histology markets. Territories Available • Meets Annual quota and annual goals set forth in the defined territory., • Seeks out prospective customers/business opportunities with new and existing customers., • Establishes and maintains customer relationships with focus on growing profitable instrument placements., • Manages territory with CRM tools and analyze trends via Business Intelligence tools to maximize revenue., • Introduces and demonstrates new products to existing and new accounts., • Generate quotations, instrument proposals, and instrument contracts to secure new business., • Report competitive conditions and feedback from customers to management., • Maintains ethical, cooperative manufacturer relationships consistent with company image and company/branch goals in the marketplace., • Coordinate the sales process across the entire value chain including lab techs, lab managers, pathologists, procurement and any individual involved in the decision-making process., • Completes sales calls and expense reports on a timely basis in accordance with company policy., • Develop and maintain sales forecast to help analyze market conditions and/or changes in assigned territory for maximum productivity and sales growth., • Map existing and target accounts with SFDC ClosePlan™ to ensure proper deployment of the Biocare Playbook., • Coordinate customer returns and completes proper documentation on a timely basis., • Bachelor's Degree required with three to five (3-5) years of relevant Sales and Industry experience., • Strong entrepreneurial spirit and able to work in a changing environment with multiple demands., • Self-assured problem solver capable of making risky decisions., • Strong motivation and drive in selling skills, negotiating, and closing deals., • Exceptional attention to detail and follow through., • Exceptional time management and organizational skills., • Ability to communicate clearly and concisely in written and verbal formats, including sales presentations, demonstrated capability to develop strong interpersonal working relationships and work in a team environment., • Excellence in CRM (SalesForce.com), Business Intelligence (Tableau), and other sales tools as launched., • Proficiency in the use of a personal computer accompanied by a strong aptitude for technical applications., • Ability to travel 80%-90% of the time., • Company Sponsored Health Insurance - Medical, Dental, Vision, • Company Sponsored Life Insurance, • Voluntary Benefits, • Retirement plan with a match - 401(k), • PTO, • Paid Holidays All inquiries strictly confidential.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . The Preclinical Principal Scientist will serve as a key scientific contributor, subject matter expert (SME) and Project Manager in the execution of Cresilon’s Preclinical Research Operations, including but not limited to in-vivo study design (Safety and Efficacy/Functionality evaluations), Preclinical Research Management, Vendor Management, and Preclinical Regulatory Strategy. This will include the development and execution of strategies for preclinical evidence necessary to competitively position a project’s product for domestic and international regulatory and clinical acceptance. This position as a hybrid role, with work off-site at CRO in NY/NJ area, work from home and on-site at Brooklyn NY. Job Responsibilities: The Preclinical Research Scientist will: • Lead, staff, and manage Cresilon’s Preclinical Research activities., • Provide preclinical scientific input and leadership on the evaluation of physical safety and efficacy for technologies and products at all stages of the product life cycle., • Plan, direct, coordinate and execute activities related to the design, initiation and follow-up of studies to support approval of Class I-III medical devices., • Develop, write, and/or review study protocols and reports. Act as technical mentor for the development of study experimental designs, protocols, and reports of junior associates., • Administrate and manage Cresilon preclinical regulatory strategy and communication., • Work with Contract Research Organizations (CROs) to execute both Biocompatibility / Safety and Efficacy/Functionality research, including negotiating, drafting, and managing research contracts and agreements with pre-clinical trial sites., • Ensure that company operates within the scope of regulatory compliance including Quality System Regulations (ISO 13485), health and safety, environmental protection regulations, and the core values of Cresilon., • Be a Subject Matter Expert (SME) for preclinical research department growth strategy. Actively interact with the internal and external scientific community to maintain state of the art knowledge., • Oversee the development of and modifications to preclinical models to address project needs., • Oversee the design and execution of preclinical functionality and safety in-vivo studies per project timelines., • Surveys the literature to identify and compare competitive product performance and safety risks., • Maintain current knowledge in existing regulations, requirements and standards, including but not limited to global regulatory requirements (ISO, FDA, etc) and compliance requirements (GLP, USDA, AAALAC, departmental SOP's, company policies, etc), • Work cross functionally with Regulatory and Quality to assess project risks, product safety and efficacy on NPD projects, including ensuring external facilities meet Cresilon standards for animal use and generating contracts and CRO audits, if necessary., • Manage budgetary requirements for all research projects to support efficacy and safety programs., • Lead the effort to publish surgical research in peer-reviewed journals., • Regularly interface with management to ensure research operations reflect overall corporate vision/strategy., • DVM, PhD or MD in a relevant discipline is preferred. A Bachelor's in a technical or scientific field is required., • Minimum 6+ years’ experience in preclinical medical device research is required, preference given to veterinary surgical or human surgical experience., • 4+ years of people management experience preferred., • Extensive knowledge of surgery, anatomy, toxicology, and pathology is required., • Experience with planning, directing, and coordinating activities related to studies to support approval of Class I-III medical devices is highly preferred., • Experience in a medical device, pharmaceutical, or related setting with a proven record of success in supporting studies for R&D projects is highly preferred., • Strong knowledge of ISO-10993 Standards, FDA Guidance and Regulations, and Animal Welfare Regulations., • Experience with surgical publication submission strategy is strongly preferred., • Strong communication skills (both written and verbal) is required with the ability to extract key facts from complex information and present concise summaries to management., • Demonstrated experience with large animal in vivo surgical research and CRO vendor management is required., • Previous experience in authoring and reviewing nonclinical regulatory documents as well as interactions with regulatory authorities is strongly preferred., • Excellent problem solving, conflict resolution, and analytical skills is required., • Ability to work effectively both independently and collaboratively in a dynamic team-oriented environment is required., • Prior experience and ability to work well with external CROs and collaborators with professionalism and discretion is required., • Requires strong leadership and organizational skills including attention to detail and multi-tasking skills., • Able to understand and execute to project details but keep overall “big picture” view of projects, priorities, and strategies is required., • Medical Device product development experience, including knowledge of medical device regulations, regulatory/notified body requirements is preferred., • Good Laboratory Practices (GLP) experience preferred and working knowledge of Good Manufacturing Practices (GMP), • Experience in developing and commercializing regulated devices under Design Control (21 CFR 820) requirements, GLP/GMP, and ISO regulations is preferred., • Hands-on research experience with hemostatic devices and/or coagulation chemistry, strongly preferred., • Legal authorization to work in the United States., • This position is located in Brooklyn, NY and may require up to 30% travel (to monitor and execute out-sourced studies) Cresilon is an equal-opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits • Competitive annual base salary range of $130,000 - $210,000, depending upon job level and qualifications., • Paid Vacation, Sick, & Holidays, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage, • Company Paid Life and Short-Term Disability Coverage, • Work/Life Employee Assistance Program, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . The Production Technician I is responsible for the aseptic manufacturing of Cresilon’s products for the animal health industry. The Production Technician II will be trained in clean room operations, aseptic techniques, and must demonstrate the ability to successfully pass gowning qualifications. The position involves operating simple and complex processing equipment, routine sanitization of cleanroom facilities, and manual cleaning of equipment. The ideal candidate will have a proven track record of steady progress in a similar manufacturing environment and must possess a willingness to learn all equipment and jobs in the assigned manufacturing and sanitation of clean room facilities as required. Production Technicians are also responsible for the quality of products produced by ensuring compliance with local, State and Federal regulations, including current Good Manufacturing Practices (cGMP). • Perform line clearance of assigned production areas as required., • Perform equipment set up and disassembly activities., • Operate production, assembly and testing equipment, including heat sealers, bar code scanners, weighing scales, tumblers, autoclaves, filling equipment, and packaging equipment., • Formulate, fill, and pouch product in accordance with SOPs., • Troubleshoot all operating deviations and issues and coordinate with other functions when required., • Report both machine and operating deviations to area supervisor or designee., • Perform routine, preventative maintenance on equipment., • Perform cleaning and disinfection of the manufacturing spaces., • Perform cleaning and sterilization of manufacturing equipment., • Perform visual inspection of components and/or product in accordance with SOP’s and cGMP’s., • Perform sampling, intermediate, and finished goods packaging as per SOPs., • Package and ship raw materials for sterilization., • Perform material receiving, staging, material movements, and material replenishment as per SOPs., • Transport samples, materials, and equipment between multiple facilities., • Complete data entry and generate reports for material inventory movements., • Complete and maintain applicable logbooks and batch record paperwork as required and in accordance with GMP and GDP standards., • Maintain a clean production environment during shift., • Report all actual, near misses and potential accidents for further investigation., • Take immediate action to resolve any near miss situations., • Assist in investigation of all actual, near misses and potential accidents. Provide information to troubleshoot and take initiative to resolve operational issues independently., • Assist in project commissioning and validation activities, as necessary., • Prepare samples or prototypes as required for testing, or other evaluations, • Monitor the plant status and liaise with colleagues of other departments to ensure there is no interruption to manufacturing process., • Complete all required trainings: Read and Understand (TM1), Computer Based Training with Quiz (TM2), Instructor Led (TM3/TM4), and On-the-Job Trainings (TM5)., • Oversee training of junior employees on production processes as assigned., • Ensure proper communication and handling over of shift duties., • Support Environmental and Personnel Monitoring (EM/PM) activities as directed., • HS Diploma or Equivalent with 2+ years of relevant manufacturing experience in the pharmaceutical, biotechnology, or medical device industry OR 2 or 4 year degree with 0+ years of relevant experience., • Ability to read, understand, and execute written work instructions., • Ability to complete documentation accurately., • Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals, • Ability to become gowning qualified to work in a cleanroom environment., • Ability to problem solve and achieve business objectives., • Ability to adapt training approach., • Willingness to be flexible, and open minded to new processes or changes in direction., • Team oriented, building relationships with peers and managers in a proactive manner., • Excellent verbal and written communication skills., • Proficient in Microsoft Office (Word, Excel, Outlook)., • Paid Vacation, Sick, & Holidays, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage, • Company Paid Life and Short-Term Disability Coverage, • Work/Life Employee Assistance Program, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Monthly MetroCard Reimbursement This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Job Description Blue Matter is a rapidly growing management consultancy focused primarily in the biopharmaceutical industry. We partner with our clients to help them achieve commercial success across the lifecycle of their products, portfolios and organizations. Our project types include new product planning, launch strategy, portfolio planning, disease area strategy and organizational strategy. The majority of our work is in specialty therapeutics, including areas such as oncology, immunology, and rare disease. Our commercial planning also spans diverse care settings with distinct market access dynamics. As a Manager with Blue Matter, you will join a startup firm with a dynamic and growing team of seasoned consultants, and have the opportunity to help grow and build the company. You will work collaboratively with senior internal and client team members to address critical business issues in biotechnology and pharmaceuticals, and deliver value through providing innovative and actionable solutions to our clients. Primary Responsibilities • Manage project teams in the delivery of cross-functional projects across multiple areas of expertise, including product commercialization and launch, portfolio and product strategy, and organizational strategy and excellence, • Support project leadership in the development of project objectives; develop and manage project plans, • Identify required project tasks, assist project leads in assigning tasks to team members, and demonstrate accountability for ensuring task completion, • Design, execute, analyze and synthesize primary and secondary research efforts, • Identify key insights, recommendations, opportunities, and threats to inform corporate and commercial strategies, • Regularly engage senior-level clients, • Recruit, develop and manage top talent, • Demonstrated expertise and experience in new product commercialization, product launch, product strategy, and organizational strategy and excellence, • Demonstrated expertise in supporting the development of effective U.S. market access strategies:, • Demonstrated subject matter expertise in the areas of U.S. Coverage, Coding, Payment, and Pricing, • Experience in / understanding of key market access decision makers, including organized customers and pathway decision makers., • Experience in / understanding of evidence needs to support market access and pricing, • Experience in / understanding of evolving healthcare policy and the impact on access, • Demonstrated subject matter expertise in both the medical and pharmacy benefit across all major US payer segments (e.g., Commercial, Medicare, Medicaid, and Federal Markets), • Demonstrated knowledge of reimbursement methodologies across core sites of care, including physician offices / clinics, hospital outpatient departments, hospital inpatient, and long-term care settings, • Prior experience in both medical benefit and pharmacy benefit specialty therapeutic areas, • Prior experience fielding primary market research initiatives in support of commercial strategy campaigns, • Demonstrated ability to lead multiple workstreams across matrixed teams, • Strong analytical and problem-solving skills, • Advanced degree(s) (PhD, MD, MBA, MPH, JD, or MS), • 4+ years of life sciences consulting experience or comparable biopharma industry experienceCompensation: Base salary range: $160,000 - $175,000 depending on experience. Generous incentive compensation structure. Benefits Package: • 401k - generous employer match with immediate vesting and financial planning resources, • Comprehensive medical, dental and vision coverage options effective day 1 of employment, • Flexible spending account (FSA) or Health Savings Account (HSA), • Company paid insurances including Short- and Long-Term Disability and Life insurance as well as additional voluntary options, • Paid parental leave for all new parents, • Health & Wellness Benefit (e.g., gym memberships; $1000 reimbursement annually), • Employee Assistance Program Xy8h24HDkb

Job DescriptionWe are seeking a Remote Sales Account Executive to accelerate growth and expand market presence for our client, a leader in the DNA sequencing industry. This role is ideal for a driven sales professional with deep domain knowledge in sequencing technologies and a passion for empowering scientists to achieve breakthroughs. As a Sales Account Executive, you will be responsible for driving new business, managing key accounts, and building long-term relationships with customers across biotech, academia, and government sectors. This is a high-impact role with strong visibility and significant growth potential. What You’ll Do * Drive revenue growth by identifying, pursuing, and closing new business opportunities. * Manage and expand existing client relationships, ensuring high levels of satisfaction and retention. * Use a consultative sales approach to position solutions for customers in sequencing, synthetic biology, cell & gene therapy, and molecular biology. * Partner with internal teams and stakeholders to design and deliver strategies that achieve measurable results. * Maintain accurate and organized pipelines, tasks, and activities using CRM tools such as Salesforce or HubSpot. * Represent the company at conferences, seminars, and client meetings within your territory (with occasional travel outside of it). What We’re Looking For * 5+ years of experience in sequencing sales or related life sciences technology sales. * Proven success in exceeding revenue targets and growing accounts. * Familiarity with sequencing workflows, synthetic biology, molecular biology, and related applications. * Experience selling to academic, biotech, and government customers. * Strong consultative selling skills, with a history of developing strategies that drive impactful outcomes. * Excellent communication, negotiation, and presentation skills, with the ability to influence decision-makers. * Strong CRM proficiency (Salesforce, HubSpot, or similar). * A Bachelor’s degree in Biology, Biotechnology, Life Sciences, or a related field. * Self-motivated, results-driven, and able to thrive in a dynamic, fast-paced environment. Why This Role? * Competitive compensation package with strong upside. • Fully Remote with full flexibility Opportunity to sell industry-defining solutions in a high-growth market. * Direct visibility with leadership and the ability to shape best practices as the sales team scales. * Equity upside in a bootstrapped, rapidly growing company.

Job DescriptionQuality Control Analytical ScientistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The QC Analytical Scientist will be a member of the Quality Control Department. As a Senior Member of the team the QC Analytical Scientist will be involved in various QC projects and should have a deep understanding of general QC flow and the Product Cycle. • Support internal and external customers to ensure that proper and timely execution of all aspects of the clinical analytical method life cycle across clients., • Support routine GMP testing as assigned. Mentor and train team members, • Evaluate corporate and regulatory requirements along with coordination of activities for implementation of these requirements., • Write the contents of Analytical Method Transfer and Validation life cycle documentation including master plans, protocols, test methods, and reports., • Create validation project plan i.e., timelines and resources and provides status updates to management. Utilize statistical tools for evaluation of method validation and trending data., • Identify, evaluate, and implement continuous business process improvements., • Perform troubleshooting activities with respect to methods/assays, equipment malfunctions and investigations (Deviations and OOS)., • Provide support during laboratory investigations., • Train QC personnel during method transfer and validation. Provide support during equipment qualification., • Consistently produce elevated level of documentation accuracy and clarity according to cGMP documentation practices., • Ability to set deadlines and prioritize work for self, group members, and support groups involved. Ability to review/approve work performed by coworkers for accuracy and alignment with procedures., • Indirectly may supervise cross functional teams including product development, QA, PMP, and Manufacturing.REQUIREMENT, • B.S Analytical Chemistry or other scientific field or MS/Ph.D. in Analytical Chemistry or other scientific field with demonstrated experience in Quality Control laboratories for biotechnology products., • 8-10 years of experience in the areas of method development, validation, and transfer., • Direct GMP Experience., • Proficiency in project management skills and tools., • Strong background and in-depth knowledge in analytical chemistry e.g. Flow Cytometry, ELISA, HPLC, CE, PCR, etc., • Extensive knowledge and experience of QC assay development, transfer and validation, along with cGMPs., • Strong Quality orientation with attention to detail required. Analytical and problem-solving skills required., • Excellent communication skills, both written and verbal, with all levels of the organization, including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution., • Excellent presentation skills. Ability to communicate to upper management, across departments and within the immediate QC team., • Ability to create and manage work plans and timelines and independently manage competing priorities with limited instruction., • Highly motivated individual with good interpersonal skills that have proven effective in managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external., • Must be familiar with GMP lab environment and Aseptic techniques.Working EnvironmentMust have the ability to work in a team-oriented environment and with clientsMust be able to work during the weekend, holidays, or overtime and as required by the companyMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogenMust have the ability to work with specialized equipmentMust be able to handle the standard/moderate noise of the manufacturing facilityMay work with hazardous materials and chemicals Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Blue Matter is a rapidly growing management consultancy focused primarily in the biopharmaceutical industry. We partner with our clients to help them achieve commercial success across the lifecycle of their products and portfolios. Our project types include new product planning, launch strategy, portfolio planning and disease area strategy. The majority of our work is in specialty therapeutics, with oncology and rare diseases as specific areas of expertise. We have a unique entrepreneurial culture and invest in building Blue Matter to be one of the the best places to work. We have a strong global presence with offices in the US (San Francisco, New York, and Boston), Europe (London, Zurich, Netherlands), and India. As a Senior Consultant with Blue Matter, you will join a startup firm with a dynamic and growing team of seasoned consultants, and have the opportunity to help grow and build the company. You will work collaboratively with senior internal and client team members to address critical business issues in biotechnology and pharmaceuticals, and deliver value through providing innovative and actionable solutions to our clients. Primary Responsibilities • Execute on assigned project tasks, • Prepare materials for project meetings, • Execute analysis of primary and secondary research efforts, • Create and utilize analytical tools to support decision making, • Develop materials communicating results of analyses, • Identify key insights, recommendations, opportunities, and threats to inform corporate and commercial strategies, • Demonstrate accountability for completion of project responsibilities, • Understanding of the pharmaceutical and biotechnology industries with a focus on market access related roles (i.e. pricing, contracting, market access analytics, payer mix analysis, provider mix analysis, specialty pharmacy and IDN dynamics, patient services and patient access), • Demonstrated ability to integrate business and industry knowledge in developing creative solutions, • Strong analytical and problem solving skills, • Excellent written and oral communication skills, • Solid time management skills, • Demonstrated ability to work in team environment, • Advanced degree(s) (PhD, MD, MBA, or MS) with 2+ years of consulting experience or, • Undergrad degree with 3+ years of consulting experience or, • 3+ years of biopharma industry experienceCompensation: Base salary range: $140,000 - $160,000 depending on experience. Generous incentive compensation structure. Benefits Package: • 401k - generous employer match with immediate vesting and financial planning resources, • Comprehensive medical, dental and vision coverage options effective day 1 of employment, • Flexible spending account (FSA) or Health Savings Account (HSA), • Company paid insurances including Short- and Long-Term Disability and Life insurance as well as additional voluntary options, • Paid parental leave for all new parents, • Health & Wellness Benefit (e.g., gym memberships; $1000 reimbursement annually), • Employee Assistance Program 5kIQjTBZdW

Job Description Blue Matter is a rapidly growing management consultancy focused primarily in the biopharmaceutical industry. We partner with our clients to help them achieve commercial success across the lifecycle of their products and portfolios. Our project types include new product planning, launch strategy, portfolio planning and disease area strategy. The majority of our work is in specialty therapeutics, with oncology and rare diseases as specific areas of expertise. We have a unique entrepreneurial culture and invest in building Blue Matter to be one of the the best places to work. We have a strong global presence with offices in the US (San Francisco, New York, and Boston), Europe (London, Zurich, Netherlands), and India. As a Consultant with Blue Matter, you will join a startup firm with a dynamic and growing team of seasoned consultants, and have the opportunity to help grow and build the company. You will work collaboratively with senior internal and client team members to address critical business issues in biotechnology and pharmaceuticals, and deliver value through providing innovative and actionable solutions to our clients. Primary Responsibilities • Execute on assigned project tasks, • Prepare materials for project meetings, • Execute analysis of primary and secondary research efforts, • Create and utilize analytical tools to support decision making, • Develop materials communicating results of analyses, • Identify key insights, recommendations, opportunities, and threats to inform corporate and commercial strategies, • Demonstrate accountability for completion of project responsibilities, • Understanding of the pharmaceutical and biotechnology industries with a focus on market access related roles (i.e. pricing, contracting, market access analytics, payer mix analysis, provider mix analysis, specialty pharmacy and IDN dynamics, patient services and patient access), • Demonstrated ability to integrate business and industry knowledge in developing creative solutions, • Strong analytical and problem solving skills, • Excellent written and oral communication skills, • Solid time management skills, • Demonstrated ability to work in team environment, • Advanced degree(s) (PhD, MD, MBA, or MS) with 1+ years of consulting experience or, • Undergrad degree with 2+ years of consulting experience or, • 2+ years of biopharma industry experienceCompensation: Base salary range: $110,000 - $140,000 depending on experience. Generous incentive compensation structure. Benefits Package: • 401k - generous employer match with immediate vesting and financial planning resources, • Comprehensive medical, dental and vision coverage options effective day 1 of employment, • Flexible spending account (FSA) or Health Savings Account (HSA), • Company paid insurances including Short- and Long-Term Disability and Life insurance as well as additional voluntary options, • Paid parental leave for all new parents, • Health & Wellness Benefit (e.g., gym memberships; $1000 reimbursement annually), • Employee Assistance Program hSy6oWc9zB

Job DescriptionSalary: 100,000 - 150,000 Tang Capital Management, LLC (Tang Capital) is a life sciences-focused investment firm with offices in San Diego and New York. Position Summary Tang Capital is seeking an entry level Biotechnology Research Analyst to work in its New York office. The Biotechnology Research Analyst is responsible for fundamental scientific research and financial analysis on biotechnology stocks and drugs across a wide range of diseases to support Tang Capitals existing and future portfolio companies. This involves analyzing and interpreting complex medical, scientific and technical data to produce compelling and concise written deliverables and presentations. The Biotechnology Research Analyst will have an opportunity to gain experience in investment research and analysis as well as a unique opportunity to gain operational experience in hands-on drug development through Tang Capital affiliates. Qualifications Bachelors or advanced degree in life sciences, chemistry or medicine required Exceptional academic track record Strong work ethic, high integrity, willingness to tackle any challenge and a tenacious desire to learn Strong organizational, quantitative, verbal, writing and editing skills with rigorous attention to detail and the ability to communicate directly and concisely Ability to adapt and thrive in a rapidly changing and high performance environment Tang Capital is an Equal Opportunity Employer. Tang Capital participates in the E-verify program. If you need assistance or an accommodation due to a disability, please contact us at .

At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us! Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA. Job Description This position will be responsible for successful delivery of client programs for pharmaceutical, biotechnology and/or healthcare clients. The Engagement Manager is responsible for supporting the Associate Principal’s and Principal’s in coordinating efforts between customers, operations, medical and analytics teams and to enhance existing services business operations to generate new lines of business through custom data deliverables, consulting practices and new product development. EVERSANA™ is the leading provider of global commercial services to the life sciences industry. Our integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. We serve more than 500 organizations, including innovative start-ups and established pharmaceutical companies to advance life science solutions for a healthier world. We have built a comprehensive integrated commercial services platform, powered by more than 7,000 employees, to bring innovative products to the market, reducing cost and risk while simultaneously improving outcomes. We are fast becoming a partner of choice for launches ranging from the largest pharmaceutical companies to the latest emerging biotech organizations. EVERSANA Data & Analytics team applies advanced analytics and AI/machine learning techniques to the breadth of healthcare and non-healthcare data integrated with our deep clinical expertise to provide a unique and unmatched suite of services and products to the pharmaceutical and healthcare industries • Leadership of commercial analytics engagement teams and client relationships, • Plan, organize and lead engagement teams to develop logical and insightful analyses, innovative and effective recommendations., • Working closely with the Offshore team, deliver well-structured, high-quality deliverables on a timely manner to realize high levels of client satisfaction., • Take an active role in building client relationships and identifying new business opportunities with clients., • Lead development of proposals for new projects / commercial opportunities in partnership with Principals and/or Senior Principals, • Hire, coach, and develop staff members., • Play an active role in data & analytics practice development and develop practice level intellectual capital., • Take responsibility in development and management of external relationships (e.g., client, vendors, external experts), • Recruit new team members; manage and coach junior team members and serve as a subject matter expert and thought partner to colleagues., • Develop broader and deeper knowledge of consulting methodologies and the pharmaceutical market through on-the-job exposure and formal training., • Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias., • All other duties as assigned. Expectations Of The Job • Travel – Less than 10%, • Hours – 40 hours per week, Monday - Friday The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position. An individual in this position must be able to successfully perform the expectations listed above. Qualifications MINIMUM KNOWLEDGE, SKILLS AND ABILITIES: The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required. • Undergraduate degree from a top-tier institution with a relevant concentration (e.g., computer science, statistics, economics, operations research) and strong academic record, • 6+ years in a Commercial Analytics or Healthcare consulting capacity with an in-depth knowledge of medical and Rx claims datasets and the application of this information in support of commercial and medical engagements., • Provide leadership of commercial analytics teams and client relationships, • Plan, organize and lead engagement teams to develop logical and insightful analyses, innovative and effective recommendations., • Work closely with the Offshore team, deliver well-structured, high-quality deliverables in a timely manner to realize high levels of client satisfaction., • Take an active role in building client relationships and identifying new business opportunities with clients., • Lead development of proposals for new projects / commercial opportunities in partnership with Principals and/or Senior Principals, • Play an active role in data & analytics practice development and develop practice level intellectual capital., • Take responsibility in development and management of external relationships (e.g., client, vendors, external experts), • Recruit new team members; manage and coach junior team members and serve as a subject matter expert and thought partner to colleagues., • Develop broader and deeper knowledge of consulting methodologies and the pharmaceutical market through on-the-job exposure and formal training., • Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias. Preferred Qualifications • Advanced degree(s) (e.g., MBA, PhD, MD) with a relevant concentration (e.g., computer science, statistics, economics, operations research) and strong academic record, • 8+ years of experience in data and analytics with direct experience working with Patient Level data, Hub/CRM data, Market Access data, with knowledge of cloud-based storage, Tableau, and other data visualization software., • Experience at a top global management consulting firm, • Expertise in using analytics and visualization tools (e.g. Python, R, Alteryx, SAS, Tableau, MicroStrategy) and advanced proficiency in Microsoft Excel and PowerPoint Physical/Mental Demands And Working Environment The physical and mental requirements along with the work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position. Office: While performing the essential functions of this job the employee is frequently required to reach, grasp, stand and/or sit for long periods of time (up to 90% of the shift), walk, talk and hear; occasionally required to lift and/or move up to 25 pounds. The noise level in the work environment is usually moderately quiet, with frequent interruptions and multiple demands. Additional Information OUR CULTURAL BELIEFS: Patient Minded I act with the patient’s best interest in mind. Client Delight I own every client experience and its impact on results. Take Action I am empowered and hold myself accountable. Embrace Diversity I create an environment of awareness and respect. Grow Talent I own my development and invest in the development of others. Win Together I passionately connect with anyone, anywhere, anytime to achieve results. Communication Matters I speak up to create transparent, thoughtful, and timely dialogue. Always Innovate I am bold and creative in everything I do. EVERSANA is committed to providing competitive salaries and benefits for all employees. The anticipated base salary range for this position is $145,00 to $200,000 and is not applicable to locations outside of the U.S. The base salary range represents the low and high end of the salary range for this position. Compensation will be determined based on relevant experience, other job-related qualifications/skills, and geographic location (to account for comparative cost of living). EVERSANA reserves the right to modify this base salary range at any time. All your information will be kept confidential according to EEO guidelines. Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA. From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility. Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability, unless such accommodation would cause an undue hardship for EVERSANA. The policy regarding requests for reasonable accommodations applies to all aspects of the hiring process. If reasonable accommodation is needed to participate in the interview and hiring process, please contact us at . Follow us on ___ | ___At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us! Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA. Job Description This position will be responsible for successful delivery of client programs for pharmaceutical, biotechnology and/or healthcare clients. The Engagement Manager is responsible for supporting the Associate Principal’s and Principal’s in coordinating efforts between customers, operations, medical and analytics teams and to enhance existing services business operations to generate new lines of business through custom data deliverables, consulting practices and new product development. EVERSANA™ is the leading provider of global commercial services to the life sciences industry. Our integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. We serve more than 500 organizations, including innovative start-ups and established pharmaceutical companies to advance life science solutions for a healthier world. We have built a comprehensive integrated commercial services platform, powered by more than 7,000 employees, to bring innovative products to the market, reducing cost and risk while simultaneously improving outcomes. We are fast becoming a partner of choice for launches ranging from the largest pharmaceutical companies to the latest emerging biotech organizations. EVERSANA Data & Analytics team applies advanced analytics and AI/machine learning techniques to the breadth of healthcare and non-healthcare data integrated with our deep clinical expertise to provide a unique and unmatched suite of services and products to the pharmaceutical and healthcare industries • Leadership of commercial analytics engagement teams and client relationships, • Plan, organize and lead engagement teams to develop logical and insightful analyses, innovative and effective recommendations., • Working closely with the Offshore team, deliver well-structured, high-quality deliverables on a timely manner to realize high levels of client satisfaction., • Take an active role in building client relationships and identifying new business opportunities with clients., • Lead development of proposals for new projects / commercial opportunities in partnership with Principals and/or Senior Principals, • Hire, coach, and develop staff members., • Play an active role in data & analytics practice development and develop practice level intellectual capital., • Take responsibility in development and management of external relationships (e.g., client, vendors, external experts), • Recruit new team members; manage and coach junior team members and serve as a subject matter expert and thought partner to colleagues., • Develop broader and deeper knowledge of consulting methodologies and the pharmaceutical market through on-the-job exposure and formal training., • Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias., • All other duties as assigned. Expectations Of The Job • Travel – Less than 10%, • Hours – 40 hours per week, Monday - Friday The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position. An individual in this position must be able to successfully perform the expectations listed above. Qualifications MINIMUM KNOWLEDGE, SKILLS AND ABILITIES: The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required. • Undergraduate degree from a top-tier institution with a relevant concentration (e.g., computer science, statistics, economics, operations research) and strong academic record, • 6+ years in a Commercial Analytics or Healthcare consulting capacity with an in-depth knowledge of medical and Rx claims datasets and the application of this information in support of commercial and medical engagements., • Provide leadership of commercial analytics teams and client relationships, • Plan, organize and lead engagement teams to develop logical and insightful analyses, innovative and effective recommendations., • Work closely with the Offshore team, deliver well-structured, high-quality deliverables in a timely manner to realize high levels of client satisfaction., • Take an active role in building client relationships and identifying new business opportunities with clients., • Lead development of proposals for new projects / commercial opportunities in partnership with Principals and/or Senior Principals, • Play an active role in data & analytics practice development and develop practice level intellectual capital., • Take responsibility in development and management of external relationships (e.g., client, vendors, external experts), • Recruit new team members; manage and coach junior team members and serve as a subject matter expert and thought partner to colleagues., • Develop broader and deeper knowledge of consulting methodologies and the pharmaceutical market through on-the-job exposure and formal training., • Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias. Preferred Qualifications • Advanced degree(s) (e.g., MBA, PhD, MD) with a relevant concentration (e.g., computer science, statistics, economics, operations research) and strong academic record, • 8+ years of experience in data and analytics with direct experience working with Patient Level data, Hub/CRM data, Market Access data, with knowledge of cloud-based storage, Tableau, and other data visualization software., • Experience at a top global management consulting firm, • Expertise in using analytics and visualization tools (e.g. Python, R, Alteryx, SAS, Tableau, MicroStrategy) and advanced proficiency in Microsoft Excel and PowerPoint Physical/Mental Demands And Working Environment The physical and mental requirements along with the work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position. Office: While performing the essential functions of this job the employee is frequently required to reach, grasp, stand and/or sit for long periods of time (up to 90% of the shift), walk, talk and hear; occasionally required to lift and/or move up to 25 pounds. The noise level in the work environment is usually moderately quiet, with frequent interruptions and multiple demands. Additional Information OUR CULTURAL BELIEFS: Patient Minded I act with the patient’s best interest in mind. Client Delight I own every client experience and its impact on results. Take Action I am empowered and hold myself accountable. Embrace Diversity I create an environment of awareness and respect. Grow Talent I own my development and invest in the development of others. Win Together I passionately connect with anyone, anywhere, anytime to achieve results. Communication Matters I speak up to create transparent, thoughtful, and timely dialogue. Always Innovate I am bold and creative in everything I do. EVERSANA is committed to providing competitive salaries and benefits for all employees. The anticipated base salary range for this position is $145,00 to $200,000 and is not applicable to locations outside of the U.S. The base salary range represents the low and high end of the salary range for this position. Compensation will be determined based on relevant experience, other job-related qualifications/skills, and geographic location (to account for comparative cost of living). EVERSANA reserves the right to modify this base salary range at any time. All your information will be kept confidential according to EEO guidelines. Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA. From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility. Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability, unless such accommodation would cause an undue hardship for EVERSANA. The policy regarding requests for reasonable accommodations applies to all aspects of the hiring process. If reasonable accommodation is needed to participate in the interview and hiring process, please contact us at . Follow us on |

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job Overview: The Senior Director, Clinical Safety and Pharmacovigilance plays a key leadership role in driving our patient safety and shaping risk management strategies across global clinical development. This position offers the opportunity to champion pharmacovigilance excellence, proactively manage safety signals, and steer impactful medical monitoring in an innovative, science-led environment. Location: Remote on the East Coast, United States or United Kingdom (or hybrid in our NYC or London office). Reports to: Vice President, Clinical Safety and Pharmacovigilance. Roles and responsibilities (Include but are not limited to): • Serve as drug safety SME for Compass clinical development programs and as primary Sponsors medical contact or medical monitor for assigned Phase 1-3 studies, • Lead safety activities, benefit-risk strategies, and safety signal management for assigned studies and compounds, • Oversee aggregate safety review documents, safety labelling, and safety sections of clinical trial documents and regulatory filings, ensuring compliance with global regulations, • Oversee and manage vendors/CROs supporting Safety/PV functions, • Identify, evaluate, and manage safety signals through comprehensive data analysis author safety signal assessments and aggregate reports, • Prepare, coordinate, and submit safety reports (PSURs, DSURs, CIOMS, etc.) to regulatory authorities ensure ongoing compliance with local and international regulations, • Develop, maintain, and provide training on SOPs, PV processes, and procedures in accordance with Good Pharmacovigilance Practices (GVP), • Collaborate with cross-functional teams (clinical operations, regulatory affairs, medical affairs) to address safety issues and develop effective risk minimization strategies, • Manage and develop PV scientists and mentor/supervise colleagues as positive change agents, • Represent Compass at Health Authority inspections, DMC meetings, and provide input to R&D publication strategy, • Maintain thorough and accurate documentation of safety data, supporting timely and quality submissions and presentations, • Ensure all responsibilities are performed efficiently, accurately, and cost-effectively in line with current global regulatory and quality standards, • Accountable for compliance with ethical and scientific standards, regulatory requirements, and the Compass Quality Management System, ensuring participant safety, data integrity, and accuracy throughout the trial process, • MD/DO/MBBS required with considerable experience in the pharmaceutical industry, predominantly in the drug safety/medical monitoring function track record of successful product launch, • Extensive industry experience in CNS, ideally psychiatry, • Demonstrated working knowledge of cGCP, ICH, and other relevant clinical development EU/US regulations and processes, • Experience/in-depth understanding of clinical trial/drug development from a regulatory perspective, • Excellent written and oral English communication and presentation skills and interpersonal skills to engage internal and external leaders proactively, • Proven ability to work effectively on a team in a collaborative environment Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$260,000—$320,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job DescriptionCompliance Investigator, Clinical ManufacturingAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Compliance Investigator, Clinical Manufacturing leads life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools., • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approach., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process., • Champion CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS degree in a Quality/ Process related field., • Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology or Bio-Pharma., • Root cause analysis experience in pharmaceutical or FDA regulated operation preferred., • Experience using e-Quality Management Systems preferred., • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Flexible and able to adapt to company growth and evolving responsibilities, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • Ability to work effectively as a team and independently., • Quality Systems Training (Deviation/CAPA)Working Environment While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryo-gloves must be used when working with liquid nitrogen. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionQC Analytical Compliance Investigator Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. Our client is seeking a QC Analytical Compliance Investigator to lead life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools., • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approach., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process., • Champion CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS in a Quality / Process related field., • Experience in GMP Operations and/or QA in Cell Therapies, Biotechnology or Bio-Pharma., • Root cause analysis experience in pharmaceutical or FDA regulated operation preferred., • Experience using e-Quality Management Systems preferred., • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Flexible and able to adapt to company growth and evolving responsibilities, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • Ability to work effectively as a team and independently., • GMP Trained, Quality Systems Trained (Deviation/CAPA)Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Physical RequirementsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryo-gloves must be used when working with liquid nitrogen. Other DutiesPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description MAJOR RESPONSIBILITIES: • Meet or Exceed Revenue Goals for defined geography and book of business., • Grow large existing customer book of business, increase number of clients., • Increase Baylor Genetics volume within Hospital System customers; identify additional revenue sources., • Apply product and services knowledge across the genetic analysis portfolio to develop strategic selling presentations to professional audiences (physicians, genetic counselors, laboratory staff)., • Develop and implement a comprehensive business plan to meet or exceed sales goals by presenting new test information, upselling and seeking out new sources of revenue., • Develop and maintain deep knowledge of market space, technical and clinical environment, competitor presence, and client behaviors required to compete in assigned territory., • Align with internal business partners and product management to discover, drive, and close sales opportunities related to NICU/PICU/Pediatrics business and new client segments., • Communicate customer insights, market trends & competitive data and to leadership and peers., • Leverage Medical Science Liaison and other Company resources to provide technical, clinical and business content to deliver solutions that meet or exceed customer expectations., • Uphold company mission and values; ensure compliance in all company policies and guidelines. Travel within assigned territory is required to meet with customers and potential customers. * Some travel outside of the assigned territory is required to support conferences and attend sales meetings, trainings, and company events. • Partner with Market Access to develop system-wide access strategies and payor advocacy., • Educate and train BG clients and prospects, in a defined territory, on BG genomics testing menu., • Able to present clinical information to clinicians and staff in the NICU/PICU/Pediatric Genetics space., • Experience with NGS, molecular diagnostics, or genetics is required., • Bachelors in Life Science, Biology, Business or Marketing is ideal., • 5+ years of direct experience in a customer-facing sales role in a medical, healthcare or technical field with a history of 1) consistent closing abilities throughout the sales cycle and 2) proven past performance that has met and exceeded expectations., • Computer proficiency in MS Office, email, internet and CRM (Salesforce.com or equivalent). PREFERRED QUALIFICATIONS • Proven Experience selling products or services directly to hospitals, Genetic Counselors, and Clinicians specializing in Pediatric Genetics., • Demonstrated sales success at either a diagnostic or relevant biotechnology company., • Experience using/coaching to different sales methodology (Challenger, SPIN, etc.)., • Understanding of NICU/PICU, pediatric genetics environment and their buying motivations., • Proven Experience promoting products or services directly to hospitals/health systems., • Solid analytical, organizational, problem solving, communication and presentation skills required. EEOC Statement Baylor Genetics is proud to be an equal opportunity employer dedicated to building an inclusive and diverse workforce. We do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, gender identity, veteran status, disability, genetic information, pregnancy, childbirth, or related medical conditions, or

Job DescriptionQuality Control Microbiology SupervisorAllendale, NJ The Quality Control Microbiology Supervisor organizes, and directs staff to meet and exceed cGMP requirements, establish KPI’s, while adhering to quality control-microbiological and technical standards. Provides oversight of day to day activities including adjustment of workflow, test performance, and quality compliance. • Team Leadership - Interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. Directly supervised the following roles: QC Microbiology Associates, • Investigate and document non-confirming events and environmental excursions., • Troubleshoot and recommend process improvements to achieve greater efficiency ad meet quality goals., • Interact with other Microbiology departments on a regularly scheduled basis to discuss and harmonize best practices, procedures and processes between the sites., • Participate in department and cross functional meetings., • Ensure compliance with regulatory agency requirements by enforcing a quality culture throughout the department., • Interact with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns., • Author and revise Standard Operating Procedures, Work Instructions, forms and Protocols to reflect current practices., • Perform microbiological and environmental monitoring data review. Compile and issue quarterly and annual Environmental Monitoring trending reports., • Provide staff development through feedback aimed towards performance development and review., • Ability to remain focused and effective in high stress situations., • Builds constructive working relationships characterized by a high level of acceptance, cooperation, and mutual respect., • Able to handle challenging interpersonal relationships., • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws., • Aseptic Processing StandardsREQUIREMENTS, • BS in Microbiology or relevant field required., • Biotechnology Certificate and/or cGMP experience, • Minimum of 3 years of experience with environmental monitoring or within the biopharmaceutical industry., • Strong knowledge of microbiological test methods, philosophies, method validation and method transfer., • Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review., • Proficient with computer software with MS Office, Excel, and MODA., • Must have ability to work in a team-oriented environment and with vendors., • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen, • Must have the ability to work in the cleanroom environment for extended period of time, • Must have the ability to work with specialized equipment, • Must be able to handle the standard/moderate noise of the manufacturing facility, • The employee must be able to comply with personal hygiene standards as they apply to aseptic processing. The employee must successfully complete sterile gowning training/qualification and aseptic process qualification (personal media fill) as well as annual/semiannual re-qualification as a core competency requirement of their employment in this role., • An individual may exert up to 10 pounds of force occasionally or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects., • Must be physically capable to stand, walk, sit, bend, stretch, use hands to handle or feel, reach with hands and arms, and talk or hear., • The employee is frequently required to lift and/or move up to 30 pounds and occasionally move tanks up to 300 pounds (with assistance), • Heavy cryo-gloves must be used when working with liquid nitrogen, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noise.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionAssociate Director, Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Associate Director, Manufacturing Operations is responsible for efficient utilization of Operations resources to meet customer demand. This role will be responsible for maintaining and overseeing the site Operations scheduling and training capacities for a time period looking ahead to the next 3-6 months. The Associate Director, Manufacturing Operations will understand upcoming needs and constraints and help drive strategy accordingly. This includes the management of all Operations scheduling, training and compliance resources. The Associate Director, Manufacturing Operations is also responsible for assessing the needs of the company to contribute to the big picture by ensuring daily operations run smoothly and as efficiently as possible. This role will also drive individual and team development to ensure a prepared and empowered workforce to become the provider of choice for the industry. • Meeting client process demands through planning, scheduling, manufacture and delivery of clinical cell therapy products according to established procedures, regulations and contracts, • Looking out 3-6 months to ensure capacity and availability of resources (room/equipment/staff) to perform clinical manufacture for processing needs, • Manages all training and compliance activities in the Operations organization, • Responsible for creating, enforcing and measuring Operator training schedules in order to ensure that all production schedules can be carried out, • Creates and maintains a process to ensure that personnel schedules are being accurately and fairly assigned to all Associates, • Supporting and driving special long-term projects and identified and assigned by the PPU Head, • Responsible for creating maintaining and communicating all Operations based KPI’s, • Ensuring department staff compliance with corporate and site-specific HR policies, safety, and business policies and practices, • Approving job specific curriculum for the training and professional development of department staff, • Responsible for streamlining the batch record review process, • Responsible to understand the profit and loss for the PPU’s as well as all related documentation, and how these items impact Operations, • Driving continuous improvement, • Liaison with support groups for short- and medium-term needs – Supply Chain, Training, Quality Systems, Quality Assurance, Quality Control, and others, • Set team expectations and goals and assists in delivering the business direction for the PPU, • Aligning departmental goals, processes and resource allocation with the organizational strategy, • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws., • Direct reports: Associate Manager Training, Associate Manager, Compliance, Scheduling Associate, Quality Engineer Associates. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. REQUIREMENTS, • Bachelor's degree (i.e. Biology, Biotechnology, Bioengineering, Chemical Engineering)., • 5-10 years of cGMP environment, aseptic processing, mammalian cell culture, monoclonal antibody, cell processing, cryopreservation or similar experience., • 5-10 years of leadership experience or equivalent combination of experience., • Deep Understanding of cGMP and cGLP, • Working knowledge of financial operations and budget development, • Relevant IT skills (able to work with Microsoft Office and corporate scheduling system), • Competencies/Candidate Profile, • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Flexible and able to adapt to company growth and evolving responsibilities, • Accountability, integrity, and strong dedication to regulatory compliance, • Strong business and personnel management acumen, • Strong emotional intelligence, • Ability to think strategically and tactically (detail-oriented), • Strong analytical and problem-solving skills, • Strong written and verbal communication skills, • Drive to create and maintain order in a fluid, technically complex environment, • Continuous improvement mindset, • Ability to multi-task is essential, • Must have the ability to work in a team-oriented environment and with clients, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.Must be capable of moving, sitting, stretching, stooping, using hands and fingers, reaching with hands and arms, talking and exchanging information, and vision sufficient to read materials.Duties, responsibilities, and activities may change at any time with or without notice

Job DescriptionManager Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Primary Processing Unit (PPU), Manager, Manufacturing Operations is responsible for efficient capacity utilization of site resources to meet customer demand. They will partner with support functions to deliver on customer demands. This leader is accountable for the management of client projects at the site and for delivery of results within project scope, agreed timelines, contract requirements, revenue targets, as well as compliance and regulatory requirements. The Manager, Manufacturing Operations is responsible for profit and loss within their PPU and will deliver on revenue. This role will also drive individual and team development to ensure a prepared and empowered workforce to become the provider of choice for the industry. • Meet client process demands through planning, scheduling, manufacture and delivery., • of clinical cell therapy products according to established procedures, regulations and contract., • Ensures manufacturing documentation is closed out in a timely manner in accordance with applicable regulations and per contract., • Ensures capacity availability of resources (room/equipment/staff) to perform clinical manufacture for clients per contract., • Ensures process hours are charged - tracked to meet contract and revenue targets., • Accountable for maintaining a mechanism to work with clients to troubleshoot problems, suggests improvements and determines & advocates for value-add projects., • Assures manufacturing space is kept in a clean, validated state in compliance with company procedures, GMP and applicable regulations, • Ensures on the job training program and resources for new associate (proficiency) training and cross training of existing staff., • Ensures a safe work environment for employees., • Ensures department staff compliance with corporate and site-specific HR policies, safety and business policies and practice., • Approves job specific curriculum for the training and professional development of department staff., • Holds regular staff and 1:1 meetings to emphasize corporate culture, maintain morale, and provides a forum for staff development and discussion., • Responsible for the profit and loss for the PPU, • Deliver on revenue, • Assures compliance with budget, • Liaison with support groups – supply chain, training, quality systems, and business development, • Partners with clients along with Project Management and team leadership; drives the account management and liaison with the clients, • Sets team expectations and goals and delivers the business direction for the PPU, • Sets KPIs & ROIs targets and assures PPU metrics are maintained and tracked monthly., • Coordinates with PPU leadership and team meetings and determines PPU strategy development, • Accountable for driving the spirit of continuous improvement, • Collaborates with Business Development to ensure compliance and contract requirements, • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Directly supervises the following roles: Associate Manager, Manufacturing, Manufacturing Associates, Lead Manufacturing Associates, Production Support Associates, Technical Trainers, Compliance InvestigatorsREQUIREMENTS, • Bachelor's degree (ie Biology, Biotechnology, Bioengineering, Chemical Engineering)., • 5-7 years of cGMP environment, aseptic processing, mammalian cell culture, cell processing, cryopreservation experience., • 5-7 years of leadership experience or equivalent combination of experience., • Strong business acumen, • Deep understanding of cGMP and cGLP, • Working knowledge of financial operations and budget development, • Relevant IT skills (Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities, • Drive to create and maintain order in a fluid technically complex environment, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • List required training that must be completed by incumbent in order to fulfill the responsibilities for this role. Examples can include aseptic techniques, gowning qualifications, manager training, GMP, etc., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the company, • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen, • Must have the ability to work in the cleanroom environment for extended period of time, • Must have the ability to work with specialized equipment, • May work with hazardous materials and chemicals, • Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description About the Job The primary function of this position is to oversee a full portfolio of approved and unapproved ANDA products. The incumbent might also be designated as U.S. Agent (back-up) for the U.S. Office for both ANDAs (GPI USA) and API (GLS India). The position includes a number of responsibilities that will require excellent communication to support both internal and external customers (globally) including the U.S. FDA. Job Responsibilities Note: These statements are not intended to be an exhaustive list of all responsibilities and duties. • Manage at least one (1) and possibly up to (2) direct reports to ensure their assigned responsibilities are completed accurately and on a timely basis to support the needs of the business for internal/external customers., • Support the U.S. Office for more than 170 approved ANDAs and all unapproved (under review ANDAs) as U.S. Agent back-up for all Glenmark subsidiaries including GPL, GSSA, GPI and GLS. The successful candidate will need to be able to review and sign various submissions to FDA. It will include ANDA cover letter, Form 356H for Original ANDAs, Amendments to ANDAs and/or Supplements to post-approval work. Form 2252 for Annual Reports., • Provide support/RA strategy needed to achieve timely approvals with the Agency., • Update the internal tracker that records all incoming and outgoing regulatory activities/communications for ANDAs/OTCs which may include submissions to FDA and Corresponding Acknowledgements, ANDA Amendments and Responses to CRL (minor/major), DRLs and IRs. The US Office is responsible to communicate these updates to the identified Sr. Management on a timely basis including R&D for unapproved products, RA India including post-approval team for post-approval activities. The email list is provided for such communications which includes Commercial Division Heads, R&D, QA, Legal, Business Development, Project Management, Demand Planning, Marketing and others identified on the list. It’s very important that these communications be shared with the FDA on a timely basis (typically the same day received from the FDA). Separate communications received from the FDA to support GLS will be sent to the GLS leadership team as identified., • Support OTC submissions, as needed, for ANDA conversion to OTC or OTC Monograph direct including any labeling reviews and updates., • Ensure all manufacturing, packaging, labeling, testing and BA/BE sites are registered with FDA in the CDER Portal, as applicable, • Ensure the payments are made on the scheduled due date to support all manufacturing sites., • Submit all Recalls and FARS to FDA for ANDAs and OTCs, as needed to support commercial. Submit subsequent updates to Recalls / FARS to FDA on a timely basis to meet the required deadline., • Submit controlled correspondences for R&D through CDER NextGen Portal., • Submission of PLAIRS accurately and timely as provided to the US Office., • Shipping samples to the FDA for CDRH evaluation of devices., • Submit pre-ANDA Meeting Packages to FDA, as needed, • Submit Responses to FDA Observations to support manufacturing sites, as needed Qualifications Education • Extensive experience in the pharmaceutical industry with at least 10+ years’ experience in a regulatory affairs., • Primary experience must be managing a significant number of generic drug products (ANDAs & OTCs)., • Capable and has the desire to manage at direct reports, as assigned., • Excellent communication skills including: verbal, reading and writing., • Use various labeling software tools such as TVT and/or Global Vision. Can be trained and have direct reports trained according to support labeling., • Proficient using MS word, MS excel, reviewing Drugs@FDA databases, USP database, FDA Orange Book, DP Specifie Bioequivalence Guideline and Dailymed Labeling, • The successful candidate must be proactive in reading and understanding assigned materials including FDA guidance, 21 CFR, USP general chapters, USP specific monographs, and internal SOPs as assigned., • The candidate must be a highly motivated, willing to be trained and be a self-learner in order to execute assigned tasks with attention to the details., • This will require direct prior experience doing the described activities., • It will in some instances require training, reading internal Standard Operating Procedures (SOPs), in-person training, and training by viewing FDA SBIA learning on-line video seminars or reading FDA guidance., • Read and understand current FDA guidance(s) and trends, USP general/specific DS/DP monographs, and be familiar with ICH guidelines and post-approval change guidance(s) accordingly., • Communicate with Supervisor and other Sr. Management on a timely basis when potential issues/concerns arise., • Use critical thinking skills and attention to detail is essential., • Ask questions and/or advice when in doubt., • The incumbent typically works in an office environment and uses a computer, telephone and other office equipment as needed to perform duties., • The noise level in the work environment is typical of that of an office, • Incumbent may encounter frequent interruptions throughout the workday. Salary Range - $160,000 – 185,000 The compensation range provided reflects the expected base compensation only and does not include potential bonuses, incentive plans, or benefits. An individual’s final compensation offer will be based on a variety of factors, including but not limited to education level, relevant experience, training, and geographic location. Benefits include: • Paid time off, • 401k plus company match, • Company paid health benefits, • Dental, • Vision, • Onsite access to company gym, • Paid Employee Referral Program, • EAP – Employee Assistance Program, • Accident Insurance, • Critical Illness Insurance, • Short-Term Disability, • Life and AD & D Insurance, • Whole Life Insurance, • Pet Insurance and so much more! About the Company Glenmark is a global leader in the development and commercialization of generic drugs of the highest quality and value. We help to improve people’s lives every day by helping to reduce their healthcare costs while delivering high-quality medicines. Established in 2003 as a North American subsidiary of Glenmark Pharmaceuticals, we launched our first generic product in January 2005 and quickly emerged as one of the leading generic organizations in the United States. Today we have a diverse business. As a global leader in generics, we are leveraging our industry expertise and success to fuel extensive research to expand development in specialty branded products innovative products that are intended to have a major impact on how people live. This job description is to serve as a guide. It is intended to be flexible and will continue to evolve over time with business needs and demands and may be updated periodically and at the Company’s discretion. Nothing in this position description changes or is intended to change the employment at-will relationship with the Company. Employment at-will means that an employee or the Company may terminate the employment relationship at any time, for any reason or no reason at all, with or without notice. Glenmark Pharmaceuticals is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Job DescriptionValidation Specialist Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device IT & Human Resources disciplines in New Jersey. The Validation Specialist performs validation activities primarily to include preparing and executing equipment and CSV protocols and preparing final reports for IQ, OQ and/or PQ of basic cell processing and QC lab equipment. The ideal candidate exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. • Prepare IQ/OQ and /or PQ protocols for various Cell Therapy manufacturing process equipment and QC test equipment such as Flow Cytometers, Cell Separators, Centrifuges, Cell processing equipment, clean utilities, Bioreactors, Automated Control Systems, etc., • Execute IQ/OQ and /or PQ protocols, • Prepare final reports for executed protocols, • Prepare final reports for vendor IQ, OQ and/or PQ protocols, • Review of executed IQ/OQ/PQ protocols and raw data, • Perform periodic review/requalification of validated equipment, systems and cleanrooms, • Manage assigned projects to completion in accordance with established timelines, following-up on review/approval cycles to ensure deadlines are met, • Assembling validation related documents; and filing/archiving approved documents, • Maintaining electronic records.REQUIREMENTS, • BS/BA in engineering or a related Science discipline, • 3-7 + years of validation experience, • Ability to use validation instruments such as Kaye Validator, Tachometer, Multimeter, etc., • Thorough knowledge of cGMP and regulatory requirements, including 21 CFR Part 11., • Excellent protocol and report writing skills, good oral communication skills, detail orientation, problem solving ability and teamwork are necessary., • Ability to comfortably interact and clearly communicate with individuals at all levels of the organization to provide project updates and follow-up communication for review cycle management., • Must be a dedicated self-starter with a high energy level and able to achieve results., • Must have strong problem-solving and critical thinking skills, with a track-record of successful issue resolution., • Good time management skills to manage and meet deadlines., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team environment., • Good computer skills and Microsoft Office knowledge., • Ability to multi-task team is essential., • Flexible and able to adapt to company growth and evolving responsibilities., • Highly organized, detail oriented, and ability to manage multiple priorities., • Ability to perform the job under direct or indirect supervision, • Must have the ability to work in a team-oriented environment and with clients, • Must have the ability to work with specialized equipmentMay occasionally work with pressurized systems. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.Ability to work in cleanroom environment for a moderate amount of time.Ability to lift, transfer, or ship validation equipment or related accessories.While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms. The employee is occasionally required to climb or balance; stoop, kneel, or crouch. Must where PPE when appropriate. This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionQC Microbiology Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. Leads life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools., • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approach., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process., • Manage CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS in a Quality / Process related field or equivalent experience., • 3-5 years of experience in quality control or quality assurance within the bio-pharma, biologics, or pharmaceutical industry or equivalent experience., • Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA, • Must have technical experience writing and assessing deviations, investigations, and Out of Specifications, • Must be able to analyze data/information and to assess and resolve complex problems, • Strong knowledge and understanding of U.S. and international cGMPs, ICH, and other regulations applicable to clinical and commercial manufacturing, • Knowledge of operational processes and controls in non-sterile and sterile operations, • Experience using e-Quality Management Systems preferred., • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Flexible and able to adapt to company growth and evolving responsibilities, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • Ability to work effectively as a team and independently., • Training; GMP Training, Quality Systems Training (Deviation/CAPA), Safety Training, Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionWho we are… Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer. What you’ll be doing The Clinical Compliance and Training Manager role is vital in maintaining and enhancing the quality and efficiency of clinical trials. This position is responsible for ensuring that clinical trial activities are conducted in compliance with regulatory guidelines, company policies and SOPs, and Good Clinical Practice (GCP) standards. The individual in this role will implement and oversee quality control processes, drive continuous improvement initiatives, and play a crucial role in ensuring the overall success of clinical trials. This individual will also coordinate training for the clinical team to ensure all team members are trained on SOPs and regulation. You will be responsible for... • Quality Control and Compliance, • Monitor clinical trial activities to ensure they meet all regulatory requirements (FDA, EMA, ICH-GCP) and internal standard operating procedures (SOPs)., • Conduct regular review and quality checks on trial processes, documentation, and deliverables to ensure accuracy, completeness, and compliance with protocols., • Oversee clinical system use and management, including implementation, maintenance, and end user training., • Ensure all trial-related documentation is inspection-ready and compliant with regulatory standards. May support set, • Support the oversight of set-up of any TMF with vendors to ensure adequate implementation, including review process, ensuring TMF completeness and supporting the transfer of the TMF upon study closure., • Act as a liaison between clinical operations and quality assurance teams, ensuring alignment on quality standards and goals., • Analyze key quality metrics (e.g., protocol deviations, audit findings, KPIs from clinical systems) to identify trends and areas for improvement., • Process improvement and Optimization, • Identify areas for process improvement within clinical operations, focusing on enhancing efficiency and reducing errors., • Support corrective and preventive actions (CAPAs) to address any quality issues or deviations identified during audits or reviews., • Work closely with clinical operations to optimize trial processes and ensure alignment with company goals., • Use data-driven insights to recommend and implement continuous improvement strategies including as applicable, implementing new technologies, tools, and best practices., • Stay updated on industry trends, evolving regulations, and innovations in quality management, ensuring the organization remains at the forefront of clinical trial excellence., • Establish a quality improvement framework to foster innovation and improve trial efficiency and compliance., • Training and Guidance, • Provide training, guidance, and support to clinical teams on quality control best practices and regulatory compliance., • Develop and deliver training programs focused on GCP compliance, risk management, and quality improvement initiatives., • Foster a culture of continuous learning and quality excellence within the clinical operations team., • Risk Management and Issue Resolution, • Identify and assess risks related to clinical trial quality, including potential regulatory compliance issues., • Ensure risk mitigation strategies are well managed for each study to minimize the impact of issues that could delay or jeopardize clinical trial success., • Proactively identify any potential quality-related issues, working closely with study teams to resolve problems efficiently.What Knowledge & Experience you'll bring to us..., • Minimum Educational Requirement:, • Bachelor’s degree in life sciences, healthcare, or a related field preferred; equivalent work experience will be considered., • Minimum of 5 years of applicable industry experience in drug development, preference for experience in a small, start-up environment. Early and late-stage (Phase 1-3) as well as US and China experience also preferred., • Robust understanding of use and management of validated, Part 11 compliant systems, • Core Competencies, • Current knowledge and understanding of FDA and ICH Guidelines, including Good Clinical Practices (GCP) E6(R3) requirements., • Proven experience in clinical operations in the pharmaceutical or biotechnology industry and ability to use that experience to provide training, • Strong problem-solving, and analytical skills, with the ability to identify risks and propose effective solutions., • Excellent communication and collaboration skills to work with cross-functional teams., • Strong attention to detail with a focus on accuracy and thoroughness in quality control processes, • Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment., • Proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet, • Travel may be required (5%), • Excellent communication and interpersonal skills., • Must be able to write clearly and summarize information effectively., • Must be able to present complex information to various audiences.Behavioral skills to be successful..., • Problem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges., • Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives., • Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource., • Emotional intelligence, curiosity, and a knack to figure out a way to build something better, • Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders., • Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity., • Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.What we have for you!, • Competitive Base Salary, Bonus, and Equity Plans, • Unlimited Vacation and 10 Sick Days Annually, • Excellent Medical, Dental, and Vision Coverage, • 401K with Company Matching Disclaimer Nuvation Bio, Inc. is an equal opportunity employer, and, in accordance with applicable federal, state, and/or local law, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law. This job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Note to all external Recruiters & Staffing Agencies All of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.

Job DescriptionQuality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports; review of QC data; perform material releases and final product releases; review of Deviations as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. This role manages internal and external audits which may include interaction with Health Authorities and clients • Interfaces directly with client and cross functional teams, • Provides resolutions pertaining to quality for project related issues, • Independently prioritize, schedule, and manage multiple projects and resources (team), • Ensures the safe release of cellular products in accordance with company and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Able to provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Author and review relevant SOPs, validation and other documents., • Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Responsible for the completion of all client requirements related to cellular product and/or material releases., • Master Batch Record Control, distribution and label verification, • Perform line clearance activities as required., • Assignment and maintenance of product Lot numbers as applicable., • Perform internal documentation audits as assigned., • Materials management nonconformance disposition and release activity as applicable., • Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Track and trend relevant quality metrics including environmental monitoring data., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Electronic Document Control activities as assigned., • Provide training to personnel as assigned by supervisor., • Travel may be required.REQUIREMENTS, • BS in biological sciences or other relevant field of study, • 5 years + experience in QA in a life sciences company company with a strong focus in the manufacturing and/or testing of biologics., • Working knowledge and technical understanding of aseptic manufacture of biologics, • Understanding of quality system applications, • Experience in both clinical and commercial manufacturing is preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. Etc., • Experience in organizing teams for effective and timely completion of projects., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience participating in or hosting health authority inspections and/or client audits., • Computer skills (Microsoft Office, Outlook), • Detail-oriented and organized, • Analytical and problem-solving skills, • Good written and oral communication skills, • Ability to multi-task and be adaptable, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work independently and with a team, • Strong Project Management and organization skills, • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the companyMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Job Title: Computer System Validation (CSV) Engineer Industry: Pharmaceutical / Biotechnology About the Role We are seeking a skilled Computer System Validation (CSV) Engineer to support validation and compliance activities within our pharmaceutical operations. The role focuses on ensuring computerized systems meet regulatory requirements, function reliably, and comply with GxP standards. Key Responsibilities * Develop, review, and execute Validation Plans, Test Scripts (IQ/OQ/PQ), and Traceability Matrices. * Perform risk assessments, impact analyses, and ensure system compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines. * Collaborate with QA, IT, Manufacturing, and Engineering teams to validate laboratory systems (LIMS, CDS, etc.), manufacturing execution systems (MES), ERP, and other GxP applications. * Document deviations, manage change control, and support system audits and regulatory inspections. * Ensure adherence to company policies, SOPs, and cGMP requirements. * Provide training and guidance on CSV processes and best practices. Qualifications & Skills * Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field. * Proven experience (2–7 years) in CSV, IT compliance, or Quality Assurance in the pharma/biotech sector. * Strong knowledge of GxP, cGMP, 21 CFR Part 11, GAMP 5, and data integrity principles. * Hands-on experience with validation of laboratory, manufacturing, and business systems. * Excellent documentation, problem-solving, and communication skills. * Familiarity with project management and cross-functional team collaboration. Thanks Suchi Company DescriptionVastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.Vastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The Senior Process Engineer or Process Engineer II will support and lead manufacturing process development and optimization for our medical device products. This position plays a key role in ensuring that all manufacturing processes meet quality, compliance, and performance standards. The engineer will work closely with cross-functional teams including Quality, R&D, Regulatory, and Production developing, optimizing, and scaling manufacturing processes to improve yield, throughput, quality, and efficiency. The Process Engineer will have a strong operational, quality, and technical background. This is often a hands-on role working closely with the production team to train operators to new processes, troubleshoot equipment challenges, and write and execute qualifications and validations. This is a full-time, on-site position, located in Brooklyn, New York. It is a multi-faceted role in a highly collaborative environment that will require creativity and focused execution in pursuit of maximizing production outputs and creating robust manufacturing processes. Responsibilities: · Design, develop, and optimize manufacturing processes for new and existing medical devices. · Lead process development for new product introductions (NPI), from concept through validation and launch. · Develop and refine manufacturing processes to reduce variation, increase yield, improve cycle times, and reduce cost. · Evaluate and implement automation technologies to improve process consistency and throughput. · Interface with external vendors and suppliers to specify new equipment, product or process requirements, or troubleshoot product issues. · Analyze production data to identify trends, root causes, and opportunities for efficiency. · Maintain and update validation documentation as part of lifecycle management. · Ensure processes comply with applicable regulatory requirements and internal quality standards. · Lead root cause investigations (CAPA, NCRs, SCARs) and implement corrective and preventive actions. · Develop process documentation including standard operating procedures (SOPs), work instructions, pFMEAs, and equipment qualifications. · Partner with R&D during design transfer to ensure design for manufacturability (DFM) and seamless product integration. · Collaborate with Quality and Regulatory teams to support audits, inspections, and compliance initiatives. · Provide technical leadership and mentorship to junior engineers and technicians (for Senior level). · Monitor and analyze key process indicators (KPIs), quality metrics, and manufacturing data · Specify, procure, and validate manufacturing equipment and tooling. · Author and execute process validation protocols (IQ/OQ/PQ) in accordance with FDA and ISO 13485 standards. · Train manufacturing personnel on new or revised processes and equipment. · Provide ongoing floor support for manufacturing operations, helping to resolve technical issues in real time. · Other duties may be assigned as deemed necessary by management Requirements · Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related field. · Process Engineer II: 5+ years of experience in a regulated manufacturing environment with 3+ years process development, design, and process implementation required. · Senior Process Engineer: 10+ years of experience in a regulated manufacturing environment with at least 5 years hands-on experience in process development, design, and process implementation required, preferably in medical device, pharmaceutical, or biotech manufacturing. · Understanding of FDA 21 CFR Part 820, ISO 13485, and GMP requirements. · Proven experience with process validation (IQ/OQ/PQ), root cause analysis, and CAPA. · Proven experience in process design, optimization, and troubleshooting. · Experience implementing process and quality improvements into manufacturing or CMO · Strong analytical and problem-solving skills. · Ability to multitask and prioritize work, while remaining detail-oriented. · Demonstrated experience training technical personnel. · Familiarity with data analysis tools and manufacturing software. · Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. · Experience with Lean Manufacturing, Six Sigma, or similar methodologies. · Hands-on experience with manufacturing processes such as formulation, fill and finish, packaging, and CIP. · Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner. · Demonstrated experience managing third-party vendors and service providers. · Demonstrated ability to work independently as well as be a strong team contributor. · Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks. · Excellent verbal and written communication skills required. · Ability to become gowning qualified to work in a cleanroom environment. · Ability to speak, listen, and understand verbal and written communication in English. · Ability to lift 30 pounds of force occasionally and to lift, carry, push, pull, or otherwise move objects. · Strong computer skills, with proficiency in the use of Microsoft Excel, Microsoft Word, Microsoft PowerPoint. · Legal authorization to work in the United States. Preferred Qualifications: · Master’s degree in Engineering or related field. · Experience in medical device or pharmaceutical · 3+ years of relevant cGMP manufacturing experience. · Experience in cleanroom operations, including aseptic processing. · Experience with CMOs. · Significant experience with CAD software · Experience in supporting regulatory inspections and audit readiness. · Six Sigma certification (Green or Black Belt) or Lean Manufacturing experience. · Mechanical/Electrical knowledge with the ability to troubleshoot equipment · Strong leadership skills with the ability to influence and motivate a cross-functional team · Organizational and time management skills with the ability to prioritize a variety of tasks/projects. · Demonstrated understanding of aseptic processing and microbial control concepts. Benefits Competitive annual base salary range of $90,000 - $150,000, depending upon job level and qualifications. · Paid Vacation, Sick, & Holidays · Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage · Company Paid Life and Short-Term Disability Coverage · Work/Life Employee Assistance Program · 401(k) & Roth Retirement Savings Plan with company match up to 5% · Monthly MetroCard Reimbursement Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The R&D Engineer I/II is responsible for supporting product design and process development activities while ensuring compliance with all quality and regulatory requirements. The position has a scientific focus that includes implementation of formulation development through process development, prototype fabrication, and characterization, along with additional process evaluation and data generation through designed experiments. Process development in an R&D environment will be followed by qualification and technology transfer into manufacturing. Collaboration is a key aspect of this role, as the engineer will work within a multidisciplinary team of researchers and engineers. The position offers diverse opportunities in a collaborative cross-functional environment, requiring adaptability, flexibility, and a willingness to learn and innovate in the exploration of new technologies, new approaches, and techniques in pursuit of product/process robustness and innovation. The R&D Engineer I/II is expected to possess expertise in areas including, but not restricted to, polymer, chemical, material science, and process development and engineering. Additionally, they will assist in generating documentation essential for regulatory submissions, ongoing publication initiatives, and direct communication with the Head of Research regarding various tasks. This is a full-time, on-site position, located in Brooklyn, New York. This role is an independent contributor role (i.e. no direct reports). Level is dependent on experience. Responsibilities: • Oversee the planning, implementation, and analysis of experiments relevant to project objectives. Ensure the application of established scientific and engineering principles to solve complex problems and challenges innovatively and efficiently, adhering to rigorous scientific methodologies and protocols., • Create and execute product/process enhancement, and new product/process development plans., • Lead material/design/process changes and their implementation with well-documented research/analyses. Process and analyze results,, • Author protocols and reports including engineering studies and design verification/validation activities., • Aid in the development and execution of testing methods to aid in exploratory research, product/process development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes., • Prepare samples as required for manufacturing, testing, or other evaluations and data analysis., • Participate in voice-of-customer (VOC) labs and other user needs assessments., • Interface with external vendors, customers, and suppliers. Specify equipment and process requirements for developing and implementing new products, product improvement and new equipment/processes., • Support process and product transfers to manufacturing or CDMOs., • Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines., • Understand and prioritize process improvements, design experiments to make those improvements, and execute these plans in the laboratory., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation about research towards FDA/regulated authority submissions., • Provide support to the marketing and sales team, with the development of presentations, sales tools, and application data., • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. Required Qualifications • Education: BS in Chemical Engineering, Polymer Engineering, Material Science & Engineering, or related engineering discipline., • Minimum 4+ years previous experience in an industrial environment with a BS degree. (2 years minimum experience if advanced degrees)., • Proficiency as an adept experimentalist with hands-on experience in the process development of polymeric materials and their characterization in an R&D or manufacturing environment., • Mathematically inclined with strong analytical and problem-solving skills with the ability to be observant and to think creatively. Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. Demonstrated ability to work independently as well as be a strong team contributor. Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks., • Requires understanding of product/process design and engineering. Experience should include process development/validation and/or transfer/verification, protocols, and troubleshooting skills., • Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency on time., • Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills., • Working knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP) requirements., • Proficiency in the use of Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint is required., • Requires excellent written and verbal communication and presentation skills., • Legal authorization to work in the United States is required., • Physical Requirements include:, • Aseptic Gowning Qualification: Able to be successfully qualified for aseptic gowning, including successful respirator training., • Wear Appropriate Personal Protective Equipment (PPE):, • Be able to stand and walk for prolonged periods, with the ability to climb, balance, stoop, bend, reach, and handle equipment., • Ability to speak, listen, and understand verbal and written communication., • Possesses hand-eye coordination and manual dexterity for delicate manipulations., • Ability to lift up to 50 pounds occasionally and to carry, push, pull, or otherwise move objects., • Visual acuity is required for performing close and distant activities. Preferred Qualifications • An advanced technical degree (MS or PhD)., • ·Lab experience in an industry setting within cGMP-regulated environments., • Prior experience developing processes and scaling these up into manufacturing or CDMO, • Mechanical/electrical knowledge with the ability to troubleshoot processing equipment, • Six Sigma green belt or black belt certification preferred., • Experience implementing process and quality improvements in a manufacturing environment, • Work experience with the medical device or pharmaceutical industries, • Working knowledge of ISO 9001, ISO 13485:2003 and ISO 14971:200., • Working knowledge of FDA requirements as per 21 CFR 820. Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits • Competitive annual base salary range of $70,000 - $120,000, depending upon job level and qualifications, • Paid Vacation, Sick, & Holidays, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Work/Life Employee Assistance Program, • Company Paid Life and Short-Term Disability Coverage, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

Job Description The Quality Assurance Technician is responsible for routine inspection and testing of raw materials and components as well as of final product for Cresilon’s products in the Animal and Human Health industries. This position requires a strong attention to detail as the individual will be responsible for identifying deviations in product quality or safety and ensuring compliance with local, state, and federal regulations, including current Good Manufacturing Practices (cGMP). Position is for 2nd shift. Responsibilities: • Sample and perform visual inspection of final products and raw materials. Perform other testing under the direction of QA Operations Manager., • Perform line clearance activities and in-process inspections., • Monitor routine manufacturing operations for conformance to applicable procedures (see Gowning Qualification requirements below), • Transfer materials between facilities (see lifting requirements below), • Facility 1 of 2: 122 18th Street, Brooklyn, NY 11215, • Facility 2 of 2: 87 35th Street, Suite 603/604/6R, Brooklyn, NY 11232, • Operate testing equipment such as force testers, torque testers, and balances., • Report all deviations in product, components, raw materials, and equipment per their relevant procedures, • Perform document control activities, including but not limited to printing logbooks and batch records., • Transcribe data into digital systems for tracking Quality Metrics., • Batch record review & support routine batch disposition Requirements Education: High School Diploma or Equivalent (2- or 4-year degree in Engineering, Science, or Technology/Biotechnology preferred) • Required experience in GMP and FDA regulated environments (ISO 13485:2016 preferred), • Ability to be Gowning Qualified per Cresilon’s SOP., • 1 year experience in regulated industry highly desirable · Paid Vacation, Sick, & Holidays · Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage · Company Paid Life and Short-Term Disability Coverage · Work/Life Employee Assistance Program · 401(k) & Roth Retirement Savings Plan with company match up to 5% · Monthly MetroCard Reimbursement The salary for this role is $25/Hour Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Job DescriptionAssociate General Counsel Fully Remote | Fast-Growing Biotech/Pharma Company Compensation: $200,000 – $300,000 Base + More Join a mission-driven biotech company transforming the future of rare autoimmune disease treatment. We’re developing innovative therapies for patients who need them most—and we’re looking for a strategic legal partner to help guide our growth. About the Role We’re adding an Associate General Counsel to our dynamic legal team. Reporting directly to the General Counsel, you’ll be a key business partner across the company, providing practical legal advice, driving compliance initiatives, and ensuring that we move fast while staying grounded in ethics and integrity. This is an opportunity to do meaningful work at the intersection of science, law, and business—where your impact will be felt across patients, employees, and the broader healthcare community. What You’ll Do * Keep Us Compliant: Navigate the complex biotech regulatory landscape and ensure we’re ahead of the curve on evolving laws. * Strengthen Our Culture of Integrity: Develop and deliver engaging training on compliance topics—from our Code of Conduct to anti-bribery and anti-kickback rules—while continuously refining company policies. * Be a Deal-Maker: Draft, review, and negotiate critical agreements (clinical trial, licensing, manufacturing, research collaborations, vendor, and more). * Enable Commercial Success: Partner with the commercial team to review promotional materials, advertising, and other go-to-market initiatives. * Protect and Empower: Spot legal risks early, propose smart solutions, and balance business agility with compliance. * Collaborate Across Teams: Work side-by-side with colleagues in R&D, Regulatory Affairs, Quality, HR, Finance, and Commercial to deliver clear, actionable guidance. * Be a Trusted Advisor: Foster trust at every level of the organization, championing ethical business practices and sound judgment. What You’ll Bring * JD (or equivalent) with active bar membership in good standing. * 10+ years of legal experience in biotech, pharma, or life sciences (in-house or at a top firm advising clients in these sectors). * Deep knowledge of the regulations shaping the biotechnology industry. * Proven success drafting and negotiating complex agreements. * Familiarity with global privacy frameworks (e.g., GDPR). * A reputation for providing clear, business-oriented legal counsel in fast-moving environments. * Exceptional communication and relationship-building skills—you can talk science with scientists, strategy with executives, and compliance with employees. * Impeccable ethics, attention to detail, and the ability to juggle multiple priorities without losing focus. Why Join Us? This isn’t just another legal role. It’s a chance to help shape a high-growth biotech company as it brings life-changing medicines to market. You’ll work with passionate, driven colleagues in a collaborative environment where your voice matters and your work has a direct impact on patients’ lives. If this sounds like something you are interested in, apply today!

About the Company: Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion Healthcare, which suggested a new growth model in the Korean biopharmaceutical industry through biosimilars, is now advancing to new challenges to become a global pharmaceutical provider. Just as it has overcome many obstacles in the past, Celltrion Healthcare will successfully pave the path for global direct selling, which has never been achieved yet by Korean biopharmaceutical companies. As it continues to surpass its current success, Celltrion Healthcare will take a leap forward to become a leading global biopharmaceutical company. Celltrion Healthcare provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world. POSITION SUMMARY Responsible for management of quality assurance department of Celltrion USA. Operate and maintain a quality system for the distribution of biopharmaceutical products, ensuring full compliance with Good Distribution Practice (GDP), including 21 CFR Part 210/211 or 21 CFR Part 820 KEY ROLES AND RESPONSIBILITIES • Make decisions related to Quality issues in support of company’s business and operational objectives, • Report directly to the Quality Assurance Director routinely to ensure that Quality Assurance Director is adequately and timely informed of the status of the quality system, • Review and approve all quality activities, including review and approval of all quality system SOPs, • Review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the applicable requirements of the Quality System Regulation (QSR) as set forth under 21 C.F.R. Part 820 and CELLTRION USA's established quality policies, procedures, and objectives, • Ensure quality system procedures and instructions are established and maintained, • Provide quality compliance guidance and training to all staff on QMS SOPs and its applicable provisions, • Lead initiatives for the continuous improvement of the quality system and ensure that measurable results are achieved, • Stay current on industry best practices, trends, and relevant regulatory intelligence, • Provide regular communication across all divisions, including the marketing and sales organizations, regarding Quality System management for Good Distribution Practice(GDP), • Manage routine quality meetings with staff and Celltrion’s Corporate QA team, • Collaborate with Celltrion’s Corporate QA team on the management of quality systems at Celltrion USA, • Conduct on-site or remote audits of Third-Party Logistics(3PL) sites and other services providers. WORK EXPERIENCE • 10+ years’ experience in quality assurance (QA) at a pharmaceutical company, • Prefer to have 3-5 years in a manager role in a biotechnology/LifeScience industry or specifically in the Good Distribution Practice (GDP) of biopharmaceutical products., • Strong knowledge of Quality Management Systems(QMS) for the Good Distribution Practice (GDP) of biopharmaceutical products SKILLS AND SPECIFICATIONS • Excellent oral and written communication skills, • Recognized as a great listener, learner, and strategic contributor, • Proven management skills including communicating with executive management, • Experienced in the management of a regulated medical products company EDUCATION Bachelor's degree or above. CORE COMPETENCIES Ethics and Values Regulatory Knowledge Conflict Management Problem Solving Personal Learning Action Oriented Timely Decision Making Organizational Agility Drive for Results Celltrion USA is an equal opportunity employer. It is our policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. #LI-DD

Job Description Job Description Date Written: Jul 29, 2025 Job Title: Chief Scientific and Impact Officer Location: Remote Department: Research & Development Reports to: CEO Wage Category: Exempt About CTF The Children’s Tumor Foundation (CTF) is not a traditional research foundation. We operate as a patient-centered drug discovery engine for NF, a group of genetic conditions that cause tumors to grow on nerves affecting 1 in 2,000 individuals. We operate by accelerating the full continuum of scientific discovery, from basic research through translation to clinical trials and approved treatments — while empowering patients and building the financial infrastructure to support that journey. We catalyze progress by uniting academia, industry, regulators, and patient advocates around shared goals. General Summary The Chief Scientific & Impact Officer (CSIO) reports to the CEO and is a strategic partner of the Executive Leadership Team. The CSIO will lead CTF’s research portfolio and drive partnerships that convert scientific breakthroughs into real-world therapies. TThe CSIO will manage a multidisciplinary team covering basic science, translational development, clinical strategy, and therapeutic scouting. The ideal candidate will not only understand science but will also bring a business development mindset to scientific innovation. The CSIO will identify opportunities, de-risking assets, and build collaborations that scale our impact. This role sits at the intersection of R&D strategy, translational execution, stakeholder alignment, and market-savvy decision-making. The CSIO will help steer CTF’s research pipeline and its financial pipeline including philanthropic funding to venture partnerships and commercial exits. Principal Duties and Responsibilities Strategic & Scientific Leadership * Lead the design and execution of an integrated research strategy spanning basic science, translation, clinical trials, and therapeutic repurposing or repositioning. * Oversee and coach a high-performing team of direct reports leading core scientific domains. * Serve as a thought partner to the CEO and Board on scientific and translational investment decisions. Business Development & Strategic Partnerships * Proactively identify, evaluate, and pursue high-impact partnership opportunities with biotech, pharma, CROs, investors, and academic institutions. * Support due diligence and asset triage, including shelved, preclinical, and early-stage therapeutic candidates. * Develop and structure public-private collaborations and co-funding mechanisms to drive therapeutic progress and leverage CTF capital. * In conjunction with the CEO build sustainable financial models for future CTF initiatives, including venture philanthropy, risk-sharing agreements, and translational consortia. * Build and oversee the financial budget for research, preclinical and clinical development, and key scientific activities. Stakeholder Engagement & Ecosystem Building * Act as a trusted convener across the research ecosystem including but not limited to regulators and researchers to investors and advocates. * Represent CTF in platform trials, biomarker programs, and international R&D alliances. * Maintain CTF’s neutral, non-conflicted role as an honest broker and trusted partner. Communication of Impact * Translate complex scientific programs into clear, outcomes-driven narratives for funders, partners, policymakers, and patients. * Demonstrate and quantify the return on CTF’s research investments — in terms of both patient outcomes and leveraged funding. * Represent CTF and its programs to medical and regulatory communities and pharmaceutical and biotechnology industry collaborators and partners, i.e. conferences, etc. Minimum Qualifications * Advanced degree (MD, PhD, or equivalent) in a biomedical field. * Significant leadership experience in biomedical R&D, ideally with exposure to both academic and industry environments. * Demonstrated experience in business development, licensing, strategic partnerships, or venture/scientific investment in rare diseases, oncology, or translational science. * Proven ability to work across scientific, financial, and operational domains to deliver outcomes. * Strong people leader with a track record of managing diverse, high-impact teams. * Deep understanding of the therapeutic development lifecycle, including biomarker discovery, regulatory interaction, and commercialization pathways. * Comfort navigating ambiguity and balancing scientific rigor with entrepreneurial agility. * Highly collaborative and diplomatic, with exceptional communication skills and executive presence. * Passion for patient-centered innovation and mission-driven work. * Strategic and innovative thinker with proven ability to communicate a vision and drive results. * Ability to communicate complex scientific concepts to diverse audiences, including policymakers, patients, and donors. * Demonstrated ability to secure and manage research funding. * Leadership experience, including managing teams and cross-sector collaborations. * Deep commitment to rare disease research and patient advocacy. * Experience working with the FDA, NIH, and regulatory agencies on rare disease policies and funding is a plus. Responsible for setting objectives and priorities for the Medical Advisory Boards in collaboration with the CTF Europe CSO and CTF CEO. * Lead efforts to secure research funding, including NIH, FDA, and philanthropic grants. .WORKING CONDITIONS, EQUIPMENT USED AND SPECIAL INFORMATION The CSO must have unimpeachable integrity and trustworthiness, while possessing a high degree of tact, discretion and professionalism. Maintain effectiveness under pressure. Flexible for moderate overnight business travel which may include weekends. DISCLAIMER The above statements are intended to describe the general nature and level of work being performed by the person assigned to this position. They are not intended to be considered an exhaustive list of all responsibilities, duties and skills required. Equal Employment Opportunity CTF and ADP provide equal employment opportunities to all employees and applicants in all Foundation facilities without regard to race, color, religious creed, sex, national origin, ancestry, citizenship status, pregnancy, childbirth, (or related medical conditions, including, but not limited to lactation), physical disability, mental and intellectual disability, age, military status or status as a Vietnam-era or special disabled veteran, marital status, registered domestic partner or civil union status, gender (including sex stereotyping and gender identity or expression), medical condition (including, but not limited to, cancer-related or HIV/AIDS-related), genetic information, or sexual orientation under applicable federal, state and local laws. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.