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Job DescriptionDescription: RK Pharma Inc, a US based company with subsidiaries in India, is seeking multiple manufacturing associates to help support our existing manufacturing line in efficient producing products for our clients. As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, detail-oriented individuals to help us grow our mid stage start up team. Requirements: If this sounds interesting to you, it’s probably because up to this point you have: • Worked in scientific manufacturing or have recently graduated from an engineering, life sciences or technical school and are looking to start your career., • You are organized and detail oriented but dread the thought of being tied to a desk all day., • Learn processes and procedures quickly and are excited to contribute to making them more streamlined and efficient., • Thrive in environments that are focused on being clean and organized. The main responsibilities for this position are: • Updating documentation of Batch Record, logbook and other related documentation with detail and accuracy., • Adhere to all aseptic practices and standard operating procedures by training and through on-the-job training., • Execution of compounding, filtration, filling, other unit operations like qualification, supporting operational activities as per Master batch records, Qualification protocols, Process validation protocols., • Writing all QMS documents and SOP preparation/ revisions time to time., • Other duties as assigned. CRITICAL REQUIREMENTS: MUST BE ABLE TO LIFT UP TO 50 LBS. AND ABLE TO STAND MOST OF THE WORKDAY MUST BE ABLE TO WORK A FLEXIBLE SCHEDULE INCLUDING NIGHTS AND WEEKENDS WHEN NEEDED. If this sounds like something that is of interest to you, please don’t hesitate to apply to start a conversation. We look forward to getting to know more about you and the skills you can bring to a company like RK Pharma Inc.

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.

Job DescriptionMedical Manufacturing Company Urgently Hiring Quality Inspectors Location: Allendale & Oakland, NJ Position: Quality Inspector Shift: 7am-3:30pm (Monday-Friday) Pay: $21-$23/hour ; Overtime: $31.50-$34.50/hour Please apply now and can be set up with an interview and start a career opportunity! Job Description We are seeking a dedicated Quality Inspector to conduct visual inspections of manufactured and packaged products. The ideal candidate will have experience in a GMP environment and will be responsible for maintaining an adequate inventory of manufacturing supplies, as well as requisitioning additional materials as needed. You will also conduct end-of-process inspections within the warehouse, work directly with the shipping team, document final inspection findings, help create lot numbers, and return final products to shipping. Responsibilities • Perform visual inspections of manufactured and packaged products., • Maintain inventory of manufacturing supplies and requisition additional materials as needed., • Conduct end-of-process inspections within the warehouse., • Collaborate with the shipping team and document final inspection findings., • Experience in a GMP environment., • Ability to read and follow Standard Operating Procedures (SOPs)., • 2+ years in medical device, nutraceutical, or pharmaceutical production environment., • Proficiency in packaging, GMP, document control, labeling, and inspection., • Good verbal and written communication skills., • Experience in a cGMP environment or clean-room. 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 Oakland,NJ. Application Deadline This position is anticipated to close on Dec 23, 2025. About Aerotek: We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meets their goals, skills and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role solving for companies’ construction, manufacturing and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are everything spirit to the test as your career continues to grow. Aerotek offers weekly pay, employee benefits including medical, dental & vision, life insurance, health advocacy and employee assistance programs, a 401(k) plan, and employee discounts. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. Company DescriptionWe know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meet their goals, skills, and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role in solving companies’ construction, manufacturing, and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are-everything spirit to the test as your career continues to grow.We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meet their goals, skills, and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role in solving companies’ construction, manufacturing, and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are-everything spirit to the test as your career continues to grow.

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.

Job Description Responsible for a portfolio of customers in the pharmaceutical packaging industry. The successful candidate will work in a multicultural environment in a NYC based office, under the supervision of the Customer Service Manager. The position involves administering customer orders in an SAP computer system, coordinating manufacturing schedules with our plants (in EU and Asia) and delivery schedules with our Logistic partners, updating the forecast and supporting the Sales Managers within a specific customer portfolio. Building report and Clear communication with the customer base are the most critical functions. The Customer Service Representative will be engaged in facilitating account administration such as ensuring on time payments and inventory control. ESSENTIAL DUTIES AND RESPONSIBILITIES • Manage all ordering and logistic communication with client portfolio, • Create and maintain clients’ accounts in SAP (new customer, price list, cross reference lists, surcharges), • Maintain administrative files (Network/CRM: orders, paperwork, POs status), • Update the forecasting tool to ensure all data are accurate, • Sales support (Samples, new development), • Late payment (reminders level 1, fill in tracking document), • Control and manage inventory in local US warehouse (when applicable) EDUCATION AND EXPERIENCE • Minimum of 2 years of trade school (with appropriate experience) or university degree in related subjects to job description., • Good communication skills (oral and written), • Team player, organized, detailed oriented, quick learner, • Comfortable in a multicultural, multilingual environment, • Spanish and French prerequisite COMPUTER SKILLS • Very comfortable with IT tool (ERP system, forecasting tool, Microsoft Office suite). SAP experience is a plus

Job Description 1 Shift available: Monday through Thursday 2nd Shift: 4:30pm to 2:40am; mandatory over-time on Fridays. Full time regular openings for a Finishing Operator. The finishing operator is responsible for set up and operation of inspection and slitting equipment - this includes the usage of computerized camera systems, manual or automatic slitting systems; Ink Jet Equipment for Numbering Essential Functions include the following (Other duties may be assigned): • Completing all necessary paperwork and inspects the order in accordance with Quality Assurance procedures, • Checking for correct copy of the label order using a computerized vision system, • Set up of finishing machine - including web tensions, ink jet system, knife position (by hand or automatic), • Splices out any inferior printed material, • Verifies that all finishing customer specifications are followed, • Packs the finished reels onto carts and applies all required identification, • Communicates with the supervisor on quality issues, • Ability to read and comprehend instructions, short correspondence and memos, • Attention to fine detail and to work to deadlines, adhering to strict customer requirements, • Ability to use a calculator, • Able communicate in English verbally and writing, • Critical thinking Skills (Problem solving, observation, analysis), • Basic mathematical skills including addition, subtraction, multiplication and simple division, • Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals, • Basic Technical knowledge and ability to trouble shoot The operator position requires the employee to regularly stand, reach with arms, kneel and lift up to 50 lbs. Applicants must have a high school diploma (or General Equivalent Degree) or higher level of education and at least 1 year experience in operating manufacturing equipment. Vision abilities including close vision, peripheral vision, depth perception, and the ability to adjust focus

Job Description Travel Operations Manager 120-130K, Hybrid. Liberty Personnel is partnered with a Top AM Law Firm seeking to add an experienced Travel Operations Manager to their team. Responsibilities • Oversee general travel coordination and serve as a point of contact for routine travel-related inquiries., • Support the implementation and maintenance of travel guidelines, tools, and procedures., • Liaise with travel vendors, internal departments, and administrative teams to facilitate consistent service delivery., • Monitor travel requests and related workflows to help ensure accuracy and alignment with firm expectations., • Bachelor's Degree or relevant experience required., • 4+ Years of Travel Management within a law firm or professional services environment strongly preferred., • Strong organizational and communication skills with the ability to manage multiple moving parts. Hundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month. Established in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on: Information Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.Libertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move!\n\nHundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month.\n\nEstablished in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on:\n\nInformation Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.

Job Description Labor & Employment Counsel Hybrid - Must live locally - 1 time a month onsite Travel 20% Overview Our client is seeking an experienced Labor & Employment Counsel to provide strategic and day-to-day support across multi-state and international operations. Key Responsibilities • Lead union strategy, negotiations, grievances, and arbitrations., • Manage relationships with unions, works councils, and labor agencies., • Advise on workforce planning, restructures, RIFs, onboarding/offboarding, and contingent workforce models., • Support M&A due diligence, integrations, and CBA transfers., • Deliver manager and HR training on labor relations, investigations, and compliance., • Partner with Operations and HSE on staffing models and labor compliance for large-scale events., • Review labor-related terms in vendor and client contracts., • JD and active bar membership required., • 7–12+ years of labor and employment experience (law firm or in-house)., • Must have Union experience, • Strong background in union/collective bargaining and NLRB or agency practice., • Multi-jurisdictional experience; hospitality, sports, or events industry a plus., • Excellent negotiation, communication, and stakeholder management skills. Senior Recruiting Manager Liberty Personnel Services, Inc. 1001 Conshohocken State Rd, Ste 2-410| West Conshohocken, PA 19428 |Please connect with me on LinkedIn Company DescriptionLibertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move! Hundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month. Established in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on: Information Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.Libertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move!\n\nHundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month.\n\nEstablished in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on:\n\nInformation Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.

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

Job Description Sr. Auditor Quality Assurance (Pharmaceuticals) Location: Paramus, NJ (100% On-Site) - 5 month contract Experience Level: Mid-Senior Experience Required: 5+ Years Education Required: Bachelors Degree (Life Sciences or related field) Industry: Pharmaceuticals / Life Sciences Job Function: Quality Assurance / Auditing / Compliance Compensation: Hourly Competitive (rate provided upon request) ️ Relocation Assistance: Not Provided Visa Sponsorship: Not Available Position Summary We are seeking a Senior Quality Assurance Auditor with strong experience in the pharmaceutical or radiopharmaceutical sector. This role is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with GMP, GDP, and other global regulatory standards. The successful candidate will play a critical role in upholding our Pharmaceutical Quality System (PQS) and ensuring inspection readiness across operations. Key Responsibilities * Conduct internal audits, supplier audits, and contract manufacturer (CMO) audits including routine, for-cause, and risk-based. * Develop and manage audit plans, schedules, and checklists based on regulatory guidelines and internal SOPs. * Assess compliance with FDA, EMA, ICH, and international GMP/GDP regulations. * Review and evaluate deviations, CAPAs, and change control records. * Generate detailed audit reports and communicate findings to internal and external stakeholders. * Track CAPA implementation and verify effectiveness through follow-up assessments. * Support regulatory authority inspections and third-party audits. * Provide expertise on quality and compliance-related matters, promoting audit readiness culture. * Identify systemic gaps, recommend improvements, and drive continuous quality improvement initiatives. * Stay current on regulatory changes, industry trends, and quality system best practices. Required Qualifications Bachelors degree in Life Sciences, Pharmacy, or a closely related field 5+ years of pharmaceutical QA experience (with at least 2 years conducting audits) Proven understanding of GMP, GDP, and radiopharmaceutical (RPT) compliance Familiarity with global regulations including FDA, EMA, ICH Excellent documentation, communication, and analytical skills Ability to travel up to 10% for audits (domestic and potentially international) Preferred Certifications ASQ Certified Quality Auditor (CQA) ISO 9001 Lead Auditor Certification GCP/GMP Auditing Certifications Why You Should Apply If you're looking to leverage your audit and compliance skills in a growing, highly specialized sector like radiopharmaceuticals, this role offers the ideal opportunity. You'll work in a critical QA function with visibility across manufacturing, testing, and supply chain operations, helping to uphold product integrity and patient safety. This is a high-impact position where your attention to detail and regulatory expertise will directly contribute to maintaining compliance, improving systems, and supporting global quality standards. Whether you're looking to step into a senior auditing role or expand your influence across a broader QA landscape, this opportunity provides the structure, challenge, and responsibility to help elevate your career. Apply now to join a team committed to excellence in pharmaceutical quality and make a difference in the future of healthcare.

Our pharmaceutical client is seeking a Site Account Specialist on a long-term contracting basis This is a hybrid position based in Madison NJ Overview: The Site Account Specialist, Scheduling and Cell Logistics will be responsible for scheduling and monitoring patient treatment schedules for the manufacturing of the Company’s commercial autologous cellular immunotherapy products. They will serve as the Company's cell therapy treatment centers main point of contact for patient scheduling. The primary duty of the Site Account Specialist, Scheduling and Cell Logistics is to execute day-to-day operations ( 95% of time). Participation in projects and working groups is a growth opportunity as operations permit, considering performance and alignment with development plan. Duties and Responsibilities: • Act as primary scheduling point of contact for assigned treatment sites, • Create and maintain patient schedules in coordination with treatment sites and manufacturing sites, • Troubleshoot and develop plans of action for issues throughout the patient journey, • Interact with internal and external stakeholders over the phone and email, • Ensure a positive end-to-end customer experience, • Execute exception processes such as product returns, product replacements, and out of spec product, • Input and maintain transactional data related to patient schedules within clients’ scheduling system, • Train treatment sites on patient scheduling processes as assigned, • Document feedback from customers and partners as received, • Create and maintain master data in account management system, • Actively participate in tactical and other meetings as assigned, • Facilitate daily operations activities and meetings including shift turnover on rotating basis, • Provide real-time scheduling portal support to external users, • Lead meetings with commercial matrix teams, • Raise escalations and execute as assigned, • Track assigned account health and provide insights into trends, • Comply with applicable SOPs, work practices, and other documentation, • Establish and maintain a trusted relationship with commercial matrix team and treatment sites as assigned, • Accountable for individual performance, • Execute project tasks as assigned, • Execute working groups tasks as assigned Required Competencies: • Bachelors degree or 3 years of work experience, • Work experience in customer service, call center operations, patient services/navigator, account management, logistics, or supply chain preferred, • Highly self-motivated, self-aware, and professional, • Able to work independently and in groups, • Flexible in responding to quickly changing business needs, • Exceptional customer service orientation, • Skilled at managing tense situations and de-escalation, • Eager to work with teams from other regions and cultures, • Able to share workspace for independent and collaborative work, • Strong sense of ownership and accountability, • Position shift time is 8am 5 pm local., • Overtime may occasionally be required as assigned., • Holiday support is required as assigned., • Travel is possible and will not exceed 10%. International travel will not exceed once per year. Pay: 31-33/hr. Job #83955

Job Description This is a fantastic opportunity to join Luminance, the pioneer of Legal-Grade™ AI for enterprise. Backed by internationally renowned VCs and named in both the Forbes AI 50 list of ‘Most Promising Private AI Companies in the World’ and Inc. 5000’s ‘Fastest Growing Companies in America’, Luminance is disrupting the legal profession around the globe. Off the back of a $75 million Series C funding round, this is a unique opportunity to help spearhead Luminance’s sales team, leading a team of Account Executives and working with businesses spanning every sector, from major manufacturing companies and high growth technology companies to global retailers and pharmaceutical giants. As a Commercial Director you will lead, manage, and motivate an enterprise sales team to achieve key metrics and deliver exceptional results. You will also oversee the end-to-end sales process, including prospecting, lead generation, qualification, proof-of-value (POV) design/deployment, proposal development, negotiation, and closing deals. In addition, you will be key in developing and executing comprehensive sales strategies that align with Luminance's global business objectives. Responsibilities • Leadership - Provide coaching, guidance, and professional development opportunities to individual AEs; assist in recruiting, staffing, and onboarding activities to grow and maintain a high-performing team., • Sales Planning - Identify market opportunities, competitive landscape, and customer needs to drive sales growth., • Process Management - Collaborate with internal teams to ensure seamless execution and delivery of Luminance's technology; identify gaps and propose ongoing process improvements to enhance efficiency., • 2+ years of recent experience leading enterprise or commercial/mid-market sales reps in a fast-paced environment., • 5+ years of full-cycle, B2B sales experience; a successful track record of winning new business at the enterprise and strategic level., • Demonstrated success in forecasting, territory account mapping, research and planning and running discovery meetings for key/strategic accounts., • Excellent communication skills; the ideal candidate will be a natural, confident and articulate storyteller with the ability to articulate complex ideas and engage varied audiences with ease., • Ability to work autonomously while also collaborating with multi-disciplined teams. Very competitive OTE (total package open to consideration, subject to experience)

Job DescriptionA World-Changing Company Palantir builds the world’s leading software for data-driven decisions and operations. By bringing the right data to the people who need it, our platforms empower our partners to develop lifesaving drugs, forecast supply chain disruptions, locate missing children, and more. The Role The Palantir Design Team is responsible for the human experience of using our software. Our team is growing rapidly, but we're committed to creating a tight-knit team environment that fosters trust, integrity, empathy, and growth. We work together in realizing a shared product vision, and regularly give feedback and critique to each other. Designing at Palantir is a varied experience. On a given day, you might be: leading a design sprint for your product team; designing a micro-interaction to make a complex analytical task feel simple; and/or advocating for UX consistency by creating flexible, reusable UI components. Designers at Palantir develop a deep understanding of the problems our customers face while solving some of the world’s most unique challenges. Our mission is to build generalizable and scalable solutions that elegantly handle the complexity of these problem spaces.Core Responsibilities • Interaction and visual design. As a product designer, you'll be involved at every stage of design work. You'll help define early product concepts, flesh out the high-level workflow and micro-interactions of a feature, and execute on a crisp and effective visual design. You should have experience designing and prototyping using tools such as Figma., • User research. We frequently do informal user research, and value people who can be flexible with research processes and methodologies to achieve the right outcome. You'll often visit customer offices to interview and learn from the users we serve. You'll pair qualitative methods (e.g. scripted usability tests and contextual inquiry) with quantitative information, like product and usage metrics., • Deliver and communicate designs in close collaboration. We work closely with product and forward deployed engineers to realize our design ideas. You'll treat engineers and product managers as partners and collaborate with them to prototype and build out products., • An iterative design process. You validate your ideas early (with stakeholders and users) and are thoughtful and intentional in seeking and responding to feedback. You move fast, listen, and adapt. You rapidly incorporate feedback, and prioritize collaboration. You are adept at giving and receiving critiques., • Collaboration and communication. You can build great relationships with engineers, PMs, and other stakeholders—and convey your design rationale to them. To reach these audiences, you'll communicate your designs through a variety of methods: presenting your mockups, making prototypes, sharing a design spec., • Thoughtful, intentional work. You know that form informs function and usability—that the surface layer doesn’t exist in a vacuum. Your design decisions are often informed by—and will influence—engineering and business considerations., • Dedication to the user. You'll design software that changes how people use data in government and commercial contexts. You strive to understand our users—who can range from a manufacturing plant worker to a pharmaceutical researcher—and fight to empower them., • Excitement for solving hard, complex problems. You are excited to design for technically complex and data dense interfaces.You thrive in an environment where you can jump into deep subject matter expertise to define simple, approachable, yet still powerful product experiences.What We Require, • Active US Security clearance or eligibility and willingness to obtain a US Security clearance.

Job Description About Lantheus Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. Today, we’re expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world. At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We’re dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress. Join us and be part of a company where your contributions make a real impact, because we know someone’s health is in our hands. This role will be based at Evergreen Theragnostic, a Lantheus company, located in New Jersey, requires a presence on-site four days per week, and is and open to applicants authorized to work for any employer within the United States. Responsibilities The Associate Director, Technology Development and Transfer, acts as a technology development and transfer lead in the Tech Ops organization. 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. 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. Additionally, this role: • 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 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., • 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., • 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. The ideal candidate will embody Lantheus core values: • Let people be their best, • Respect one another and act as one, • Learn, adapt, and win, • Know someone’s health is in our hands Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until January 10, 2025. Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law. Lantheus is an E-Verify Employer. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at .

Job Description The Press Operator is responsible for the safe and efficient operation of a press while adhering to customer specification, quality requirements, company standards, and guideline and safety standards. This position is responsible for the overall completion of the job assigned to the Press Operator 2nd shift 4:20pm - 2:40am Monday - Thursday. Mandatory over-time on Fridays. The Screen Printing Operator plays a crucial role in the production process within the wholesale trade industry, specifically focusing on the creation of high-quality printed materials. This position involves operating and maintaining screen printing equipment to ensure that all products meet the company's quality standards and client specifications. The operator will be responsible for setting up screens, mixing inks, and executing print runs efficiently while adhering to safety protocols. Attention to detail is essential, as the operator will inspect finished products for accuracy and quality before they are shipped to clients. Ultimately, the success of this role contributes to the overall satisfaction of customers and the reputation of the company in the market. • Inspections of printed material to ensure the correctness in all areas of color, registration, stock, and all other customer specifications., • Adjusting and maintaining registration, color, perforations, and other customer specific printing specifications., • Observes the press operations to detect any machine or equipment malfunctions and moves to correct the issues., • Makes adjustments to all press machine parts and equipment: feeders, grippers, guides, feed wheels, cameras, and other machines parts, using proper equipment., • Conducts a visual inspection prior to printing of all material stock and ink for defects or noncompliance to job specifications., • Carries out the final inspection to ensure the material, ink, plates or screens, cylinder/rollers, tension, and all other necessary customer specifications are correct prior to the start of the running the job., • Review and interpret job specifications and work order instructions, delegates or carries out directions as needed., • Ensures all job-related data (time and material) are entered into the ERP system (DISO)., • Ensures all unused material goes back to the designated area after each job is finished running., • Knowledge of cGMP, ISO and Lean Manufacturing is a plus. Reading, analyzing, and interpreting technical procedures, manuals and manufacturing documents including the system of Graphic specification/Graphic identical/Articles., • Experience with inks and material., • High School Diploma or General Equivalent Degree (GED), • Experience with handling and proper caring of die cutting tools., • Experience with machine set-up, • Experience with UV and water-based inks preferred., • Experience working with vision systems preferred., • Working knowledge of quality procedures in the pharmaceutical industry preferred., • Ability to lift 50 pounds., • Standing for long periods of time., • Work activity requires repetitive bending, reaching, walking, stooping, and crouching, lifting, and climbing.

Job Description Who we are: For over 20 years, Global Relay has set the standard in enterprise information archiving with industry-leading cloud archiving, surveillance, eDiscovery, and analytics solutions. We securely capture and preserve the communications data of the world's most highly regulated firms, giving them greater visibility and control over their information and ensuring compliance with stringent regulations. Though we offer competitive compensation and benefits and all the other perks one would expect from an established company, we are not your typical technology company. Global Relay is a career-building company. A place for big ideas. New challenges. Groundbreaking innovation. It's a place where you can genuinely make an impact – and be recognized for it. We believe great businesses thrive on diversity, inclusion, and the contributions of all employees. To that end, we recruit candidates from different backgrounds and foster a work environment that encourages employees to collaborate and learn from each other, completely free of barriers. Your role: As Senior Manager, Healthcare Regulatory Intelligence, you are a market-facing thought leader, leveraging your extensive background in regulation and compliance within highly regulated Life Sciences institutions. Your experience, ideally including roles within regulation, compliance and regulatory governance, will contribute to a distinct team of subject matter experts at Global Relay, enhancing our brand value both internally and externally. Your primary challenge will be optimizing productivity amidst a diverse and unstructured role, requiring flexibility and autonomy. Reporting to the Global Head of Regulatory Intelligence (UK), the role will have regular formal and informal interactions. Supervisory guidance will be available to support your efforts, while allowing for autonomous work. Your responsibilities: Internal responsibilities: • Support and enhance brand awareness for the New York office across all relevant stakeholders, • Provide marketing support by assisting with PR, messaging in collateral, and content for marketing events, that elevate Global Relay's brand recognition, • Assist in business development efforts by participating in key customer meetings and briefings, and be ready to share your subject matter expertise, • Offer support to product teams by advising on market practices, challenges, competitor offerings, and regulatory expectations, • Contribute to Global Relay Intelligence & Practice (GRIP), our business' daily regulatory content service, by writing articles, providing editorial input, and participating in interviews for multimedia content, • Contribute to internal training materials, educating those less familiar with Life Science best practice, and business development teams on market dynamics and compliance processes, • Stay abreast of regulatory changes by regularly consuming and filtering relevant news sources, and disseminating insights across the organization, • Participate in Executive Briefings (extensive prospect and client meetings), collaborating on workshops and product pitches to customers and prospects, • Work in close collaboration with product teams to ensure innovative solutions meet specific compliance requirements and mitigate risks effectivelyExternal responsibilities:, • Host and lead industry roundtables, facilitating discussions on evolving compliance practices and attending social events to engage with compliance officers, • Speak on panels and as a keynote speaker at industry events, representing Global Relay and staying informed about market trends and competitor positioning, • Utilize your extensive network of regulatory and compliance practitioners to raise awareness of Global Relay's capabilities and stay updated on market practices, • Minimum of 10 years of experience in a regulatory or compliance role within the Life Sciences industry (particularly pharmaceutical manufacturing), with a demonstrated understanding of Healthcare and Life Sciences laws and regulations, • Bachelor's degree in a relevant field, ideally with additional certifications or advanced degrees (such as a law degree or CPA), • Familiarity with 21 CFR Part 11, Good Manufacturing Practices (GMP), FDA, EMA, ICH, and DOJ ECCP, • Strong communication skills, both written and verbal, with the ability to articulate complex regulatory concepts clearly and persuasively, • Ability to work autonomously and collaboratively within a cross-functional team environment, demonstrating flexibility and adaptability to changing priorities, • Experience in "mobile device compliance challenges, e.g. ephemeral messaging," as well as SaaS electronic message archiving, compliance, and supervision in highly regulated industries, • Excellent project management skills, including the ability to manage multiple projects simultaneously and drive them to successful completion Global Relay advertises the pay range for this role in compliance with applicable pay transparency laws. Individual pay rates are determined by evaluating factors such as expertise, skills, education, and professional background. The range below reflects the expected annual base salary, which is only one element of our comprehensive total rewards package designed to reflect our company pay philosophy, culture and values. We aim to foster an inspiring work environment and support employees' work-life rhythms. We provide a comprehensive health benefits program, including extended health coverage and short-term / long-term disability insurance. Employees receive annual allotted vacation days, which increase based on tenure. Other benefits include paid sick days, maternity/parental leave enhanced program, commuter benefits, corporate bonuses, and a 401(k)-retirement plan with company contribution matching. For employees based at our New York office, we provide additional perks and amenities to enhance your work experience including a subsidized meal program, courtesy of our in-house culinary team! Base salary range$180,000—$250,000 USD What you can expect: At Global Relay, there's no ceiling to what you can achieve. It's the land of opportunity for the energetic, the intelligent, the driven. You'll receive the mentoring, coaching, and support you need to reach your career goals. You'll be part of a culture that breeds creativity and rewards perseverance and hard work. And you'll be working alongside smart, talented individuals from diverse backgrounds, with complementary knowledge and skills. Global Relay is an equal-opportunity employer committed to diversity, equity, and inclusion. We seek to ensure reasonable adjustments, accommodations, and personal time are tailored to meet the unique needs of every individual. To learn more about our business, culture, and community involvement, visit .

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

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

Job Description About Immuneering: Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. Our lead product candidate, atebimetinib (IMM-1-104) is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. Immuneering’s R&D team is based in a ~38,000 square foot lab and office facility in San Diego. The company also has offices in New York City and Cambridge MA. Immuneering has grown to more than 50+ employees, all working to apply their expertise, passion and creativity to improve the lives of people with serious diseases. Immuneering’s team works collaboratively and relentlessly, thinking across traditional boundaries to help shape the frontiers of drug development. General Summary of Duties: The Director, Regulatory, CMC (Chemistry, Manufacturing, and Controls) is a pivotal regulatory role responsible for developing and executing regulatory strategies for CMC activities across the company’s clinical product portfolio. This position ensures compliance with all applicable regulatory requirements and works cross-functionally to support product development, registration, and lifecycle management. A successful candidate will be a highly collaborative individual with strong interpersonal skills and will be an exceptional team player. Specific Duties, may include but not be limited to the following: · Develop and lead global CMC regulatory strategies for investigational and commercial products to ensure timely submissions and approvals. · Prepare, review, and submit CMC sections of regulatory documents including INDs, IMPDs, NDAs, BLAs, ANDAs, and supplements to FDA, and other regulatory authorities including the EMA. · Provide regulatory guidance on CMC matters to project teams, including manufacturing changes, process development, and technology transfers. · Monitor and interpret current and emerging CMC regulatory requirements, guidelines, and trends to proactively address potential impacts. · Represent Regulatory CMC in cross-functional teams and meetings, providing expertise and input on regulatory implications of manufacturing and quality changes. · Lead interactions and communications with regulatory agencies regarding CMC topics, e.g. pre-IND, end-of-phase, and pre-submission meetings. · Work with a sense of purpose to get work done using influence and good project management skills, fostering alignment with organizational goals. · Collaborate with Quality, CMC, R&D, Finance, Legal, Clinical and other internal departments to ensure regulatory compliance and readiness. Partner effectively and smoothly with CRO’s and consultants. Desired Skills and Qualifications · Bachelor’s degree in Chemistry, Pharmacy, Life Sciences, or related field required; advanced degree (PhD, PharmD, MS) highly preferred. · Minimum of 8+ years of experience in CMC regulatory affairs within the biopharmaceutical or pharmaceutical industry, including experience with small molecule development in oncology. More experience is a plus. · Proven track record of successful CMC submissions and approvals in the US and internationally. · In-depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC. · Strong leadership, communication, and project management skills. · Must be focused on working collaboratively and within our values of: Data rules, All-in, Own it (Accountable), Caring and Humble. · Ability to work effectively in a collaborative, fast-paced environment. Location: Remote or Hybrid, if you live near an Immuneering office, regular Meet Ups are available. Physical Demands/ Working Conditions 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to [X]% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

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 Plant Manager Local HEAVY industrial plant has an immediate need for a Plant Manager with at least 10 years of experience in coal, waste to energy or power generation industry along with a proven background in leadership to oversee the day-to-day operations as well as meeting the long term objectivesEssential Qualifications: • Specifically seeking candidates with solid fuel experience—ranging from coal waste to energy biomass and other solid materials such as wood chips, paper pulp, and nutshells., • The key requirement is hands-on experience with solid fuels., • Proven track record in planning and executing facility outages efficiently, ensuring adherence to Safety, Quality, Delivery, and Cost (SQDC) commitments., • Bachelor's degree in engineering, technical, or business required, • Experience building and maintaining a culture of environmental and safety excellence., • Well versed in environmental compliance, • Develop and manage budgets, • Oversee safe execution of outages, • Proficient in developing sustainable facility budget forecasts to maximize financial contributions., • Provide excellent leadership to encourage a culture of collaboration and safetyCompany DescriptionLibertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move! Hundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month. Established in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on: Information Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.Libertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move!\n\nHundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month.\n\nEstablished in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on:\n\nInformation Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.

Job Description Mechanical HVAC Engineer Respected MEP firm seeks HVAC Engineer for Manhattan location: • 5 to 15 years of MEP experience, • REVIT and AutoCAD skills, • Diverse project experience = corporate, institutional, educational, healthcare, • Full understanding of all mechanical trades = plumbing, sprinklers, • Degree in Mechanical Engineering, • PE license, • Stable employment history with MEP firms #midsenior #HVAC #libertyjobs Company DescriptionLibertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move! Hundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month. Established in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on: Information Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.Libertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move!\n\nHundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month.\n\nEstablished in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on:\n\nInformation Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.

Job Description Company: Scientific Design LLC Location: Little Ferry, NJ Position Title: EHSS Compliance Specialist 2 Explore Scientific Design A career at Scientific Design provides you with an opportunity to leave a lasting positive impact to the world and yourself. We offer a wide range of benefits and offerings that recognize the unique motivations and ambitions of our team. It’s all about matching what matters to you with what matters to us. Scientific Design (SD) makes a global impact on people and their communities by delivering safe, reliable, and sustainable EO-based technologies. We are a Global Leader in the development and licensing of proprietary processes to produce Ethylene Oxide (EO), Ethylene Glycol (EO/EG), Bio-Ethylene, Bio-EO, Bio-EG, EO derivatives, Polyols, and Maleic Anhydride. The chemicals produced by these technologies are the building blocks for a multitude of consumer products that improve the lives and health of millions. In addition to these technologies, SD develops and manufactures innovative proprietary catalysts and equipment to be used in our own industrial processes and those used by our clients. Our Culture is based on four values – Safety, Innovation, Customer Focus and Great Place to Work. These are the foundations of our success. To learn more about these and how we deliver safe, reliable, and sustainable technologies for a better world, please click here. SUMMARY OF POSITION The EHSS Specialist is responsible for leading the day-to-day management of the EHS&S function of Scientific Design with specific responsibility and accountability for all aspects of employee health, safety, environmental compliance, and site security within the Company. This position is under the direction of the on-site EHSS Manager. MAJOR ACTIVITIES AND RESPONSIBILITIES • Ensuring compliance with federal, state and local EH&S-related laws, regulations and rules affecting all aspects of our business under direction of site EHSS Manager., • Effectively and timely communicating and updating EH&S policies and procedures to promote a proactive, solution-oriented approach to employee health and safety, • Leading EHS management system implementation and compliance., • Offering and organizing practical solutions to, and actively participating in, the execution of solutions to EH&S issues which may arise within or pertaining to the Company, • Leading the Company’s commitment to ensuring the safety of our employees, contractors, customers, and community, including developing, modifying, and implementing safety policies and procedures, • Leading and coaching jobs safety analyses within the production, warehouse, and research environments., • Participating in safety reviews regarding process and equipment modifications., • Assisting EHSS Manager with preparing and submitting EH&S-required reports and permits applicable to, and corresponding as required with, regulatory agencies such as EPA, NJDEP, OSHA and DOT, add air, storm water, wastewater discharge, hazardous waste, etc., • Coaching and training employees on EH&S matters relevant to their respective roles within the company, with a focus on manufacturing, research and development, and chemical production processes, logistics, and testing procedures, including hazard analysis, best practices, and root cause investigative techniques, • Supporting strategic initiatives by proactively counseling on EH&S impact, and recommending means, to achieving the goals of the initiatives, • Identifying, establishing, maintaining the data relevant to, analyzing and monitoring metrics to assess, and continuously improving processes for, EH&S compliance and efficiency/effectiveness, • Leading employee safety committees and encouraging participation in safety initiatives., • Ensuring the availability and use of personal protective equipment (PPE)., • Conducting risk assessments and implementing appropriate risk mitigation strategies., • Conducting periodic hazardous waste and storm water compliance inspections., • Other duties as assigned. JOB REQUIREMENTS • Bachelor’s degree, • 1-5+ years of experience in EHSS related roles, • Comfortable working in a team-based environment., • Effective communication and investigation skills (written and oral) to lead practical solution-oriented action items and investigations, • Knowledge of occupational health and safety regulations and standards., • Strong analytical and problem-solving skills., • Excellent organizational and time-management skills., • Ability to work independently and collaboratively in a team setting., • Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint) and EHS incident analysis software. Preferred Skills and experience • Chemical, Science, Engineering, Environmental, or Industrial Hygiene/Public Health degree, • Experience in chemical, pharmaceutical, or food manufacturing, • Experience with and demonstrated ability to effect positive, meaningful change in aspects of EHSS. Positive attitude regarding safety program implementation. Willing to lead teams of cross-functional stakeholders to resolution on incident investigation and audit findings., • Strong training and presentation skills. Applicant must be comfortable learning and leading training courses on Safety and Environmental topics., • Experience in hazard recognition and analysis, control of hazardous materials and chemicals, air and water compliance, storm water management, chemical and material transportation, incident investigation and hazardous waste management (RCRA & DOT)., • Experience with behavior modification techniques and culture change applicable to job hazard and safety matters. Eligibility Requirements • You must be 18 years or older., • Applicants must be currently authorized to work for Scientific Design in the United States on a full-time basis., • Applicants must be medically cleared and able to wear respiratory protection. Work Availability Regular, predictable attendance is an essential function of this position. Applicants must be regularly available and willing to work during assigned hours of operation and other hours as the company determines are necessary or desirable to meet business needs. This position will serve as a critical member of the site’s emergency response team. Comprehensive Benefits Package: At SD, we value our employees and offer a competitive and comprehensive benefits package designed to support your health, well-being, and financial future. Our commitment to our team includes: • Health & Wellness:, • Medical, Dental, and Vision insurance plans with various coverage options., • Flexible Spending Accounts (FSA) and Health Savings Accounts (HSA) to help manage healthcare costs., • Wellness programs and resources., • Financial Security:, • Competitive salary and performance-based incentives., • 401(k) retirement plan with Company Match., • Life and Disability insurance., • Work-Life Balance:, • Generous Paid Time Off (PTO) policy, including vacation, sick days, and company holidays., • New Jersey State-mandated benefits: Temporary Disability Insurance (TDI) and Family Leave Insurance (FLI)., • Professional Development:, • Opportunities for continuous learning and professional growth., • Tuition reimbursement program., • Access to online training platforms and industry conferences., • Additional Perks:, • Employee assistance program (EAP)., • Onsite gym. Salary Range (annually) $85,000-$119,00.00

Job DescriptionQuality Assurance ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs. The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes. • Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Establish and maintain policy for documentation of all products and perform internal documentation audits., • Author and review relevant SOPs, validation and other documents., • Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review., • Control Master Batch Records, distribution and label verification., • Perform line clearance activities as required., • Assign and maintain product lot numbers as applicable., • Ensure materials management nonconformance disposition and release activity as applicable., • Ensure 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., • 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., • Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks., • Provide support to manufacturing for investigations of deviations, validations, and development of specifications, • Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements., • Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted., • Perform employee training on QSR and ISO requirements and company quality systems, • Perform document control activities as assigned., • Mentor/train/develop and manage Quality Assurance team., • Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality Agreements, • Travel may be requiredREQUIREMENTS, • BS Degree in biological sciences or equivalent., • Minimum 5-10 years related experience in the pharmaceutical or biologics industry., • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)., • Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc., • Sound knowledge of aseptic processing and supporting technologies., • Analytical and technical troubleshooting skills are a plus., • Proficient with Microsoft Office Suite., • Excellent organizational skills and attention to detail., • Good verbal and written communication skills., • Strong team-oriented interpersonal skills are essential., • Strong business acumen, • 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, • Meeting management/facilitation skills/teamwork, • Ability to multi-task is essential, • Flexible and able to adapt to company growth and evolving responsibilitiesPlease 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 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 Description The L2 Automation Plant Engineer (Sea Vision) is responsible for the ongoing support, maintenance, and optimization of the plant's automation and control systems, with a specific focus on the Sea Vision serialization platform and associated machine vision systems. This role ensures maximum efficiency, compliance with industry regulations (e.g., GMP, FDA), and minimal downtime in a high-volume manufacturing environment. The engineer operates as a subject matter expert for assigned automation areas and may lead small to medium-sized projects or support larger capital initiatives. Requirements System Support and Troubleshooting: Provide 24/7 technical support for L2 automation systems, performing root cause analysis and resolving hardware and software issues with minimal guidance. Sea Vision Expertise: Serve as the primary Subject Matter Expert (SME) for the Sea Vision serialization and vision inspection systems, including configuration, programming (if required by the specific system setup), and troubleshooting. Maintenance and Optimization: Develop and manage plans to maintain and improve existing process control systems and vision technologies to enhance performance, reliability, and efficiency. Project Execution: Lead or support the implementation of new automation solutions, system upgrades, and interfaces, ensuring all work is executed in coordination with production schedules and change management standards. Validation and Compliance: Assist in the preparation and execution of Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), commissioning, and validation protocols (CSV) to ensure compliance with cGMP and regulatory standards. Documentation and Training: Develop and maintain detailed documentation, including User Requirements Specifications (URS), Functional Specifications (FS), Detailed Specifications (DS), SOPs, and training materials for end-users and maintenance staff. Collaboration: Work closely with cross-functional teams, including Manufacturing, Quality Assurance, IT, and maintenance personnel, to ensure seamless integration and alignment of automation activities with business goals. Vendor Management: Manage vendor service contracts and coordinate with suppliers for technical clarifications, support, and new technology evaluation. Required Skills & Qualifications: Education: Bachelor’s degree in engineering (Electrical, Mechanical, Automation, or Computer Science) or a related technical field. Experience: 4-6 years of experience in an automation or manufacturing support role, preferably within the pharmaceutical, biotech, or similarly regulated industry. Technical Knowledge: Proficiency with industrial control systems (PLCs, SCADA, HMIs) (e.g., Allen-Bradley, Siemens). Direct experience with Sea Vision serialization software and associated machine vision hardware (cameras, lighting, optics). Strong understanding of network protocols and IT/OT integration in a plant environment. Problem-Solving: Strong problem-solving skills to identify and resolve operational and quality issues efficiently. Attention to Detail: A high level of attention to detail to ensure accuracy in serialization, documentation, and quality control. Communication: Excellent written and verbal communication skills to effectively communicate with team members and management. Compliance Knowledge: Understanding of safety regulations, GMP, and relevant industry standards (e.g., 21 CFR Part 11).

Job Description GMP Sr. Auditor Paramus, NJ If you post this job on a job board, please do not use company name or salary. Experience level: Mid-senior Experience required: 5 Years Education level: Bachelor’s degree Job function: Accounting/Auditing Industry: Pharmaceuticals Pay rate : View hourly payrate Total position: 1 Relocation assistance: No Visa sponsorship eligibility: No Job Summary: The RPT QA Auditor is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with cGMP, regulatory requirements, and company quality standards. This role supports the Pharmaceutical Quality System (PQS) by identifying gaps, recommending corrective actions, and driving continuous improvement across manufacturing, testing, and distribution processes. Key Responsibilities: Conduct routine, for-cause, and risk-based audits of internal processes, RPT CMOs, and suppliers. Prepare detailed audit plans, checklists, and schedules. Ensure adherence to FDA, EMA, ICH, and other applicable regulatory guidelines. Review and approve deviations, CAPAs, and change controls. Document audit observations and issue formal audit reports. Track and verify implementation of corrective and preventive actions (CAPAs). Provide guidance on compliance requirements and audit readiness. Support regulatory inspections and customer audits. Identify systemic issues and recommend process improvements. Stay updated on evolving regulatory requirements and industry best practices. Qualifications: Bachelor’s degree in Life Sciences, Pharmacy, or related field. 3–5 years in Radio Pharmaceuticals, with at least 2 years in auditing. Strong knowledge of RPT cGMP, GDP, and global regulatory requirements. Excellent attention to detail and analytical skills. Strong communication and report-writing abilities. Ability to travel (up to 10%) for audits. Preferred Certifications: ASQ Certified Quality Auditor (CQA) ISO 9001 Lead Auditor GCP/GMP auditing certifications

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. 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., • 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., • 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.

Company Description Stira Pharmaceuticals is a sterile injectable CDMO specializing in small molecules and peptides, with deep expertise in pharmaceutical product development and manufacturing. Our team of skilled scientists leverages proprietary technology platforms and extensive industry experience to develop innovative solutions for challenging products. We provide a comprehensive range of services, including Analytical R&D, Formulation Development, Stability Testing, Microbiology, Regulatory Support, and more. At Stira, we are committed to delivering high-quality, reliable solutions that meet the evolving needs of our global clients. Role Description This is a full-time, on-site Director of Business Development role based in Fairfield, NJ. The selected candidate will lead and expand business development initiatives for Stira Pharmaceuticals’ sterile Contract Development & Manufacturing Organization (CDMO) and Analytical Services. You will be responsible for identifying and acquiring new business opportunities, creating and executing strategic business plans, generating leads, managing key accounts, negotiating contracts, and fostering long-term client relationships. Close collaboration with internal teams to align business goals with client needs is a critical part of this role. Key Responsibilities • Develop and execute business development strategies to grow the sterile CDMO and analytical services business., • Identify, engage, and acquire new clients for development, tech transfer, analytical testing, and manufacturing programs., • Lead proposal development, pricing strategy, contract negotiation, and deal closure., • Build and maintain a strong pipeline of opportunities across peptides, long-acting injectables, ophthalmic products, small-molecule injectables, and other complex formulations., • Represent Stira at conferences, client meetings, and industry events to promote capabilities and generate leads., • Collaborate with internal cross-functional teams (R&D, Analytical, QC, Manufacturing, Regulatory) to develop tailored client solutions., • Understand client program requirements and translate them into actionable scopes of work., • Monitor industry trends, competitor activities, and market dynamics to support strategic decisions., • Maintain CRM tracking, forecasting, reporting, and KPI management to support executive leadership., • Support the creation and refinement of marketing materials, capability decks, and external communications. Qualifications • Bachelor’s or Master’s degree in Life Sciences, Chemistry, Pharmacy, or a related field; advanced degree preferred., • 10+ years of experience in business development within a sterile injectable CDMO, pharma outsourcing, or analytical services environment., • Strong knowledge of sterile manufacturing processes, analytical method development/validation, and CMC workflows., • Proven track record in securing new business, managing client accounts, and achieving revenue targets., • Excellent communication, negotiation, and relationship-building skills., • Ability to work independently in a fast-paced, growing organization., • Willingness to travel for client visits and industry events. How to Apply Interested candidates may submit their resume and a brief cover letter via LinkedIn or email • with the subject line: Director, Business Development Application.

Job DescriptionRole Summary Lexeo Therapeutics is seeking a highly motivated and experienced CMC Project and Operations Contractor to join our Technical Operations team. This role will support the Chemistry, Manufacturing, and Controls (CMC) functions by organizing activities, driving strategic initiatives and facilitating operational excellence in support ofLexeo’sgene therapy portfolio. The contractor will collaborate within CMC functions to ensure successful execution and timely completion of CMC deliverables, compliance with regulatory requirements, and alignment with organizational goals. Primary Responsibilities • CMC Strategic Planning: Develop and implement CMC strategies to support preclinical product development, clinical trial material manufacture and supply, late-stage development, validation, BLA preparation, launch activities and commercialization. For both pre-clinical and clinical stage projects provide expert guidance on CMC program timelines, risk management, and resource allocation. Harness the strengths of functional areas, establish a cohesive integrated development strategy, set clear team goals, • Project Management: Lead and manage CMC workstreams, including tracking of milestones, coordinating cross-functional teams, and ensuring timely completion of deliverables. Preparation and execution of comprehensive Project and Development plans and associated documents for each project ensuring the requirements for all relevant areas are achieved. Lead project team meetings. Maintain CMC RAID, “Risks, Actions, Issues, and Decisions” log, project plans and dashboards., • Operational Excellence: Optimize CMC processes and workflows to improve efficiency, quality, and compliance. Identify and address operational bottlenecks, implement best practices, and facilitate continuous improvement initiatives., • Regulatory Support: Collaborate with Regulatory Affairs to prepare CMC sections of regulatory filings (INDs, CTAs, BLAs). Ensure documentation meets global regulatory standards and supports successful submissions., • Vendor and Partner Management: Support relationships with CDMOs, contract testing laboratories and other external partners. Ensure clear communication of requirements, monitor performance, and facilitate resolution of issues. Incorporate third party timelines into Lexeo Tech Ops integrated project plans, • Budget and Resource Coordination: Support budgeting, forecasting, and resource planning for CMC activities. Track expenditures and provide status updates to Technical Operations leadership., • Reporting and Communication: Prepare and present project updates, dashboards, and reports for internal and external stakeholders. Support the communication of CMC strategy and progress effectively across teams. Required Skills & Qualifications, • Bachelor’s degree in chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related field; advanced degree preferred., • Minimum of 8 years’ experience in CMC operations, strategy, or project management within the biotechnology or pharmaceutical industry., • Proven track record in managing CMC initiatives for clinical-stage or commercial products., • Strong understanding of gene therapy, biologics, or advanced therapies manufacturing and regulatory requirements., • Exceptional organizational, communication, and analytical skills., • Excellent leadership, emotional intelligence, and communication skills, • Ability to work independently and in a fast-paced, dynamic environment.

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: Staff Accountant that will play a key role in supporting the month end close process, maintaining accurate financial records Minimum Qualifications: • Bachelor’s degree in Accounting, Finance, or a related field., • CPA or progress toward CPA is a plus, • 2–5 years of accounting experience, preferably in a publicly traded pharmaceutical, biotech, or life sciences industry., • Strong understanding of US GAAP and internal control principles., • Advanced Excel skills (VLOOKUP, pivot tables, formulas)., • Experience with inventory accounting and cost of goods sold (COGS) is a plus., • Excellent analytical, organizational, and communication skills., • Ability to work independently in a fast-paced, evolving environment. Responsibilities: • Prepare and post journal entries in NetSuite related to prepaids, revenue, expenses, accruals, and general ledger accounts., • Reconcile balance sheet accounts, including cash, inventory, prepaid expenses, and accrued liabilities., • Assist in monthly, quarterly, and year-end close processes in compliance with GAAP and internal deadlines., • Support the accounting and finance team with audits, including preparation of schedules and documentation., • Collaborate with cross-functional teams, including R&D, manufacturing, and supply chain, to ensure accurate financial tracking of pharmaceutical operations., • Maintain fixed asset schedules and perform depreciation calculations., • Monitor and record intercompany transactions and reconcile intercompany balances., • Assist with the preparation of financial statements and management reports., • Ensure compliance with internal controls and help identify opportunities for process improvement. Recruitment & Staffing Agencies 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 $60,000 to $90,000 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 Description SUMMARY: • Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities., • Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions., • Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions, • Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions, • Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines., • Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions., • Assess and communicate potential regulatory risks and propose mitigation strategies, • Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications., • Identify, communicate and escalate potential CMC regulatory issues, as needed, • Help establish regulatory CMC submission processes and procedures., • Familiar with eCTD format submission files, • Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format., • Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals., • Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory authority questions., • Ensure compliance with FDA, EMA, and ICH guidelines and internal processes., • Collaborate with cross-functional teams to gather accurate technical information., • Identify and communicate potential regulatory risks; propose mitigation strategies., • Education: Bachelors or advanced degree in Chemistry, Pharmaceutical Sciences, or related field., • Experience: Minimum 5 years in pharmaceutical regulatory writing or CMC project management., • Strong knowledge of manufacturing processes, analytical methods, specifications, and validation activities., • Familiarity with global regulatory frameworks and eCTD submissions., • Excellent technical writing, communication, and organizational skills., • Proficiency in Microsoft Office Suite (Word, Excel, Outlook 365, PowerPoint)., • Experience with any of IND/NDA/BLA submissions and EU MAA/IMPD filings., • Ability to interpret and apply regulatory guidelines effectively., • Strong project management and stakeholder communication skills.

Job Description Our client is seeking a CMC Writer to join their team. & SUMMARY: • Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities. JOB DESCRIPTION: • Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions., • Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions, • Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions, • Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines., • Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions., • Assess and communicate potential regulatory risks and propose mitigation strategies, • Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications., • Identify, communicate and escalate potential CMC regulatory issues, as needed, • Help establish regulatory CMC submission processes and procedures., • Familiar with eCTD format submission files KEY RESPONSIBILITIES: • Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format., • Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals., • Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory authority questions., • Ensure compliance with FDA, EMA, and ICH guidelines and internal processes., • Collaborate with cross-functional teams to gather accurate technical information., • Identify and communicate potential regulatory risks; propose mitigation strategies. QUALIFICATIONS: • Education: Bachelor’s or advanced degree in Chemistry, Pharmaceutical Sciences, or related field., • Experience: Minimum 5 years in pharmaceutical regulatory writing or CMC project management., • Strong knowledge of manufacturing processes, analytical methods, specifications, and validation activities., • Familiarity with global regulatory frameworks and eCTD submissions., • Excellent technical writing, communication, and organizational skills., • Proficiency in Microsoft Office Suite (Word, Excel, Outlook 365, PowerPoint). PREFERRED SKILLS: • Experience with any of IND/NDA/BLA submissions and EU MAA/IMPD filings., • Ability to interpret and apply regulatory guidelines effectively., • Strong project management and stakeholder communication skills.

Responsibilities • Drive HR strategy by partnering with leadership on talent planning, recruitment, retention, and succession initiatives, • Provide expert guidance on complex HR issues, including accommodations, investigations, disciplinary actions, and terminations, • Manage HR systems and processes such as timekeeping, benefits enrollment, time‑off requests, and employee record accuracy, • Develop and evaluate programs by analyzing compensation trends, proposing competitive pay structures, and creating learning and development opportunities, • Ensure compliance and best practices through policy reviews, regulatory adherence, and staying current on HR trends and employment law Qualifications • Bachelor’s degree in Human Resources, Business Administration, or a related discipline; Master’s degree preferred, • At least three years of HR management experience, with leadership background strongly desired, • SHRM-CP or SHRM-SCP certification Salary: $100k-$140k Ask for: Aarti Manchanda Ajulia Executive Search is a New Jersey based Executive Search Firm specializing in retained searches in multiple sectors, including Manufacturing, Finance, IT, Legal, and Pharmaceutical. We have a nationwide client base and offer services in temporary and direct hire placements

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

Job DescriptionJob Title: Gross to Net Sr. Accountant Job Description A leading manufacturer of generic drugs is seeking a Sr. Accountant with expertise in Gross to Net accounting. This role is essential for managing and overseeing the financial operations related to cost accounting, revenue side activities, and variance analysis. Responsibilities • Perform cost accounting activities including cost of goods sold (COGS), raw materials, and labor costs., • Manage intercompany transactions and consolidations., • Execute journal entries and conduct variance analysis., • Handle Gross to Net related activities including cash receipts, accruals, Medicare rebates, and manage credit memos and debit notes from chargebacks and deductions., • Prepare monthly financial statements and reports., • Proficiency in cost accounting and understanding of COGS., • Experience with intercompany transactions and consolidations., • Strong skills in variance analysis., • Knowledge of Gross to Net processes, including deductions and chargebacks., • Bachelor's Degree in Accounting, Finance, or Business is preferred. Join a dynamic accounting team of six, including a CFO, a General Manager, a Sr. Accountant, a Contracts Analyst, and two Jr. Accountants. The work environment is business casual. The standard work hours are Monday through Friday, 9 AM to 5:30 PM, with extended hours during month-end to ensure a tight 4-day close. Reports must be submitted to the Global Headquarters by the 6th of each month. Job Type & Location This is a Contract position based out of Queens Village, New York. Job Type & Location This is a Contract position based out of Jamaica, NY. Pay and Benefits The pay range for this position is $45.00 - $55.00/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 Jamaica,NY. Application Deadline This position is anticipated to close on Dec 15, 2025. About Aston Carter: Aston Carter provides world-class corporate talent solutions to thousands of clients across the globe. Specialized in accounting, finance, human resources, talent acquisition, procurement, supply chain and select administrative professions, we extend the capabilities of industry-leading companies. We draw on our deep recruiting expertise and expansive network to meet the evolving needs of our clients and talent community with agility and excellence. With offices across the U.S., Canada, Asia Pacific and Europe, Aston Carter serves many of the Fortune 500. We are proud to be a ClearlyRated Best of Staffing® double diamond winner for both client and talent service. 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 process due to a disability, please email for other accommodation options.

Job Description Job description Granulation Technology, Inc. is a leading pharmaceutical manufacturer specializing in high-quality OTC (over-the-counter) products. As a fast-growing, Indian-owned and majority women-owned company, we are committed to excellence, innovation, and customer satisfaction. Role Overview: We are seeking a results-driven Pharmaceutical OTC Sales Representative to expand our market presence, secure new accounts, and maintain strong relationships with key customers. This is an exciting opportunity for a sales professional with experience in the pharmaceutical OTC industry. Responsibilities: ✅ Identify and develop new sales opportunities within the OTC pharmaceutical market. ✅ Build and maintain relationships with distributors, retailers, and healthcare providers. ✅ Present and promote our OTC products to potential clients. ✅ Negotiate contracts, pricing, and supply agreements. ✅ Stay updated on industry trends, competitor activity, and market demands. ✅ Collaborate with internal teams (marketing, regulatory, and logistics) to ensure customer satisfaction. ✅ Meet or exceed sales targets and KPIs. Qualifications: Experience: 10+ years in OTC pharmaceutical sales. Skills: Strong negotiation, relationship-building, and communication skills. Knowledge: Familiarity with the OTC market, retail distribution, and pharmacy channels. Self-Motivated: Ability to work independently and drive results. Travel: Willingness to travel as needed for client meetings and industry events. Why Join Us? ✨ Opportunity to work with a growing pharmaceutical company. ✨ Competitive salary with uncapped commission potential. ✨ Flexible work environment with career growth opportunities. ✨ Be part of a dynamic, diverse, and innovative team. Company DescriptionGranulation Technology Inc is in the business of chemical and pharmaceutical manufacturing and distribution company that has been in business since 1997 successfully serving small to Fortune 500 companies. GTI is an FDA GDUFA listed facility. It is a fully functional 35,000 sq. ft. cGMP facility. DEA registered to handle Class II – V controlled substances. We have been consistently adding to our large list of clienteles ensuring their high demands for quality & safety standards in their products are met. At Granulation Technology, Inc. we strive to provide the highest quality products that comply with FDA regulations, meet USP and are manufactured under GMP and ISO standards. This approach ensures high quality products while providing cost competitive advantages.Granulation Technology Inc is in the business of chemical and pharmaceutical manufacturing and distribution company that has been in business since 1997 successfully serving small to Fortune 500 companies. GTI is an FDA GDUFA listed facility. It is a fully functional 35,000 sq. ft. cGMP facility. DEA registered to handle Class II – V controlled substances. We have been consistently adding to our large list of clienteles ensuring their high demands for quality & safety standards in their products are met. At Granulation Technology, Inc. we strive to provide the highest quality products that comply with FDA regulations, meet USP and are manufactured under GMP and ISO standards. This approach ensures high quality products while providing cost competitive advantages.

Job DescriptionCompany Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description High Throughput Process Development Scientist responsibilities include, but are not limited to, the following: • Execute high throughput process development (HTPD) experiments with BSL-1 and BSL-2 biological agents and viruses., • Operate and maintain laboratory automation equipment (Tecan, Hamilton) to support HTPD screening experiments., • Perform analytical testing, including cell-based assays, biochemical testing, and/or HPLC to support HTPD experiments, and participate in development of new assays as needed., • Prepare laboratory reagents, solutions and culture media, • Analyze, collate, track, and report data back to client staff members, • Maintain records and test results following good manufacturing practices (GMP), • Work independently and efficiently, • Document work clearly and perform tests accurately, • Communicate effectively with client staff membersQualifications Minimum Qualifications: • B.S. in Biology, Cell Biology, Bio/chemical Engineering, or related science, • One year of general lab experience working with automated handlers like TECAN and Hamilton to support assays, • General laboratory skills, with at least one year of laboratory experience, • At least six months experience with aseptic and cell culture techniques, • Experience with cell-based (imaging, flow cytometry) and biochemical analytical techniques, • Highly computer literate. Capable of quickly learning and adapting to new computer programs. Experience using formulas and linking spreadsheets in Excel., • Experience in programming/coding (e.g. equipment software, Visual Basic, C++, MatLab, or Python programming) is considered a plus., • Experience working with laboratory automation or advanced computer-controlled laboratory equipment, such as chromatography workstations (e.g. Akta), or robotic liquid-handlers (e.g. Tecan or Hamilton)., • Strong computer, scientific, and organizational skills, • Excellent communication (oral and written) and attention to detail, • Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude, • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies Additional Information This position is Full-Time, Monday through Friday, 9a.m. to 5 p.m with overtime as needed. Candidates currently living within a commutable distance of Rahway, NJ are encouraged to apply. The compensation range for this role is between $24-25/hr based on experience. • Excellent full time benefits including comprehensive medical coverage, dental, and vision options, • Life and disability insurance, • 401(k) with company match

Job Description Job Title: Quality Assurance Specialist III Job Description The Quality Assurance Specialist II is responsible for managing change controls and coordinating with cross-functional departments to ensure compliance with regulatory requirements. This role involves maintaining programs to ensure high-quality products and compliance with Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs). The specialist will independently conduct, complete, and document deviation investigations related to GxP operations and perform reviews of Executed Batch Records for Biologics Drug Substance (DS) and Drug Product (DP). Responsibilities • Manage change controls and complexities for Contract Manufacturing Organizations (CMOs)., • Perform activities to ensure compliance with regulatory requirements., • Maintain programs and processes for high-quality products and compliance with cGMPs and GLPs., • Conduct and document major and minor deviation investigations., • Review Executed Batch Records for Biologics DS and DP., • Participate in cross-functional meetings with internal and external parties., • Apply Root Cause Analysis tools to identify causes and propose corrective actions., • Support management and tracking of quality system records for adherence to targets., • Maintain tracking tools/databases and send periodic reminder notifications., • Support management review process with quality system metrics and issue escalation., • Assist in compliance audits and write/implement changes to controlled documents., • Proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs)., • Strong application of QA principles, concepts, industry practices, and standards., • Knowledge of FDA/EMEA standards and quality systems., • Experience with Six Sigma, LEAN, and root cause analysis tools., • Strong investigation and report writing skills., • Excellent verbal, technical writing, and interpersonal skills., • 5+ years of relevant experience in a GMP environment with a BS or BA., • 3+ years of relevant experience with a MS degree., • Experience in the pharmaceutical industry, particularly with QA reviews of Executed Batch Records. This position offers a hybrid work model, with work-from-office on Wednesdays and Thursdays, and work-from-home on Mondays and Fridays. Enjoy a long-term opportunity with benefits including two weeks of paid time off and nine paid holidays. Job Type & Location This is a Contract position based out of Parsippany-Troy Hills, NJ. Pay and Benefits The pay range for this position is $45.00 - $55.00/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 hybrid position in Parsippany-Troy Hills,NJ. Application Deadline This position is anticipated to close on Dec 17, 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 Job Title: Aseptic Technician Job Description We are looking for an Aseptic Technician to assist with the validation of new areas, including manufacturing equipment and processes. You will collaborate with cross-functional teams such as Quality Assurance, Quality Control, and Maintenance to troubleshoot issues and resolve deviations. Your role will involve participating in aseptic process simulations, media fills, and equipment qualifications, as well as conducting in-process inspections and quality control checks to ensure product quality. You will also be responsible for completing necessary documentation, adhering to cGMP and Good Documentation Practices, and contributing to continuous improvement initiatives. Responsibilities • Assist with initial and subsequent validation of new manufacturing equipment and processes., • Collaborate with cross-functional teams to troubleshoot issues and resolve deviations., • Participate in aseptic process simulations, media fills, and equipment qualifications., • Conduct in-process inspections and quality control checks to verify product integrity., • Complete logbook, form, and batch record documentation as required., • Contribute to continuous improvement initiatives., • Maintain qualification to work within Grade A and Grade B cleaning environments., • Comply with policies, guidelines, and regulatory requirements of the Quality System and applicable cGMPs., • Experience in cleanroom and aseptic environments., • Knowledge of aseptic techniques, cGMP, and cleanroom protocols., • Ability to read and comprehend work instructions and standard operating procedures., • Understanding of equipment alarms and escalation procedures., • Exceptional attention to detail, accuracy, and documentation skills., • High school diploma or equivalent; additional technical or vocational education is a plus., • Minimum 1 year of experience in the pharmaceutical/biopharma/biotech industry within aseptic cleanroom environments. You will work in a controlled Grade A and B cleanroom environment where aseptic gowning is crucial. This position requires flexibility to work during various shifts, including evenings, nights, weekends, and holidays, as needed by production schedules. Job Type & Location This is a Contract to Hire position based out of Parsippany, NJ. Pay and Benefits The pay range for this position is $28.00 - $28.00/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 Parsippany,NJ. Application Deadline This position is anticipated to close on Dec 17, 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 About Lantheus Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. Today, we’re expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world. At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We’re dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress. Join us and be part of a company where your contributions make a real impact, because we know someone’s health is in our hands. This role will be based at Evergreen Theragnostic, a Lantheus company, located in New Jersey. Summary of role We are seeking an Associate Director, Quality Control. The Associate Director, QC, acts as senior leadership for the Quality Control operation at Lantheus’ Evergreen site. This position will oversee and lead the QC department at Evergreen. This role will be accountable for governing the department in terms of function and responsibility as well as providing technical guidance/decisions (when needed) for the operational levels to ensure an efficient and structured operation that can cater to internal as well as external needs within the organization to deliver quality radiopharmaceutical products. This role will be the primary accountable person for the success of the QC department operations at Evergreen Theragnostics in terms of efficiency, skill retention and compliance. Ensures processes are designed and compliant per applicable cGMPs, 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 accountable for the review and authoring of key CMC submissions, along with setting relevant standards for analytical operations. This position is based in New Jersey and requires a presence on-site, three days per week, and open to applicants authorized to work for any employer within the United States. Responsibilities • Design, establish and maintain a standard QC operational structure with assigned roles and responsibilities that can be aligned with the needs of the organization., • Oversee the creation and maintenance of a QC training matrix and program to ensure consistency in execution and retention of capability & skill., • Define specific qualification standards for SMEs and the subsequent qualification processes., • Manage mid-management (supervisors, managers etc) direction to ensure alignment of objectives and completion of deliverables by the department., • Provide technical guidance and decisions to mid-management in order to be able to achieve the required objectives and deliverables., • Design, maintain and defend the internal departmental processes to ensure compliance to cGXP requirements., • Oversee and manage departmental efficiency and proficiency to enable a lean operation., • Review and approve department related protocols, procedures, test methods, and studies as appropriate. Responsible to create, maintain and harmonize key business processes with internal and external stakeholders., • Partner 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., • Partner with Business Development (BD) team in identifying and evaluating new technological platforms and pipeline products for Lantheus’ business growth., • Partner with site operations to effectively deliver analytical services to meet product release timelines for future product supply. Partner with existing sites in the network to incorporate lessons learned from ‘sending’ sites for an optimized analytical process., • Leads, motivate, mentor, and develops team members to exceed and meet company goals., • Develop and maintain effective working relationships with other division groups and external partners in support of technology transfer, validation, and process support activities., • Lead assigned operational personnel in owning Quality processes within the required responsibility of the department (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., • Actively promotes safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment., • Report and take initiative to correct safety and environmental hazards., • Actively demonstrate Lantheus’ values Basic Qualifications • Requirements include a B.S. in relevant scientific/technical disciplines, advanced degrees (e.g., MS) or technological certificates preferred but not required., • 2+ years of experience in the radiopharmaceutical industry preferred but not required, • Minimum 10+ years experience in a GMP Quality Control Environment., • Minimum 5+ years experience in people management and conflict resolution., • Minimum 3+ years experience in defending QC operations against FDA and EMEA regulatory inspections., • Previous experience with managing a microbiology department is preferred., • Subject matter expert (SME) in various analytical test methods and analytical technology. Strong knowledge of global regulatory requirements related to the design and control of these processes., • Knowledge of SOPs, cGMPs, GCPs 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 analytical processes., • Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing & testing., • Excellent organizational skills and the ability to successfully manage a multitude of technical projects., • Ability to work in a fast paced, 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 EMEA 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 Lantheus and the Evergreen site to external organizations and must exhibit the highest levels of personal integrity, quality, and professionalism. The ideal candidate will embody Lantheus core values: • Let people be their best, • Respect one another and act as one, • Learn, adapt, and win, • Know someone’s health is in our hands Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until January 12, 2026. Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law. Lantheus is an E-Verify Employer. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at .

Job DescriptionCompany Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies. Job Description The Sales Account Executive is a client facing outside sales role operating within an assigned region of New York and New England. This involves identifying and managing client accounts and business opportunities for Eurofins Built Environment Testing Division. Built Environment is a group of laboratories that provides Indoor Air Quality (IAQ) testing for things such as mold, asbestos, Legionella, etc. The Account Executive will travel throughout the region to meet with clients. This individual must be comfortable with cold calling and taking initiative to bring in new business as well as cultivate existing relationships. Knowledge and understanding of environmental laboratory testing is ideal, specifically in indoor air quality testing, USP797 testing or Legionella testing. As part of the sales team, you will focus on: • Maximizing market share, profitability, competitive advantage and capacity utilization in the environmental analytical services market., • Establish and maintain productive relationships with Eurofins clients., • Provide vision and acquire new accounts to sustain growth of the business by representing Eurofins, clearly communicating Eurofins services to new customers and markets., • Identify opportunities and profitable work by following up on leads, negotiating, and closing., • Responsible for meeting individual revenue as well as the goal for assigned region., • Establishes and maintains a productive working relationship between the client and laboratory., • Ensures customer awareness of Eurofins Environment Testing capabilities and services to improve selling opportunities., • Provides sales plan forecast for assigned region., • Reviews credit status of both new and existing customers prior to submitting bids or proposals for new work., • Monitors accounts receivable status for accounts assigned and resolves collection issues as required., • Develops and recommends strategies to facilitate pricing and bid/no bid decisions, establish Master Service agreements and provide budgetary information., • Develops client profiles and determines potential and ability to fund work., • Develops, qualifies, tracks, and closes leads to increase revenue., • Reports sales activity within assigned area., • Updates customer databases to identify business opportunities., • Maintains productive relationships between customers and the Eurofins Environment Testing organization., • Develops and implements account plans detailing specific clients, revenue goals and related account objectives to attain regional revenue quotas., • Identifies key target markets and major accounts and develops strategies within assigned area of responsibility to attain market position for Eurofins Environment Testing and maintain profitability., • Establishes, coordinates, negotiates, and completes Master Service, • Agreements with customers which both defines customers’ specific needs and streamline processes., • Within area of market responsibility collects and documents information to establish pricing and evaluate Eurofins Environment Testing’s ability to meet customer requirements to meet win/loss ratios, average discount percentages and profitability., • Effectively communicates customer needs and wants to Eurofins Environment Testing, • Customer Service Managers and Project Managers to facilitate successful completion of work., • Completes summaries of sales development activities as directed by GM., • Communicates all business opportunities (e.g. bids, quotes, proposals, and pricing inquires) by providing copies or entering information into Eurofins Environment Testing’s database., • Follows up on all outstanding bids, quotes, proposals, and price inquiries in order to achieve successful completion of the sales cycle., • Negotiates pricing and contractual issues within area of responsibility with the approval of the GM., • Presents Environment Testing as a network of laboratories not limited to lab facilities within a geographical region to improve operational efficiencies., • Controls expenses with respect to the selling function pursuant to Eurofins Environment Testing’s policy and with approval by GM., • Assumes role as “sponsor” for National Accounts as needed., • Provides feedback on market conditions within area of responsibility to facilitate the development of new products and services., • Maintains relationship with one or more of Eurofins Environment Testing’s network facilities to sustain awareness of operational issues related to Eurofins Environment Testing’s ability to meet customer requirements., • Provides information concerning business opportunity outcomes with respect to win/lose ratios and future pricing strategies., • Provides forecasting information to Customer Service Managers to assist operational staff with resource and operational planning., • Assists with the development of sales materials., • Gathers and communicates intelligence information on competitors within area of responsibility., • Identifies and communicates opportunities for new products and services within assigned region.Qualifications Basic Minimum Qualifications: • Degree in Sciences or related field preferred but not required, • Minimum 2-3 years progressively successful sales experience in a service industry, • Ability and willingness to travel throughout the assigned territory. Some overnight travel may be required., • Environmental industry knowledge., • Sales specific skills of identification of prospects, interviewing, negotiating, and closing, • Strong interpersonal skills, • Excellent written and verbal communication skills, • Sales acumen/sales skills, • Lab experience and exposure to environmental industry preferred., • Writing sales and account plans, • Working computer skills, • Familiarity with lab functions and terminology, • Analytical skills, • Planning skills, • Self-directed, • Ability to work in an unstructured environment Additional Information Requirements: • Authorization to work in the United States indefinitely without restriction or sponsorship Salary Range: minimum of $70,000/yr base + Commission with benefits, PTO and company matching 401K plan. **Salary range could be higher for candidates with specific sales experience in environmental testing, especially Indoor Air Quality (IAQ) testing. Eurofins Environment Testing (USA) provides a compensation range for informational purposes, the actual base salary may vary based upon, but not limited to, relevant experience and skill set, base salary of internal peers, business sector, and geographic location. As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. we offer excellent benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays, paid time off, and dental and vision options. *The benefits package offered will vary based on the employee's full-time or part-time regular status. To learn more about Eurofins, please explore our website . We support your development! Do you feel you don’t match 100% of the requirements? Don’t hesitate to apply anyway! Eurofins companies are committed to supporting your career development. We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique. Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal! Find out more in our career page: Company description: Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in discovery pharmacology, forensics, advanced material sciences and Eurofins Scientific 2/2 March 2023 agroscience contract research services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2022, Eurofins generated total revenues of EUR 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years. Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.

Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant with our direct client, a global pharmaceutical consumer goods manufacturing client in Summit, NJ. No Third-Party, No Corp to Corp, No Sponsorship Title: ServiceNow (CSM) Business Analyst Location: Summit, NJ Remote (Mon-Fri, 40 hours) must be able to work in LATAM, ANZ, APAC time zones Contract Duration: 12 months, with likely extension Pay Rate: $42.00 per hour (w2) • Must Have Service Now CSM Customer Service Module experience only!, • Must Be Able to work in various times zones supporting LATAM, ANZ and APAC., • Must Have Exceptional English Speaking Communication Skills ServiceNow Business Analyst Customer Service Module (CSM) We are seeking a ServiceNow Business Analyst for a multi-million-dollar initiative to implement ServiceNow’s Customer Service Management (CSM) solution for our Call Center operations in LATAM, specifically Colombia. This role will involve collaboration with teams globally, including regions such as India, LATAM, ANZ, APAC, and potentially EMEA. Key Responsibilities: • Act as the primary Business Analyst for the implementation of ServiceNow’s Customer Service Management (CSM) module., • Collaborate effectively with system integrators (e.g., SAP, Twilio/WhatsApp/WebMethods MFT), client technical teams, business stakeholders, and the Project Manager to ensure smooth project execution., • Lead weekly project plan calls, ensuring the team remains on track and documenting meeting notes and action items., • Capture and document user stories and requirements using Agile methodologies (e.g., JIRA, Scrum, Confluence)., • Manage testing processes and ensure business engagement and participation in User Acceptance Testing (UAT)., • Develop new enhancements for the CSM module, leveraging experience with various instances of ServiceNow., • Lead architectural reviews for necessary review boards to ensure that solutions align with technical standards and business needs., • Identify and articulate project risks and concerns, knowing when to escalate issues to appropriate stakeholders., • Maintain a high-level understanding of system integrations and IT architecture models to inform project decisions., • Document weekly status reports and communications using Microsoft PowerPoint and Excel., • Liaise with Business Analysts to review platform enhancement opportunities and identify value-added initiatives. Qualifications: • 5-8 years of solid experience in business analysis, preferably within Supply Chain IT and ServiceNow CSM., • Proven ability to perform business analysis duties for ServiceNow implementations, particularly with the CSM module., • Experience with ServiceNow is mandatory; familiarity with ServiceNow Contact Center solutions is a plus., • Experience working on complex IT-led projects across multiple workstreams., • Strong collaboration and communication skills, with the ability to work effectively with diverse teams across different geographical locations., • English is a must, • Flexibility to work across various time zones to align with global project teams., • Proven experience leading architectural reviews and engaging with relevant review boards. Additional Information: • Collaborate closely with the manager to lead a capacity team based in India, primarily working on EST time to deliver continuous improvement initiatives.

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 DescriptionSummary: The Account Manager will work as a field representative of Apotheco Pharmacies to ensure a positive customer experience and improve utilization where applicable. Account Manager will be solely responsible for customer relations within the designated Central NJ territory . Account Manager will work with District Manager and necessary Pharmacists on business plans for maintaining and developing current customer base. Account Manager will manage time in field and administratively to meet requirements of account maintenance and development. Education/Experience/Training: • Strong Communication skills, • Ability to effectively develop and build relationships with customers/individuals at all levels of an organization., • Proficient in Word, Excel, and ability to learn necessary programs for sales tools., • 2-5 Years of relevant field sales experience Account Management: • Plan, strategize and execute necessary territory objectives to meet all sales goals as set by the managements team., • Understand pharmacy programs, operations, and necessary offers to effectively communicate pharmacy benefits and services., • Quickly learn and understand new initiatives, programs and / or pricing changes., • Ensure all field materials are current week to week., • Identify marketing needs and proactively bring to management., • Lead and execute development of project goals and timelines for accounts., • Assist with executing new programs/initiatives at all pharmacies/accounts., • Operate as the lead point of contact for accounts within specified geography for all matters related to pharmacy utilization., • Build daily and weekly schedules to meet with accounts., • Understand the unique features of each account/practice., • Acts as a consultative business partner, continually identifying opportunities to improve the customer’s business through increased utilization of service/programs/solutions., • Takes lead on operational management of onboarding new accounts., • Clearly communicate the services our pharmacy locations can offer patients/accounts and uncover how our services match account needs., • Develop plans alongside account decision makers/ providers for improved utilization., • Collaborate with providers and staff to improve pharmacy communication., • Build out customer profiles for pharmacists and pharmacy technicians., • Along with Pharmacist, identify areas of improvement within accounts., • Collaborate with pharmacists at each location to create short- and long-term plans. Identify accounts for maintenance, growth, and new business on a quarterly basis., • Collaborate and communicate with Pharmacist/Pharmacy techs as needed., • Facilitate account education events as needed., • Effectively collaborate with industry colleagues including pharmaceutical & manufacturing partners., • Account Manager will have regular meetings with Business Development Manager and Pharmacist to review accounts, present on current account standings and possible business strategies., • Coordinates closely with Pharmacists for unified communication to accounts. Math Ability: Ability to comprehend and apply principles of basic math while analyzing data and generating reports. Reasoning Ability: Ability to apply principles of logical thinking to a wide range of intellectual and practical problems. Computer Skills: To perform this job successfully, an individual should have some previous experience with software products, preferably purchasing software, in addition to working knowledge of Microsoft products, especially Excel and Word. Information Security Expectations: While performing the duties of this job, the employee is required to abide by Apotheco information security policies, employee handbook and security and privacy regulatory requirements. Each employee is responsible for the secure and appropriate handling of Apotheco information, information received by customers, other companies and/or external parties. Knowledge, Skills, and Other Abilities: • Time management, • Oral and written communication skills, • Professionalism, • Organization skills, • Customer Service, • Prioritizing skills, • Detail oriented, • Multi-task abilities, • Goal oriented, • Dependable, • Confidentiality, • Self-motivated, • Ability to work well with various personalities and within a team., • Participate in continuous quality improvement activities Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to walk; sit and use hands. The employee is occasionally required to stand.

Job Description We’re seeking a Warehouse Group Leader to oversee inventory handling, personnel coordination, and day-to-day warehouse operations within a food-grade manufacturing environment. This role requires strong leadership, attention to detail, and the ability to manage product flow, documentation accuracy, and compliance with all food safety, GMP, and company standards. You’ll lead a shift of warehouse personnel, ensure accurate receiving and inventory control, coordinate outbound shipments, and support safe, efficient warehouse operations. Compensation • $22 hr, • Shift Leadership & Team Coordination – Assign tasks, supervise warehouse personnel, provide training, and ensure smooth shift operations. Step into full departmental responsibility when the Warehouse Manager is absent., • Receiving & Inventory Management – Receive finished goods, verify materials against invoices, maintain accurate inventory counts for raw, packaging, and finished goods, and ensure all items are properly tagged, labeled, and stored., • Shipping & Material Handling – Oversee loading and unloading of freight, ensure FIFO is followed for incoming and outgoing products, coordinate transportation schedules, and validate outbound accuracy., • Compliance, Documentation & SAP Use – Maintain complete and accurate paperwork for all inbound/outbound transactions; operate SAP warehouse applications and handheld scanners for receiving, posting, and tracking materials., • Quality, GMP & Food Safety Standards – Ensure all warehouse activities follow GMP, food-safety, and safety guidelines. Maintain a clean work area, ensure tools/equipment function properly, and immediately report discrepancies or damages., • Forklift Operation & Safety – Complete forklift and trailer inspections, maintain a zero-damage standard, and uphold a clean safety record in accordance with company policies., • Supplier & Customer Coordination – Communicate with suppliers regarding delivery schedules, prepare product samples as needed, and assist in reviewing open sales orders to ensure adequate inventory allocation Qualifications • Experience – Minimum 2 years of warehouse experience in a manufacturing environment, ideally within food, pharmaceutical, or nutraceutical industries., • Leadership & Teamwork – Demonstrated ability to lead a shift, train staff, delegate tasks, and maintain smooth warehouse operations., • Technical Skills – Experience with handheld scanners; ability to use SAP or similar warehouse management systems; strong understanding of inventory practices and FIFO., • Forklift Certification – Valid forklift license/certification with a strong safety record., • Documentation & Compliance – Ability to complete and manage paperwork accurately while following SOPs, GMPs, and food-safety guidelines., • Communication – Ability to read, write, and speak English effectively; strong coordination and reporting skills., • $22 hr, • Medical, dental, vision

Title: Processing Engineering Manager (Small Molecules + API) Location: New York Industry: Pharmaceutical CDMO About the Role CSG are partnered with a rapidly growing global CDMO specialising in small-molecule development, API manufacturing, and pharmaceutical intermediates. The organisation operates multiple international facilities and supports leading pharma and biotech companies through the full development and commercial lifecycle. As the business continues to expand its technical capabilities, they are seeking an experienced Process Engineering Manager to lead process development, scale-up, and manufacturing support activities within their small-molecule and API operations. This role is well-suited for a hands-on technical leader who thrives in a dynamic environment and is passionate about driving process excellence, operational reliability, and continuous improvement. Position Summary The Process Engineering Manager will oversee a team responsible for developing, optimizing, and transferring chemical processes from laboratory or pilot scale into full commercial manufacturing. You will serve as the technical authority for process engineering activities, partnering closely with R&D, Manufacturing, Quality, EH&S, and Project Management to ensure robust, compliant, and efficient production of APIs and intermediates. This is a strategic, high-visibility role with direct influence on plant performance, operational safety, process robustness, and customer satisfaction. Qualifications: • Bachelor's degree in Chemical Engineering, • Master's degree or PhD in Chemical Engineering or related discipline, • Additional training in process safety, cGMP, Six Sigma, or project management is a plus, • 8-12+ years of experience in small-molecule/API process engineering or chemical manufacturing, • Demonstrated success in process development, scale-up, and tech transfer, • Experience in a GMP-regulated CDMO, pharmaceutical, or fine chemical environment