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Job DescriptionJob Title: QA InvestigatorJob Description We are seeking a dedicated QA Investigator to join our team. The role involves writing and completing investigations and deviations, ensuring compliance from both compliance and operations perspectives. The ideal candidate will conduct root cause analysis and manage the entire lifecycle of investigations independently, communicating effectively with vendors and manufacturing teams. Responsibilities • Determine the causes and preventative actions of Deviations, Non-Conformances, Out of Specification (OOS), Out of Trend (OOT), field complaints, and environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools and 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 to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track Corrective and Preventive Action (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 approaches., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy, and deviation processes., • Champion CAPA plans and implementation., • Provide communication plans for ongoing deviations and CAPAs., • Create and communicate CAPA plans effectively to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • 2-3 years of experience writing and reviewing deviations and investigations., • Experience within a pharma company supporting manufacturing., • Previous experience within a quality assurance team., • Bachelors degree within a related scientific 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 operations., • Experience using e-Quality Management Systems., • Experience with CAPA and GMP., • Knowledge of biopharma/biotech and biologics., • Technical writing skills. The QA Investigator will work closely with quality assurance and a team of QA/QC professionals on a daily basis, collaborating cross-functionally with the manufacturing team. The role is based at two sites located a block apart, and the team currently includes five other investigators. The position operates on a first-shift schedule from Monday through Friday, with start times at either 8 am or 9 am. The company offers a supportive work culture with opportunities for growth and expansion, focused on saving patients' lives. Job Type & Location This is a Contract to Hire position based out of Allendale, New Jersey. Pay and Benefits The pay range for this position is $40.00 - $46.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ. Application Deadline This position is anticipated to close on Oct 16, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

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 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.

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.

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.

Nanion Technologies Inc. is a rapidly growing instrumentation company, offering automated ion channel screening platforms to industry and academic research institutions globally. To support the increasing demand for our technologies and strengthen customer engagement, we are expanding our commercial team in North America. We are seeking a Regional Scientific Sales Manager to drive the growth of our Automated Patch Clamp (APC) portfolio – including Port-a-Patch, Patchliner and SyncroPatch systems to join our team – across the U.S. and Canadian markets. The role reports to the Director of Sales, North America and involves close interaction with our inside sales, marketing, technical and product development teams. Responsibilities: · Own and manage the entire sales process: prospecting, customer meetings, presentations, quoting, follow-ups, and account management · Will be responsible for selling our portfolio of Automated Patch Clamp (APC)instruments. · Actively identify and engage new customers in Academia, Biotech, Pharmaceuticals and CRO’s · Work directly with our inside sales and marketing team to generate leads · Build and maintain strong relationships with existing customers to ensure customer satisfaction and long-term retention. · Approximately 50-75% travel required across North America (overnight travel expected) · Occasional international travel for training, meetings and/or events at HQ in Munich, Germany · Attend and represent Nanion at conference, symposiums and workshops · Achieve and/or exceed sales targets across the APC products, including the Port-a-Patch, Patchliner and SyncroPatch. · Participate in conferences, symposiums, etc. · Present and promote our APC systems, both remotely and on-site in collaboration with our Field Application Scientist (FAS). · Provide regular & accurate sales pipeline forecasts as well as account management in CRM system (Salesforce) Position Skills and/or Requirements: · Minimum of Bachelor’s or Master's degree in Life Sciences, Pharmacology, Biophysics or related field. · Minimum 6-8 years' experience selling into the life science market (Pharma, Biotech, CRO and/or Academia) · Strong understanding of HTS, ion channel research, and automated electrophysiology is strongly recommended · Strategic thinker with a self-starter mindset, able to manage complex accounts and deliver results independently · Ideally, this role would be located near New Jersey or San Francisco offices · Selling into Life Sciences, including Biotech, Pharma, CRO’s and Academia is preferred · Capital Equipment sales experience is preferred · Must have a strong background in life sciences as well as a well-developed technical aptitude in software. · Create and develop sales strategies. Work is accomplished in a proactive manner without considerable direction. Able to create and develop resolution independently to complex problems while meeting sales objectives · Excellent knowledge of the academic, pharmaceutical, biotechnology industry related to HTS and automated patch clamp technology · Self-directed, strategic solutions-based approach to territory and account management · Willingness and ability to take on additional challenging tasks/project responsibilities assigned by manager, senior management, or others · Working in a team environment · Previous experience of Salesforce (or similar CRM platforms) as well as Microsoft office · Maintain and grow monthly, quarterly sales goals · Self-starter in lead generation and account management · Excellent verbal and written technical communication skills with an emphasis on ability to present effectively to a diverse audience Compensation & Benefits · Competitive compensation package · Health, 401k and additional benefits · Travel cost covered · Opportunities for training and development, including periodic visits to HQ in Munich, Germany To Apply: Please send Cover Letter and Resume to

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

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

About Us Evergreen Theragnostics is a Lantheus owned company, headquartered in Bedford, Massachusetts with offices in Springfield, New Jersey. Evergreen Theragnostics is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Evergreen our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands. We believe in helping people be their best and seek to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team. Purpose The Associate Director, Technology Development and Transfer, acts as a technology development and transfer lead in the Tech Ops organization at Evergreen Theragnostics. This position will lead and manage the Manufacturing Science and Technology (MSAT) team at Evergreen. This role will be accountable for the technical work between internal and external stakeholders to ensure design, development, and transfer of robust manufacturing processes for new products and key lifecycle injectable pharmaceutical finished products. This role will be the principal expert and process owner for the end-to-end manufacturing process for injectable pharmaceutical finished products at Evergreen Theragnostics. Ensures processes are designed and validated per applicable cGMPs, Evergreen Theragnostics’ procedures, and that processes are defined consistent with regulatory filings. This role must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices. The role will also be responsible for review and authoring of key CMC submissions, along with setting relevant standards and creating /maintaining associated tech development transfer business processes. Key Responsibilities/Essential Functions • Leads technology development and transfer projects for key lifecycle injectable radiopharmaceutical products, including the establishment of the process/parameters for each unit operation of the process, and up until the completion of process performance qualification and subsequent CMC filing activities., • Leads a team of engineers/scientists to execute the development, characterization, optimization and troubleshooting product and manufacturing processes of parenteral dosage forms., • Leads a team of engineers/scientists to Perform Design of Experiments and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies (PCS)., • Designs, prepares, and reviews technology transfer protocols, methods/processes, experimental or authoring plans or templates as appropriate. Responsible to create, maintain and harmonize key tech transfer business processes with internal and external stakeholders., • Partners with the Internal and CDMO management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage., • Partners with Business Development (BD) team in identifying and evaluating new technological platforms and pipeline products for Evergreen Theragnostics’ business growth., • Partners with site operations to provide a parenteral manufacturing process that is sustainable for future product supply. Partners with existing sites in the network to incorporate lessons learned from ‘sending’ sites for an optimized manufacturing process., • Leads, motivates, mentors, and develops team members to exceed and meet company goals., • Develops and maintains effective working relationships with other division groups and external partners in support of technology transfer, validation, and process support activities., • Leads a team of engineers/scientists to own QEs (i.e. Change controls, Investigations, CAPAs, Protocol & report writing), • Responsible to review and co-author key CMC sections with external partners and cross functional stakeholders., • Requires approximately ~20% travel., • Actively promotes safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment., • Reports and takes initiative to correct safety and environmental hazards., • Actively demonstrates Evergreen Theragnostics’ values. Typical Minimum Skills and Experience and Education • Requirements include a B.S. or M.S. in relevant scientific/technical disciplines, advanced degrees (e.g., PhD) or technological certificates preferred but not required., • 5+ years of experience in the radiopharmaceutical industry, including 3+ years focused on technology development and tech transfer activities., • If no prior radiopharmaceutical experience, 10+ years of work experience within pharmaceutical or medical device industry, 5+ years of technology development and transfer experience, within a matrixed pharmaceutical, medical device, or biotechnology organization., • Previous experience working with aseptically filled/finished drug products, medical device, radiopharmaceuticals and CDMO management strongly preferred. Other Requirements • Subject matter expert (SME) in parenteral operations: aseptic processing, sterilization, sterile filtration, isolator technology operations. Strong knowledge of global regulatory requirements related to the design and control of these processes., • Knowledge of SOPs, cGMPs and GLPs and the ability to work and manage within a regulatory environment., • Demonstrated experience with the execution of technology transfer and scale up programs for commercial drug product manufacturing processes., • Ability to work within and lead different technical teams., • Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing., • Excellent organizational skills and the ability to successfully manage a multitude of technical projects., • Ability to work in a prompt, complex and changing environment., • Excellent analytical, technical and experiences., • Proactive mindset with strong leadership, facilitation, teamwork, and influence management/negotiation skills., • Understanding of FDA and/or EMA quality and regulatory processes. Prior experience with regulatory filings is highly desired., • Experience working with external partners is highly desirable., • Ability to work independently in decision-making and resolution of program obstacles and conflicts., • Keen insight, independent judgment and tactful discretion are required., • Ability to function autonomously, with an appreciation of detail while being cognizant of “the big picture”., • Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required. Candidate represents Evergreen Theragnostics’ to external organizations and must exhibit the highest levels of personal integrity, quality, and professionalism., • Travel may be required and is dictated by product needs and project deliverables, including overnight travel to Evergreen Theragnostics and CDMO locations.

Company Description Stira Pharmaceuticals is a sterile injectable CDMO based in Fairfield, NJ. We specialize in pharmaceutical product development and manufacturing of small molecules and peptides. Our services span Analytical R&D, Formulation Development, Regulatory Support, and more. Backed by a team of highly skilled scientists, Stira brings deep technical expertise and a proven track record in developing complex and challenging products. Role Description Stira Pharmaceuticals is seeking a meticulous and experienced Quality Control Data Integrity Specialist to join our Quality Control team in Fairfield, NJ. This full-time, on-site role is responsible for safeguarding the integrity, accuracy, and compliance of data generated from QC testing. The successful candidate will play a critical role in ensuring that all QC documentation meets Good Manufacturing Practice (GMP) requirements and regulatory expectations, with a particular focus on cross-validation using orthogonal analytical techniques. Key Responsibilities • Review raw QC data for completeness, accuracy, and compliance with GMP and regulatory standards., • Verify that QC test methods and protocols are consistently followed and align with approved specifications., • Ensure data integrity for results generated from advanced analytical platforms, including HPLC, GC, FTIR, UV-Vis, LC/HRMS, ICP-MS, and other orthogonal techniques., • Critically evaluate data by confirming results through orthogonal testing approaches, ensuring robustness and reliability of conclusions., • Identify, document, and resolve discrepancies, deviations, or errors in QC records; collaborate with laboratory staff to implement corrective and preventive actions., • Ensure accuracy and completeness of QC documentation, including laboratory notebooks, instrument logs, and certificates of analysis., • Partner with Quality Assurance and Regulatory Affairs to uphold data integrity and compliance across submissions and inspections., • Review and approve QC documentation to support material and product release., • Support internal audits and regulatory inspections by maintaining ready access to accurate QC records., • Provide training and guidance to QC staff on data integrity principles, documentation practices, orthogonal method utilization, and regulatory compliance., • Stay current with evolving regulations, industry guidance, and best practices in QC data integrity and orthogonal testing. Qualifications • Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field., • Minimum 3 years of QC data review or data integrity experience within the pharmaceutical or biotechnology industry., • Strong knowledge of GMP, GLP, and applicable global regulatory requirements., • Hands-on experience with QC analytical techniques such as HPLC, GC, FTIR, UV-Vis, LC/HRMS, ICP-MS, and other orthogonal technologies., • Demonstrated ability to apply orthogonal techniques for data confirmation and cross-validation., • Exceptional attention to detail with a strong focus on data accuracy and integrity., • Strong organizational and time management skills; able to manage multiple priorities effectively., • Excellent communication and interpersonal skills for cross-functional collaboration., • Proficiency with Laboratory Information Management Systems (LIMS) and electronic data systems preferred., • Familiarity with regulatory submissions (ANDA, IND, NDA) is a plus.

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 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 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 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 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 Description MRI Technician 37 N Fullerton Ave, Montclair, NJ 07042, USA Job Summary: MRI technician to be responsible for providing clear images to Physicians through MRI scanning. The MRI technician's responsibilities include following Physicians' instructions, explaining the MRI procedure to patients, selecting software options and imaging parameters on the MRI machine, viewing images from the imaging session, and keeping records of reports. To be a successful MRI technician, you should have strong communication and interpersonal skills, and be sensitive to the needs of the patients. You should show attention to detail and be able to work in a team. MRI Technician Responsibilities: • Explain the breast MRI procedure to patients., • Ensure all safety questions are asked and consent forms signed before scanning., • Position the patient properly to capture clear images of the breasts., • Start IVs for the MRI process., • Draw blood for genetic testing., • Maneuver the MRI equipment and positioning it to capture the correct images., • Monitor patients during scanning and maintaining patients' records., • Monitor MRI equipment functions., • Ensure clear images for Physicians to provide accurate diagnoses., • Recognize abnormalities and irregularities in images., • Assist radiologist with MRI biopsies, MRI localizations and DynaCad system., • Centricity EMR – entering reports and chart documentation., • Quality Assurance- daily and weekly Qualifications: • Strong communication and interpersonal skills., • RT/ MRI certified/ IV certified., • Current State License and ARRT registry, • Experience with Breast MRI would be a plus.

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 Ultrasound Technician 37 N Fullerton Ave, Montclair, NJ 07042, USA Req #327 Thursday, December 19, 2024 Job Summary: Montclair Breast Center is seeking an Ultrasound Technician, or Sonographer, is responsible for using ultrasound equipment to help visualize internal anatomy functions. Their duties include calibrating and manipulating ultrasound equipment to conduct appointments, taking pictures or videos of potential abnormalities and discreetly notifying medical personnel if they identify something concerning. Essential Functions: The duties of an Ultrasound Technician go beyond diagnosing ailments. Other responsibilities include: • Use sonographic equipment to identify and observe the area(s) of concern, • Prepare the exam room for examinations and assist Radiologists with vascular ultrasound procedures and ultrasound-guided biopsies, • Report to the appropriate medical staff of any abnormalities that require immediate attention, • Maintain sonography equipment and report machinery failure, • Conduct scan tests and write reports based on the results, • Manage several patients and priorities and be able to adapt to a fast-paced work environment, • Work under minimal supervision and cooperate with other team members, • Make and download outside CD’s, • Quality Assurance on equipment., • Also see attached Flat Field Digital QC Tests 2000DS, Flat Field Digital QC Test Essential, and QA Assurance Policy. Qualifications: • Current State License and ARRT registry, • Specialized training in mammography (continuing education/certificates), • Continuing education- this requirement specifies that an average of 5 ECE’s/year be specific to mammography), • Continuing experience in mammography (effective 4/1999)Company DescriptionGenesis Global Group is a privately held collection of vertically integrated domestic and international companies that delivers deep expertise, objective solutions, customized products and unparalleled service spanning the sectors of biotechnology, health care, manufacturing, real estate, and hospitality.Genesis Global Group is a privately held collection of vertically integrated domestic and international companies that delivers deep expertise, objective solutions, customized products and unparalleled service spanning the sectors of biotechnology, health care, manufacturing, real estate, and hospitality.

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 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 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 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 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 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 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 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 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 Description About Tonix* Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Please visit for specifics on the pipeline. *All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication. About the Role The Senior Manager, Validation, situated within the Quality Assurance department, will provide quality support on validation activities for internal and external (i.e., contract organizations) GxP computer systems and data integrity processes. This position will be responsible for ensuring equipment and systems are in an operational state of compliance associated with cGMP manufacturing environments, GxP requirements, and internal policies. They will ensure consistent application and maintenance of Validation procedures This position will collaborate cross-functionally for on-going activities in support of validation activities occurring both internally and at Tonix contracted organizations including support of risk assessments, deviations, CAPAs, and change controls. The Senior Manager, Validation, will lead, direct, and advise continuous improvement of the department’s area of control, and assist in any other area as needed or directed by management. Essential Duties • Ensure the validated status of GxP computer systems used to support GxP activities, is established in accordance with internal procedures, regulatory requirements and industry guidance / standards., • Define computer system validation policies and overall strategies and ensure compliance and consistency with regulatory requirements and best industry practices., • Responsible for maintaining the CQV and CSV programs in a state of compliance., • Establish and provide quality and technical input on the development of policies, procedures, standards and templates, • Review and approve technical documents throughout the equipment/system lifecycle from commissioning, qualification and/or validation through decommissioning, including validation plans, risk assessments, test protocols and reports., • Develop validation and testing strategies based on system risk, complexity, and other relevant factors and ensure all validated systems and documentation comply with applicable regulatory requirements., • Assist with the development of system requirements and specifications to ensure requirements are testable and 21 CFR Part 11 requirements are met. Implement and ensure effective data integrity controls and practices., • Evaluate proposed changes to validated computer systems and recommend the level of validation activities required., • Manage and perform all Quality System functions for the department including impact assessments, deviations, CAPAs, change controls, SOP revisions, and audit responses., • Participate in regulatory inspection, internal audits, supplier audits (as needed), and audit response activities., • Must comply with all applicable rules and regulations of Emergent and Pharmaceutical/Biotech industry. This includes FDA regulations such as cGMP, GDP, EH&S regulations, and company regulations. Will maintain an awareness of regulatory and industry best practice trends, hot topics and changes in relation to validation., • Define and communicate metrics used to track performance relevant to the operations qualification programs’ activities / responsibilities and ensure commitment to key stakeholders and company goals are met., • Proficiency with Quality system applications (e.g., eDMS, QMS), • Dedicated team player who is able to withstand the high demands of a fast-paced environment., • Results driven, problem solver, and collaborator Excellent written and verbal communication skills, • Excellent planning and time management skills and the ability to handle several tasks simultaneously., • Comfortable working independently with minimal supervision, • Ability for travel up to 20% of the time, • Must be able to provide clear direction while motivating teams., • 10+ years of experience in the biotech industry and 2+ years of management experience., • Demonstrated knowledge of cGMPs for biotechnology, validation-related topics, and key industry validation approaches (e.g., validation lifecycle approach, ASME BPE, PIC/S ISPE Baseline Guides ASTM E2500, GAMP 5, V-model, etc.). Complementary knowledge of biopharmaceutical and process engineering principles and practices., • Demonstrated experience in IT System/Software Development Life Cycle (SDLC), change controls, validation needs, and activities., • Demonstrated expertise in Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and knowledge of applicable Codes of Federal Regulations as they apply to computerized systems, e.g., GxP, validation, 21 CFR Part 11, CSA, etc., • Strong understanding of ICH Q7, Q8, Q9, Q10 and other international regulatory guidance is critical., • Experience with personnel management and development., • Strong project management skills., • Working knowledge in Facility, Utility & Equipment Qualification, Process Validation, and Quality System Management. Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $100,000 to $170,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs, • Pet Insurance, • Retirement Savings 401k with company match and annual discretionary stock options, • Generous Paid Time Off, Sick Time, & Paid Holidays

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 .

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

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 X-Ray Technician Montclair, NJ, USA• 37 N Fullerton Ave, Montclair, NJ 07042, USA Job Description Job Summary: X-ray technician to be responsible for providing clear images to Physicians through bone density scanning. The X-ray technician's responsibilities include following Physicians' instructions, explaining the procedure to patients, selecting software options and imaging parameters on the Bone Density machine and keeping records of reports. To be a successful X-ray technician, you should have strong communication and interpersonal skills and be sensitive to the needs of the patients. You should show attention to detail and be able to work in a team. MBC is seeking full-time or part-time X-ray Tech. X-Ray Technician Responsibilities: • Explain the bone density procedure to patients., • Ensure all safety questions are asked and consent forms signed before scanning., • Position the patient properly to capture clear images of the body., • Maneuver the Bone Density equipment and positioning it to capture the correct images., • Monitor patients during scanning and maintaining patients' records., • Monitor Bone Density equipment functions., • Ensure clear images for Physicians to provide accurate diagnoses., • Cleaning and performing routine maintenance tasks to keep X-ray equipment operating smoothly, • Quality Assurance- as needed, • Commitment to patient safety and confidentiality, • ARRT registry preferred, • Computer skills We Offer: • Competitive Salary, • Medical, Dental & Vision Insurance, • Short and Long Term Disability, • Life Insurance, • 401(k) Plan, • Paid Vacation & Holiday Visit us at Montclair Breast Center is an equal opportunity employer. Job Details Pay Type Hourly Company DescriptionGenesis Global Group is a privately held collection of vertically integrated domestic and international companies that delivers deep expertise, objective solutions, customized products and unparalleled service spanning the sectors of biotechnology, health care, manufacturing, real estate, and hospitality.Genesis Global Group is a privately held collection of vertically integrated domestic and international companies that delivers deep expertise, objective solutions, customized products and unparalleled service spanning the sectors of biotechnology, health care, manufacturing, real estate, and hospitality.

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 DescriptionQuality Assurance Compliance SpecialistAllendale, 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 Compliance. Responsible to perform Quality Assurance Compliance activities in support of Quality Systems 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 provide guidance through all stages of the investigation / CAPA processes., • Develops and communicates investigation strategy to key stakeholders., • In order to close investigation and CAPA, collect necessary information from appropriate department to close in quality system and maintain investigation and CAPA log, • Reviews and approves investigations and CAPAs;, • Conducts weekly status update meetings with cross functional departments and other stakeholders., • Monitors DR/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review to management on periodic basis., • 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., • Functional/Technical Skills: has the functional and technical knowledge and skills to do the job at a high level of accomplishment., • Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions., • Drive for Results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results., • Written Communication: Able to write clearly and succinctly in a variety of communication settings and styles., • Peer Relationships: Quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.REQUIREMENTS, • BS biological sciences or other relevant field of study., • 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., • Minimum Required Training (optional); GXP training, SOP & WI training, Safety Training, • Understanding and comprehension of quality system applications.Working Environment 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.Small breakroom available. No on-site cafeteria available.Able to utilize equipment in manufacturing are as well QC laboratories.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 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.

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 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 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 DescriptionQuality Control Manager The Quality Control (QC) Manager plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that quality standards are upheld for all products produced at the facility. The goal is to ensure that the Quality Control group and company is constantly moving towards fulfilling its short-term and long-term objectives and does not diverge from its strategic guidelines. Under the direction of the VP, Global Quality Head, responsibilities of the QC Manager will include but are not limited to: • Leading, hiring, developing, training, and evaluating QC personnel, • Devising sound hiring strategies based on business needs, • Supervising and overseeing QC personnel in their roles for safe and efficient verification, approval, release/disposition of HCATS and/or client products/materials, • Delegating responsibilities and supervising the work of laboratory personnel, while providing guidance and motivation to drive maximum performance, • Ensuring and promoting compliance with applicable cGMP and GTP regulations, while ensuring compliance with company and client methodologies, • Assuring alignment and efficient continuity in laboratory practices between sites, • Serving as approver in investigations while overseeing timely closure of deviation reports, change controls, CAPAs, and applicable batch records, • Ensuring completion of all client QC requirements related to GMP cellular products and/or materials, • Overseeing QC role in material dispositions via deviation reporting system, CoAs, and/or client-based systems, if applicable, • Prioritizing, scheduling, and managing multiple projects and resources simultaneously, • Monitoring effectiveness of quality systems, change control activities and their completion, for both, internal and client audit findings, • Evaluating and investigating customer complaints and deviations; coordinating corrective and preventive actions as they relate to the Quality Control function, • Delegating maintenance, tracking, and trending aspects of the deviation reporting system, • Developing and maintaining Key Performance Indicators (KPIs) for laboratory testing, • Interfacing with vendors, suppliers, and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies, when applicable, • Interfacing with management at all levels for alignment on significant deviation resolution and corrective action implementation, • Delegating development, revisions, and implementation of Standard Operating Procedures as related to Quality Control activities, • Participating in and tracking group budget setting and cost containment drives, • Communicating and maintaining trust relationships with senior management, business partners, and clients, • Ensuring company policies and legal guidelines are communicated top-down in the company and that they are followed at all times, • Completing projects and special tasks as assigned by the Global Quality Head, • Off-schedule shifts during weekends and holidays based on business requirements a possibility, • On-call presence preferred while physical personal presence is not possible, • Candidate will oversee QC Scientist and QC Associate I, II, and III roles. The QC Manager will delegate responsibilities to direct reports to achieve the requisite business needs, while providing ongoing support to Manufacturing processes.REQUIREMENTS, • BA/BS/MS in a science or relevant field required, • Master’s in Business Administration or relevant field will be preferred, • 7 – 10 years’ experience in the pharmaceutical, biologics or related industry, • Prior cGMP experience required, • Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment a must, • Experience in Flow Cytometry is a must, • 5 + Years experience leading a team is a must. Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff, • Sound understanding of current Good Manufacturing Practices (cGMPs), • Working knowledge of routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, equipment and systems, and understanding of production processes and validation, • Prior experience with reviewing Standard Operating Procedures, work instructions, protocols, methods, method validations preferred, • Proven experience in a supervisory or managerial position, • Demonstrable experience in developing strategic plans based on business needs, • Strong understanding of Quality Control in pharmaceutical/biotechnology/biologics industries, • Thorough knowledge of market changes and forces that influence the company, • Proficient with computer software: Microsoft Office, Visio, • Strong written, oral, and presentational skills, • Strong knowledge of QC Analytical testing methodologies, philosophies, method validation and method transfers, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review, • Excellent organizational and leadership skills, • Excellent communication, interpersonal, and presentation skills, • Outstanding analytical and problem-solving abilities, • Strong business acumen, • Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner, • 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 responsibilitiesWhile 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 clientsMust 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 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.