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Job DescriptionWe are looking for an experienced Account Director to work with our clients to deliver the P10 experience. As a part of the team, you will play a pivotal role in building and maintaining strong client relationships, driving client success and account growth, and ensuring the successful execution of marketing campaigns and tactical pull through. You will be the conduit between our clients and the delivery team, collaborating closely with project management and your core internal team to ensure project delivery and client satisfaction. You have a deep understanding of pharmaceutical marketing, exceptional organizational skills, and a relentless commitment to client satisfaction. You will report to the Senior Director, Client Services. This role is open to fully remote candidates in PA, NJ, or NY due to client travel requirements. Responsibilities: • Client Relationship Management:, • Build and cultivate strong, long-lasting client relationships., • Serve as the primary point of contact for clients, understanding their needs, objectives, and ever-changing challenges., • Proactively work to identify areas of opportunity to add value to your accounts. Strategic Account Management:, • Understand the client’s business, disease area(s), and brand/product strategy., • Work collaboratively with clients and the P10 internal team to develop and execute unique and powerful strategic marketing plans for your brands., • Collaborate with cross-functional teams to ensure the successful execution of marketing campaigns and projects. Financial Oversight:, • Work with the Director, Operations to manage account budgets, forecasts, and financial performance., • Identify opportunities for revenue growth and cost optimization while maintaining profitability.Requirements:, • Bachelor's degree in Communications, Marketing, Business or other related field., • 8+ years of experience in pharmaceutical advertising managing the development of HCP and/or DTC promotional campaigns. Experience with new product launches and label updates is a plus., • Proven track record of building and managing client relationships, continuously delivering successful marketing solutions and achieving revenue growth., • Strong understanding of medical, legal and regulatory compliance and MLR submission and approval process in the United States and/or Canada., • Excellent communication, negotiation, and presentation abilities.

Job Description Why Join the HWP Group? Health & Wellness Partners, LLC (HWP), is a medical and scientific communications agency that collaborates with life science industry stakeholders to develop award-winning solutions that advance patient care and transforms scientific content into compelling live and virtual user experiences through digital platforms, congress engagement, and more. We bring clients, providers, and patients outstanding educational programming paired with innovative digital and interactive dissemination vehicles. We are committed to making a difference in health care and in the lives of our team members. We aim to provide every employee with a job they love in a culture focused on career growth, well-being, and community outreach. We have been recognized as both an MM&M Best Place to Work and an Inc. Best Workplace. For more information, visit thehwpgroup.com. What You Need to Know We’re seeking an experienced Account Director to join our Account Services team—someone who excels at cultivating lasting relationships with clients and key opinion leaders. In this role, you’ll partner closely with clients to translate their strategic goals and tactical plans into impactful projects, while guiding internal teams to deliver exceptional results. You’ll lead cross-functional collaboration and oversee the daily operations within the agency, ensuring all deliverables align with client objectives, timelines, and budgets. What You’ll Do • Lead Project Execution: Manage projects from planning through delivery, acting as the central liaison between internal teams, external vendors, and stakeholders to ensure clarity around deliverables, timelines, budgets, and strategic goals., • Schedule & Risk Management: Communicate project schedules and updates to all stakeholders. Monitor progress to identify potential risks and implement mitigation strategies proactively., • Project Tools & Tracking: Utilize project management platforms to build and maintain timelines, tasks, milestones, and deadlines., • Team Alignment: Facilitate project meetings to ensure cross-functional teams are aligned on methodology, goals, and progress tracking., • Resource Allocation: Manage project resources within budget, flagging scope changes or out-of-scope requests to the Account Lead and client., • Documentation & Budgeting: Develop materials, statements of work (SOWs), program budgets, and reconciliations with precision and clarity., • Team Development: Support onboarding and training of Managers and Coordinators. Delegate tasks and oversee execution to ensure quality and timely delivery., • 3-5 years of account/project direction experience within a medical communications or medical advertising agency., • Familiarity with medical terminology and pharmaceutical products and knowledge of regulations and program implementation procedures, • High level of business acumen, financial awareness and negotiation skills, • Client intimacy mindset, • Experience in end-to-end project development, from ideation through implementation, • Proven ability in organic business development, including crafting tactical recommendations, • Expertise in Scope of Work (SOW) development and management, • Excellent oral and written communication and time management skills, • Proven strong interpersonal skills and the ability to participate constructively and effectively in meetings with a clear understanding of individual action items, • Proactive problem-solving skills in communications with internal teams and clients, • Proficiency in Microsoft® Office Suite, • 100% employer-paid medical, dental, and vision insurance, • 401k plan employer matching, • Eligibility for profit sharing, • Generous PTO, including a week off in December for the holidays, • Paid volunteer time off, • Tuition reimbursement, • Office locations in Upper Saddle River NJ, Red Bank NJ, and San Diego CA, • On-site gym and other employee wellness initiatives, • Casual work attire, • Comprehensive mental health services, • Leadership development training program and other career development programs, • Flexible hybrid and remote work schedule options

Aquestive Therapeutics is hiring directly for several key positions, with Inizio Engage supporting the recruiting process. About Aquestive Therapeutics With more than 20 years of pioneering patient-centered innovation, we've transformed how millions access life-saving medications. Our track record speaks for itself: 6 FDA approvals, 2.5 billion doses delivered worldwide, and a presence across 6 continents. As we prepare to launch Anaphylm™, our latest breakthrough in overcoming patient barriers, we're building a sales team that shares our commitment to innovation that matters. The Role As a Therapeutic Specialty Representative (TSR), you’ll be on the front lines of a critical product launch, introducing Anaphylm to healthcare providers. Anaphylm has the potential to be the first and only FDA-approved, non-invasive, orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis. If approved, people at risk for severe allergic reactions would have a device-free, needle-free epinephrine option. Similar in size to a postage stamp, Anaphylm is administered as a thin, dissolvable film placed under the tongue. As a Therapeutic Specialty Representative (TSR), you will educate healthcare providers on how Anaphylm is designed to address barriers that prevent patients from carrying and administering epinephrine, building trusted relationships to drive adoption of Anaphylm. This role is ideal for ambitious sales professionals who thrive in a launch environment and who want their work to have genuine clinical impact. Key Responsibilities Strategic Territory Development * Design and execute territory business plans that identify high-potential accounts and drive measurable market penetration * Analyze prescribing patterns, payer landscapes, and competitive dynamics to prioritize efforts and maximize ROI * Partner with Regional Sales Managers to align field execution with broader commercial strategy Clinical Education and Relationship Building * Deliver compelling, compliant clinical presentations that demonstrate Anaphylm's value in addressing unmet patient need * Build trust-based relationships with key prescribers, practice administrators, and healthcare stakeholders through consistent engagement and authentic dialogue * Navigate complex clinical objections with insight and empathy, positioning Anaphylm as the solution to real-world challenges Access and Pull-Through Excellence * Master payer coverage dynamics across your territory—national, regional, and local insurance landscapes * Collaborate with Market Access, to overcome prior authorization barriers and ensure seamless patient onboarding * Drive formulary wins and in-office pull-through by equipping providers with the tools and knowledge they need Flawless Execution * Orchestrate high-impact customer engagement programs including lunch-and-learns and speaker events * Maintain CRM excellence: capture detailed call notes, payer feedback, sampling activity, and strategic next steps with precision * Ensure 100% compliance with PDMA sampling requirements, AE/product complaint reporting, and promotional guidelines Field Intelligence * Serve as the eyes and ears of the organization, sharing customer insights, competitive intelligence, and best practices that inform strategy * Contribute to a culture of continuous learning and improvement across the sales organization Qualifications Required * Bachelor's degree * 3+ years of pharmaceutical, specialty, or B2B sales success with proven track record of exceeding targets * Deep understanding of payer coverage, prior authorization workflows, and access barrier navigation * Strong analytical skills with demonstrated ability to translate data into actionable territory strategies * Willingness to travel overnight 50% for customer meetings, conferences, and sales meetings Preferred * Launch experience in specialty or allergy markets. * Specialty pharmacy or hub services background * Experience selling products that address medication adherence or administration barriers Who Thrives Here * Mission-driven achievers motivated by outcomes results-oriented with passion for improving patient outcomes * Strategic hunters who combine creativity, persistence, and disciplined execution to drive market growth * Resilient and adaptable performers able to navigate obstacles, adapt quickly, and thrive in a competitive, fast-paced launch environment * Collaborative team players who elevate others while maintaining accountability for outcomes * Consultative and influential communicators who earn trust, educate customers, and drive conversion through insight and conveying value Compliance * Ensure field compliance with all company and industry standards, including: * Sampling and PDMA (if applicable) * Adverse Event (AE) and product complaint reporting * On-label and compliant promotional dialogue * CRM data quality and timely documentation * Maintain alignment with corporate policies, training, and legal/regulatory requirements. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected salary range: $125,000 - $150,000/per year. Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended as an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Job Description The Veterinary Technician assists the veterinarians with patient care and treatments, dental procedures, surgeries, immunizations, euthanasia as well as client education, marketing and inventory maintenance at North Haledon Veterinary Care. This position requires a working knowledge of pharmaceutical drugs, common diseases; their symptoms, means of transmission, treatment and prevention, and other basic preventative health care recommendations. This is an overview of the position and the job responsibilities listed do not encompass the entire position. PRIMARY JOB RESPONSIBILITIES • Obtain and record patient histories., • Collect specimens and perform routine laboratory procedures., • Dispense and administer medications, vaccines, serums and treatments as prescribed by veterinarians., • Administer fluids as prescribed by the veterinarian., • Administer and monitor anesthesia under the direction of a veterinarian., • Provide specialized nursing care for injured or ill animals., • Prepare patients, instruments and equipment for surgery., • Assure that monitoring and support equipment such as anesthetic machines, cardiac monitors, scopes and breathing apparatus are in good working condition., • Assist in diagnostic, medical and surgical procedures using a range of high-tech diagnostic equipment including electrocardiographic, radiographic and ultrasonographic equipment., • Take radiographs., • Communicate with and educate owners., • Maintain knowledge of preventative healthcare recommendations in order to answer client questions, provide education on vaccines, flea and heartworm products, and assist in marketing veterinary services from which their pet would benefit, such as a dental cleaning, senior wellness, spay and neuter and boarding., • Educate clients on products and medications sold including dietary products and answer questions regarding product purchase/use., • Maintain inventory of pharmaceuticals, equipment and supplies., • Clean, maintain and sterilize instruments, equipment, and materials., • Knowledgeable regarding related federal and state animal health laws and regulations including OSHA and DEA. Ensure that the hospital and its employees are in compliance with regulations. Inform the veterinary hospital administrator of any regulatory issues., • Work well with all team members and ensure that your actions support the hospital, the doctors, and the practice philosophy., • Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar., • Perform other duties as assigned. CONTROLS OVER WORK The Veterinary Technician works under the direct supervision of the Staff Manager(s) and Veterinarians who will indicate general assignments, limitations and priorities. Recurring assignments are performed independently. Deviations or unfamiliar situations are referred to the supervisor. Completed work is reviewed for technical accuracy and compliance with established procedures. SKILLS AND KNOWLEDGE • Knowledge of the procedures used for receiving, treating, and scheduling patients, for ordering medical supplies, and requesting laboratory tests., • Knowledge of the use, care, and storage of veterinary instruments, materials, and equipment., • Knowledge of sterilization techniques to sterilize various instruments and materials., • Knowledge of the instruments, materials, and standardized procedures used in the full variety of treatments to make preparations and provide “tableside” assistance., • Knowledge of principles and processes for providing client and personal services. This includes client needs assessment, meeting quality standards for services, and evaluation of client satisfaction., • Knowledge of commonly used veterinary terminology (e.g. terms of anatomy, physiology, diseases, tests, etc.) in order to accurately enter specific information into patient records. Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar., • Ability to work independently on assigned tasks as well as to accept direction on given assignments. The physical demands described here are representative of those that must be met by an employee to successfully perform the primary functions of this job. • Frequently required to bend, stand, stoop, walk, sit, talk, and listen, frequently working in a bent position. Standing for greater than 8 hours., • Frequently use hands to manipulate, handle, or feel; will reach with hands and arms., • Use strength or agility in capturing and restraining stronger, more active animals., • Frequently lift and/or move up to 50 pounds. Occasionally handle dogs weighing up to and over 150 lbs. Assistance will be provided by animal handlers when working with larger animals. WORK ENVIRONMENT While performing the duties of this job, the employee is exposed to hazards associated with aggressive patients; hazards associated with infected animals and controlled substances; exposure to unpleasant odors and noises; exposure to bites, scratches and animal wastes; possible exposure to contagious diseases. Follow federal and state animal health laws and regulations including OSHA and DEA. Note: When duties and responsibilities change, job description will be reviewed and subject to changes of business necessity. Essential Functions: • Receive, handle and treat patients with skill, compassion and care including: monitoring during anesthesia, administering fluids, assisting in diagnosing, surgery and general and specialized nursing care., • Accurately perform laboratory tests., • Accurately dispense and administer medications and vaccines., • Input data into computer software system., • Ability to observe animal appearance and activity for general physical condition, obvious signs of illness, disease and discontent., • Regular attendance and timeliness are an essential function in order to fulfill the requirements of this position., • Strong communication and client service skills. Considerable tact and diplomacy is required. Ability to work with clients and patients in a professional, friendly, hospitable manner., • Work well with all team members and ensure that your actions support the hospital, the doctors, and the practice philosophy., • Perform general physical activities that require bending, standing, stooping, moving from room to room, sit, talk, and listen; may be required to walk or stand for long periods of time (greater than 8 hours); will use hands to manipulate, handle, or feel; will reach with hands and arms., • Frequently lift, carry and handle dogs weighing 50 lbs., • Present yourself in a clean and orderly fashion, properly uniformed.

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 DescriptionDescription: Under the direct supervision of the Chief Medical Officer, the Optometrist provides direct clinical care to patients at the health center. The Optometrist is a member of the Care Team with the purpose of providing evidenced-based and quality medical care to Zufall Health Center patients. Essential Functions, Duties, and Responsibilities • Provides eye care services for patients of Zufall Health, including but not limited to comprehensive eye examinations, diagnosis and management of ocular diseases, prescription of corrective lenses (if applicable), referral to ophthalmologists or other specialists when appropriate, and other duties as assigned. Ensures continuity and quality of patient care., • Leads and collaborates with assigned clinical support staff to deliver exceptional and accessible preventive, acute, and chronic eye care to a diverse patient population. Educates patients and families about eye health and vision care., • Participates in extended service hours including occasional evenings or weekends as scheduled. Adjusts availability as needed to support patient demand and clinic operations., • Assists patients in obtaining additional services such as low vision aids, specialty referrals, or surgical consultations. Works closely with the Chief Medical Officer to build relationships with external providers, optical labs, and vision care networks to enhance patient access and care coordination., • Participates in clinical quality improvement initiatives and peer chart reviews as assigned. Attends and contributes to regular medical staff and team meetings as deemed necessary by leadership., • Supports clinic operations by maintaining compliance with all applicable local, state, and federal regulations. Ensures that licensure, certifications, and continuing education requirements are current. Adheres to and helps refine clinical protocols and practice guidelines., • Participates in community outreach including vision screenings, health fairs, and educational workshops. Supports staff training, mentorship, and may precept optometry students or interns as needed., • Maintains professional affiliations and stays informed of advancements in optometric care, techniques, and public health concerns. To perform successfully, the individual must be able to perform the essential duties satisfactorily. The requirements below are representative of the knowledge, skill and ability required. • Doctor of Optometry (OD) degree from an accredited optometry school., • Strong verbal and written communication skills., • Ability to work effectively with a diverse range of patients and colleagues., • Flexibility and commitment to working variable hours as required to meet clinic needs., • Proficiency with EHR systems and general computer applications including Microsoft Word and Excel., • Bilingual and/or bicultural candidates are highly valued; ability to speak both English and Spanish strongly preferred., • Doctor of Optometry (OD) from a program accredited by the Accreditation Council on Optometric Education (ACOE)., • Active license to practice optometry in the state of New Jersey, in good standing., • Certification to use therapeutic pharmaceutical agents (TPA) as required by New Jersey regulations., • National Provider Identifier (NPI) and eligibility to participate in Medicare, Medicaid, and other health programs., • Current BLS certification; other certifications (e.g., Advanced Procedures, Low Vision) may be preferred depending on clinic scope., • Minimum 1 year of post-graduate clinical experience preferred; new graduates with strong clinical training may be considered.

Job Description NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. Japan. Job Summary: Responsible for the management and execution of various aspects of translational and early-stage clinical studies (implementation, site selection, patient recruitment, vendor selection and oversight, tracking clinical data, etc.) for global clinical studies with adherence to all relevant regulations including FDA, ICH and Regulatory requirements. This is a hybrid position that requires to be in the Paramus office twice a week. Essential Duties and Responsibilities: • Develop and deliver program level translational and early-stage clinical drug development strategy, • Design, plan and execute biomarker strategies to inform indication priorities, commercial differentiation, regulatory strategies, biomarker qualification plan, and that achieve biomarker-driven milestones, such as target engagement, measurement assay development and validation, pharmacodynamic activity, and other biomarker contexts of use in clinical-stage programs, • Integrate with colleagues in discovery research and research-stage project teams to identify translational biomarkers and demonstrate preclinical target engagement, methodology of detection and measurement, proof-of-mechanism, pharmacodynamic activity, PK/PD relationships., • Plan, implement, manage and report for regional or global clinical studies., • Manage and Lead selection process of CROs for regional or global clinical studies., • Direct, oversight and manage the performance of study vendors (e.g. CROs and central labs)., • Provide direction and guidance with the Clinical Lead to achieve project objectives., • Manage and resolve project performance issues (issue management) if they arise., • Manage activities for clinical site selection, investigator meetings and study initiation., • Oversight of patient recruitment and development of recruitment strategies and plans., • Responsible for the creation of study related documentation (protocol, ICF, CRF, operations manuals etc.)., • Tracking clinical data, regulatory documents, and patient enrollment information and data resolutions to assure the timely completion of clinical studies in line with approved clinical development plans., • Assure compliance of investigational sites with SOPs, FDA regulations and ICH guidelines to assure that the studies are carried out fulfilling the requirements of the study protocols., • Manage negotiation of clinical trial contracts between investigational sites and CROs., • Oversight of data management vendors and statistical analysis vendors to ensure timely analysis output delivery in accordance with Statistical Analysis Plan., • Responsible for coordination with clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies to clinical sites., • Implement project specific training program and training materials, • Create and maintain clinical SOPs and TMF as part of global QMS and TMF processes., • Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, NS Pharma Japan (HQ), external partners and vendors., • Experience in negotiating Master Service Agreements, Project Specific Contracts and Budgets., • Good cross-functional team leader who fosters team spirit and team motivation (teamwork), • Thorough understanding of clinical operations involved as related to the planning, launching, and closing clinical studies., • Ability to anticipate and timely escalate issues and to define appropriate action plans, • Decision-making and problem-solving skills, • Ability to handle multiple tasks and prioritize, • Strong organizational, communication and presentation skills, • PhD and/or MD with 8+ years of experience in pharmaceutical or biotech R&D. MS or BS with 12+ years of R&D experience with progressive levels of team leadership also considered., • Preference for those with 5+ years’ experience as a Translational lead for clinical programs. Experience with Ph2/3 or registrational programs desired., • Excellent understanding of drug development, regulatory processes and clinical development NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $175,000 to $220, 000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit. Other benefits include: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs, • Discretionary Bonus Programs and Long-term Incentive Plan, • Retirement Savings 401k with company match, • Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown., • Career Development, Progression and Training NS Pharma is an EEO employer.

POSITION SUMMARY: Looking for candidates at Chemist I, II and III levels responsible for carrying out analytical method validation/verification activities and testing for Oral Solids, Oral Liquids, Topicals and Powders. MAJOR DUTIES/RESPONSIBILITIES: • Develop/Validate/Verify analytical (HPLC, GC, ICP-MS/OES, other) methods for assay and impurities determination in drug substances and drug products., • Perform wet chemistry and chromatographic testing for raw materials and products under development phase, • Perform stability studies for drug products in development phase and generate reports, • Develop and validate cleaning methods and generated study protocols and reports, • Prepare relevant protocols, reports, and final methods, • Maintain proper instrument calibration status, • Ensure that work is carried out safely and in compliance with the organization’s quality system, • Ensure that quality documentation is generated and updated to reflect current best practice in a timely manner., • Perform peer review at Chemist III level, not required if you’re applying for Chemist I/II levels., • Perform other duties as assigned. MINIMUM/PREFERRED REQUIREMENTS: Education: Bachelor or Master’s degree in science or Pharmaceutics. Experience: Bachelor’s with 2-7 years of experience in a generic pharmaceutical analytical lab. Master’s is preferred. Candidates shall be considered for different positions based on educational qualification and experience. Good understanding of cGMPs is a must for experienced candidates. PHYSICAL DEMANDS/ENVIRONMENTAL CONDITIONS: • Laboratory and office environment, • Able to lift about 25 pounds., • Able to stand and or sit for longer period of time. On-site, Full-time, Day Shift

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

EVERSANA has partnered with Mitsubishi Tanabe Pharma America, Inc. for this Direct Hire opportunity. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japan’s most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), amyotrophic lateral sclerosis (ALS), and is currently developing medicines in Neurology in Parkinson’s (PD), Spinal Cord Injury (SCI), and in high unmet areas in Immunology and Oncology. MTPA is rapidly expanding its operations across all functional areas. MTPA’s commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets. In the United States, MTPA launched rare disease treatments including RADICAVA® (edaravone) injectables in 2017 and RADICAVA® (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, supply chain, and business development functions. MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness. Job Description Direct Hire Opportunity! The Senior Director, Trade & Distribution, will build, lead, and manage the team while focusing on developing strategies to support the launch and lifecycle management of our leading Parkinson's and ALS therapies, as well as future products in the United States. The primary responsibility of the Senior Director Trade & Distribution is to develop and implement the distribution strategies across the specialty businesses. This includes specialty pharmacies, distributors and all channels that would support any present or future MTPA products. This person will have an intimate knowledge of the distribution systems from all aspects including durable medical equipment. The ideal candidate will possess strong leadership experience in managing teams that work both directly and indirectly with specialty vendors, coupled with exceptional analytical skills to identify operational gaps and implement effective solutions. Cross-functional collaboration with supply chain, marketing, sales, and customer-facing teams will be key to success in this role. Responsibilities • Provides overall leadership and direction for Trade Market Access strategy for Mitsubishi Tanabe Pharma US’ lead Parkinson and ALS products, • Evolve and innovate distribution network by aligning it with business needs, identifying growth opportunities, and addressing operational gaps to overcome challenges and drive access. Serves as the Distribution and Trade Strategy Team Leader, representing, • trade across all teams and driving key success factors to support long-term distribution strategies. Lead the development and execution in Federal Markets, including VA and Department of Defense to drive product access, distribution, and growth. Act as subject, • matter expert from a Market Access perspective for 340B program and other government programs., • Informs senior and corporate executives informed about changes and emerging issues in the broad, trade customer environments and subsequent implications for Mitsubishi Tanabe Pharma US, • Develops awareness of market and government policy changes in collaboration with legal and compliance and implications across key stakeholders to help inform/update commercial strategies, • Assists market access marketing agency (and other vendor relationships) to develop promotional programs, tactics and materials aligned with our distribution process, • Develops/maintains thorough understanding of dynamics driving various market access segments and channels and how distribution impacts each function, • Effectively manages budgets and project timelines including contract management, • Oversight in the negotiation, execution, and adherence to the Distribution Service Agreements (DSAs), Product Purchase Agreements, and other contract offerings as appropriate, • Develop account metrics against strategic, financial, and product access KPI’s, • Develops and monitors KPIs, continually assessing impact and execution of access services & offerings including feedback from service users and internal stakeholders, • Attends professional, provider programs, and patient conferences, and keeps up to date on innovation and recommends ways to improve business., • This is a home office based position. The expectation is to be in the office 3 days a week. Qualifications • Bachelor’s Degree Required, Masters preferred, • Must have 15 plus years within the pharmaceutical industry and 10 years’ experience in Distribution, Account Management or Aligned Market Access functions., • Experience with distribution for early-stage pipeline programs, • Experience in Federal Markets including VA, Department of Defense and 340B Program preferred., • Device/Drug combination strongly preferred, • Minimum 5 years of people management experience required, • Track record of closing complex negotiations within the specialty pharmacy arena, • Preferred experience includes:, • All aspects of distribution, • Launch and life cycle management for the distribution process, • Experience in Market Access marketing, • History of successful negotiations, • Broad based knowledge of the Pharma/Biotech industry, healthcare finance, and all forms of product distribution: DME, Orals, and Solutions, • Firm grasp of legal, regulatory and compliance issues in the healthcare space, • Analytical/strategic thinker with proven ability to:, • conduct situation analysis of the external distribution environment; synthesize relevant information to develop strategic plans, • understand the best pathway for distribution based on the product and its attributes, • conduct strategic gap analysis and implement metric-based solutions, • Strong interpersonal and internal/external relationship-building skills in order to drive change and innovation and succeed in a highly specialized distribution environment, • Excellent oral/written communication skills, coupled with exceptional presentation skills, including ability to present to large audiences, • Ability to prioritize and manage complex projects, with multiple stakeholders, and drive high-quality results within allotted budget, • Highly proficient in MS Office; advanced Excel skills Mitsubishi Tanabe Pharma America Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits. MTP provides a competitive benefits package inclusive of Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance and additional voluntary benefits such as Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection. In addition, we provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date.

Job DescriptionQuality Control Manager The Quality Control (QC) Manager plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that quality standards are upheld for all products produced at the facility. The goal is to ensure that the Quality Control group and company is constantly moving towards fulfilling its short-term and long-term objectives and does not diverge from its strategic guidelines. Under the direction of the VP, Global Quality Head, responsibilities of the QC Manager will include but are not limited to: • Leading, hiring, developing, training, and evaluating QC personnel, • Devising sound hiring strategies based on business needs, • Supervising and overseeing QC personnel in their roles for safe and efficient verification, approval, release/disposition of HCATS and/or client products/materials, • Delegating responsibilities and supervising the work of laboratory personnel, while providing guidance and motivation to drive maximum performance, • Ensuring and promoting compliance with applicable cGMP and GTP regulations, while ensuring compliance with company and client methodologies, • Assuring alignment and efficient continuity in laboratory practices between sites, • Serving as approver in investigations while overseeing timely closure of deviation reports, change controls, CAPAs, and applicable batch records, • Ensuring completion of all client QC requirements related to GMP cellular products and/or materials, • Overseeing QC role in material dispositions via deviation reporting system, CoAs, and/or client-based systems, if applicable, • Prioritizing, scheduling, and managing multiple projects and resources simultaneously, • Monitoring effectiveness of quality systems, change control activities and their completion, for both, internal and client audit findings, • Evaluating and investigating customer complaints and deviations; coordinating corrective and preventive actions as they relate to the Quality Control function, • Delegating maintenance, tracking, and trending aspects of the deviation reporting system, • Developing and maintaining Key Performance Indicators (KPIs) for laboratory testing, • Interfacing with vendors, suppliers, and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies, when applicable, • Interfacing with management at all levels for alignment on significant deviation resolution and corrective action implementation, • Delegating development, revisions, and implementation of Standard Operating Procedures as related to Quality Control activities, • Participating in and tracking group budget setting and cost containment drives, • Communicating and maintaining trust relationships with senior management, business partners, and clients, • Ensuring company policies and legal guidelines are communicated top-down in the company and that they are followed at all times, • Completing projects and special tasks as assigned by the Global Quality Head, • Off-schedule shifts during weekends and holidays based on business requirements a possibility, • On-call presence preferred while physical personal presence is not possible, • Candidate will oversee QC Scientist and QC Associate I, II, and III roles. The QC Manager will delegate responsibilities to direct reports to achieve the requisite business needs, while providing ongoing support to Manufacturing processes.REQUIREMENTS, • BA/BS/MS in a science or relevant field required, • Master’s in Business Administration or relevant field will be preferred, • 7 – 10 years’ experience in the pharmaceutical, biologics or related industry, • Prior cGMP experience required, • Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment a must, • Experience in Flow Cytometry is a must, • 5 + Years experience leading a team is a must. Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff, • Sound understanding of current Good Manufacturing Practices (cGMPs), • Working knowledge of routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, equipment and systems, and understanding of production processes and validation, • Prior experience with reviewing Standard Operating Procedures, work instructions, protocols, methods, method validations preferred, • Proven experience in a supervisory or managerial position, • Demonstrable experience in developing strategic plans based on business needs, • Strong understanding of Quality Control in pharmaceutical/biotechnology/biologics industries, • Thorough knowledge of market changes and forces that influence the company, • Proficient with computer software: Microsoft Office, Visio, • Strong written, oral, and presentational skills, • Strong knowledge of QC Analytical testing methodologies, philosophies, method validation and method transfers, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review, • Excellent organizational and leadership skills, • Excellent communication, interpersonal, and presentation skills, • Outstanding analytical and problem-solving abilities, • Strong business acumen, • Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner, • Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Must have the ability to work in a team-oriented environment and with clientsMust be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job 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 DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description Talent will be hired at a level commensurate with experience. This geography covers the following states: NY, MA, CT, NJ, NH The Rheumatology Regional Marketing Manager (RMM) will work closely with multiple AbbVie cross-functional teams to ensure collaboration, alignment, and successful development of area marketing strategy and execution. This field-based marketing role will be responsible for the optimization of national and regional marketing initiatives, ensuring alignment with Annual Strategic Brand Plans. The RMM will act as the face of the AbbVie Marketing team with our External Experts, developing, implementing, and maintaining interactions for the purpose of insight generation within assigned geographies. Additionally, the RMM works within a team-based environment to optimize brand performance across AbbVie Rheumatology. Key Responsibilities: Strategic Marketing • Lead projects compliantly and effectively through the promotional review process to deliver high-quality work in a timely fashion (meets deadlines). Ensures that regulatory guidelines and AbbVie processes are followed, • Manage strategy, execution and budgeting for national and regional conventions, External Expert consulting, advisory boards, and commercial peer-to-peer education programming., • Continually applies knowledge and evaluates the effectiveness of key marketing tactics, making strategic recommendations to leadership on opportunities for brand optimization, • Ability to provide in-depth insights based on the brands key business questions to provide input on marketing strategy, resource optimization and tactic development that drives brand performance, • Lead partnerships with field leadership in assigned geography to optimize pull-through of marketing strategies, • Responsible for understanding a geographical area’s competitive landscape, provider dynamics and competitive intelligence across the assigned geography, • Identify, build, and strengthen commercial relationships with External Experts, emerging leaders, and relevant patient and professional associations within assigned geography, • Develop regional engagement plans for External Experts and ensure consistent tactical execution throughout the year to drive key marketing engagement, • Mastery of verbal and non-verbal communication and presentation skills, live and virtual, to effectively engage internal leadership and external stakeholders, • Experience working in a collaborative working environment with integrated, cross-functional teams by understanding priorities, key responsibilities and influencing without direct authority to drive results, • Ability to navigate a field and headquarter based matrix organization, to impact and/or drive decision making across functions to drive strategy and brand performance, • Ability to work in a fast-paced environment, • Knowledge of applicable regulations and standards affecting Pharmaceutical ProductsQualifications, • Bachelor’s Degree, • Previous experience in sales, sales management, or marketing with at least 2 years of experience in Rheumatology/Immunology (preferred), • Travel up to 60% of the time including evenings and weekends, • Driving a personal auto or company car or truck, or a powered piece of material handling equipment, • Valid driver’s license: Ability to pass a pre-employment drug screening test and meet safe driving requirements Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

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

Job Description NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan. Summary: Manage and support the execution of assigned global clinical studies with adherence to all relevant regulations including FDA, ICH and Regulatory requirements. Essential Duties and Responsibilities: • Assist to plan, implement, manage and report for regional or global clinical studies., • Manage selection process of CROs for regional or global clinical studies., • Manage the performance of study vendors (e.g. CROs and central labs), • Manage activities for clinical site selection, investigator meetings and study initiation., • Oversight of patient recruitment and development of recruitment strategies and plans, • Support for the creation of study related documentation (protocol, ICF, CRF, operations manuals, etc.), • Tracking of clinical data, regulatory documents, and patient enrollment information and data resolutions to assure the timely completion of clinical studies in line with approved clinical development plans., • Assure compliance of investigational sites with SOPs, FDA regulations and ICH guidelines to assure that the studies are carried out fulfilling the requirements of the study protocols., • Coordinate negotiation of clinical trial contracts between investigational sites and CROs., • Manage assigned vendors to ensure timely analysis output delivery in accordance with vendor-specific plan., • Support coordination with clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies to clinical sites., • Implement project specific training program and training materials, • Support creating and maintaining clinical SOPs and TMF as part of global QMS and TMF processes., • Perform tasks administrative in nature (e.g. coordination, schedules, submission, filing, etc.)., • Must be able to manage and coordinate with the Clinical Lead and Study Manager to achieve project objectives and able to manage/solve project management performance issues if they arise., • Demonstrated ability to support the development and management of various aspects of the end to end study operational plan., • Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, Head Office in Japan, external partners and vendors., • Thorough understanding of clinical operations involved as related to the planning, conducting, and closing clinical studies., • Ability to handle multiple tasks and prioritize., • Strong organizational, communication and presentation skills., • Team player, flexible, ability to adapt to change., • Bachelor’s Degree in sciences or related field with a minimum of 3 to 5 years of pharmaceuticals/biotech experience., • Minimum of 3 to 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials., • Program and project management experience preferred. Compensation And Benefits: NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $110,000 to $135,000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit. Other benefits include: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs, • Discretionary Bonus Programs and Long-term Incentive Plan, • Retirement Savings 401k with company match, • Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown., • Career Development, Progression and Training, • Flexible Work Arrangement Programs Applications will be accepted until January 19, 2025, or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma. NS Pharma is an EEO employer.

Job DescriptionCompany Description Swiss Delivery Excellence: Transforming Life Science Consulting Worldwide. Fusion Consulting is a globally leading Business and IT boutique consultancy specialized in the Life Sciences industry, partnering with leading companies in pharma, healthcare, and animal health. With over 450 employees and 25 offices worldwide, our mission is to revolutionize our clients' business transformation challenges and set new industry standards through innovative solutions. Focused on S4HANA, Data & Cloud, and innovative technologies, Fusion Consulting brings unparalleled expertise and commitment to excellence to every project we undertake. Grounded in our commitment to fast and intelligent decision-making, our client-first and open-hearted approach defines our ethos. With unwavering support and an entrepreneurial spirit, our global teamwork transcends boundaries and turns shared visions into reality. Job Description We are seeking a skilled and detail-oriented Data Modeler to lead the design and alignment of the global data model for the Veeva Network platform as part of our 2026 implementation. This role will be instrumental in defining how accounts, contacts, and hierarchies are structured and governed across all markets, ensuring data consistency, integrity, and compliance. The ideal candidate brings a strong background in data architecture, metadata governance, and stakeholder collaboration, with experience working in complex CRM and MDM environments. Key Responsibilities: • Design and maintain the global data model for Veeva Network, focusing on Accounts, Contacts, and Hierarchies., • Define which CRM fields are included/excluded from Veeva Network and their categorization (e.g., auto-synced vs. steward-reviewed)., • Analyze region-specific or dual-purpose CRM fields to align with appropriate Veeva Network attributes., • Ensure harmonization of data definitions and model structure across all markets., • Collaborate closely with global data governance teams and the Global DDO for Customer Contact., • Establish stewardship and governance rules within Veeva Network for controlled data flows.Qualifications Must-Have Skills and Competencies: • Proven experience in data modeling within CRM or MDM systems., • Strong understanding of data architecture principles, data governance, and harmonization strategies., • Familiarity with Veeva Network or equivalent life sciences data management platforms., • Ability to interpret and align complex global and regional data requirements., • Excellent analytical thinking, documentation, and stakeholder communication skills., • Prior experience in the pharmaceutical or life sciences industry., • Understanding of regulatory requirements for customer data in global organizations., • Experience working with the Global Data Domain Owner (DDO) framework., • Proficiency with data modeling tools and platforms such as ER/Studio or SAP PowerDesigner. Additional Information WHY YOU SHOULD JOIN FUSION: At Fusion, you’ll join a diverse team of talented professionals from around the world, united by a passion for delivering impactful digital transformation in the life sciences industry. You’ll be part of a flat-structured, collaborative organization where decisions are made efficiently, and your expertise directly shapes client outcomes. You’ll work alongside experienced consultants on complex, meaningful projects that demand both precision and innovation. Our culture emphasizes continuous learning, open knowledge sharing, and cross-functional teamwork—empowering you to grow both professionally and personally. Joining Fusion means becoming part of a company that: • Builds strong, trusted partnerships with clients, delivering tailored solutions that create real business value., • Drives delivery excellence, holding ourselves accountable for the quality and impact of every outcome., • Encourages entrepreneurial thinking, empowering you to take initiative, solve problems, and lead change. We’ve designed our benefits to support your growth, well-being, and global mobility. Flexibility & Balance • Work from Anywhere: Enjoy up to 25 days per year of remote work from any global location., • Connect as a Team: Use your team’s integration budget to meet, collaborate, and bond., • Invest in Your Learning: Access annual training budget for professional development., • Grow Your Skills: Join regular workshops and trainings to strengthen technical and soft skills., • Advance Continuously: Build the mindset, confidence, and capabilities to grow your career on your terms., • Earn What You’re Worth: Receive a competitive salary and benefits package that reflects your impact., • Refer Talent: Get rewarded for recommending new hires through our referral program., • Navigate Global Moves: Get help with visas, permits, and international assignments., • Benefit Locally: Enjoy perks tailored to your country of residence. Your time is valuable. That’s why our hiring process is clear, efficient, and focused on mutual fit: Upload Your CV – Submit your application using the relevant button, depending on the job platform (approx. 3 minutes). Wait for Profile Review – Our Talent Acquisition team will assess your CV and experience (approx. 2 weeks). Join an Introductory Call – Our Talent Acquisition team will arrange a brief conversation (15–30 minutes via Teams or phone) to tell you more about Fusion, the role, and understand your expectations. Attend a Technical Interview – Participate in a 30-minute session with one of our experts to discuss your skills and experience in more detail. Participate in a Client Interview (if applicable) – For some roles, you may be invited to a client-facing discussion (30–60 minutes online). Receive Final Feedback – We aim to share timely feedback and move forward quickly. Fusion is an equal opportunity employer. We value diversity and are committed to fostering an inclusive workplace for all.

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

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

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

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

Job DescriptionJob Title: REMOTE Territory Sales Manager – Specialty Chemicals & APIsCompensation: $100,000–$130,000 base + performance incentives Location: Remote (U.S.) Industry: Specialty Chemicals / APIs / Pharmaceutical Intermediates Overview A global manufacturer of specialty chemicals and pharmaceutical ingredients is expanding its North American commercial team. This is a high-impact sales role focused on growth within key verticals including iodine derivatives, intermediates for anti-cancer and contrast media, and active pharmaceutical ingredients (APIs). The role is modeled on a proven sales structure used for similar markets, emphasizing relationship management, business development, and strategic positioning across nutraceutical, pharma, and fine chemical sectors. Key Responsibilities * Drive sales growth across the North American territory for specialty and pharmaceutical-grade chemical ingredients. * Identify, target, and close new business opportunities across the following categories: * Iodine derivatives * Anti-cancer drug intermediates * X-ray and contrast media intermediates * APIs and stomach-related APIs * Develop and maintain relationships with key accounts, distributors, and manufacturers. * Collaborate closely with global production and regulatory teams to ensure compliance and delivery. * Analyze market trends and identify high-value prospects for long-term partnerships. * Represent the company at key trade shows and industry events (e.g., IBIE, CPhI, SupplySide West). * Prepare detailed reports and forecasts for executive management. Qualifications * Bachelor’s degree in Chemistry, Chemical Engineering, or related field (advanced degree a plus). * Minimum 5 years of experience in B2B sales of specialty chemicals, APIs, or pharmaceutical intermediates. * Proven track record of achieving revenue goals and building strategic partnerships. * Familiarity with regulated markets (FDA, REACH, GMP) preferred. * Exceptional communication, negotiation, and presentation skills. * Self-motivated, entrepreneurial mindset; able to operate with minimal supervision. Compensation & Benefits * Base salary between $100,000 and $130,000, depending on experience. * Performance-based commission and annual bonus structure. * Health coverage, paid time off, and travel reimbursement. * Long-term growth opportunity with a global chemical leader expanding in the U.S. market.

Job Description Why Join the HWP Group? Health & Wellness Partners, LLC (HWP), is a medical and scientific communications agency that collaborates with life science industry stakeholders to develop award-winning solutions that advance patient care and transforms scientific content into compelling live and virtual user experiences through digital platforms, congress engagement, and more. We bring clients, providers, and patients outstanding educational programming paired with innovative digital and interactive dissemination vehicles. We are committed to making a difference in health care and in the lives of our team members. We aim to provide every employee with a job they love in a culture focused on career growth, well-being, and community outreach. We have been recognized as both an MM&M Best Place to Work and an Inc. Best Workplace. For more information, visit thehwpgroup.com. What You Need to Know We’re looking to add an Associate Medical Editor to our Editorial Services team. The Associate Medical Editor role is entry-level and is ideal for individuals with minimal experience in editorial tasks or the healthcare/pharmaceutical industry who are eager to develop their expertise in medical editing. This role will work under supervision to gain proficiency in proofreading, copyediting, and applying the AMA Manual of Style (11th Edition) while becoming familiar with our agency’s tools, systems, and workflows. What You’ll Do • Proofread and copyedit a variety of scientific and medical materials, including manuscripts, slide decks, abstracts, and educational content for healthcare professionals and patients, • Ensure grammatical accuracy, consistency, and adherence to style guides (including AMA Manual of Style), • Verify that content aligns with scientific data, regulatory requirements, and client objectives, • Collaborate with medical writers, designers, project managers, and account managers to enhance the clarity and quality of deliverables, • Assist in maintaining consistency and compliance with ethical and industry standards, • Manage multiple projects under tight deadlines while ensuring high editorial standards What You’ll Have • Internship to 1 year of experience in an editorial capacity, • Bachelor's degree in English, Journalism, Communications, Life Sciences, or a related field, • Proficiency in Microsoft Office Suite; familiarity with editing tools and content management systems is a plus, • Strong attention to detail and ability to spot grammatical, stylistic, and factual inconsistencies, • Basic familiarity with medical terminology and scientific content is preferred, • Ability to learn quickly and work under supervision to develop expertise in medical editing, • Excellent time management and organizational skills to handle multiple projects What We Offer • Immediate eligibility for all benefits, including medical, dental, vision, group term life, short-term and long-term disability, • Benefits 100% company paid, • 401k plan employer matching contributions, • Eligibility for company sponsored incentive plans, • Generous PTO, including a week off in December for the holidays, • Paid volunteer time off, • Tuition reimbursement, • On-site gym and other employee wellness initiatives, • Employee Assistance Program, • Comp pay or comp time for onsite weekend work, • Availability of cell-phone stipends, based on business need, • Leadership development training program and other career development programs, • Remote and hybrid work schedule options, • Salary range: $50,000 – $60,000 annually. Note: Actual salary will depend on background and experience. M/F/D/V Please note, we will only respond to candidates we deem qualified

Job Description SUMMARY: • 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, • Regulatory Documentation: Author and review CMC sections of regulatory submissions, including IND, NDA, and MAA applications., • Compliance & Guidelines: Ensure documents align with FDA, EMA, and ICH regulatory requirements., • Collaboration: Work closely with scientists, regulatory affairs teams, and manufacturing experts to gather accurate data., • Quality Assurance: Maintain consistency, clarity, and accuracy in technical writing. Education: Bachelor's or advanced degree in chemistry, pharmaceutical sciences, or a related field. Experience: • Prior experience in pharmaceutical or regulatory writing., • CMC (Chemistry, Manufacturing, and Controls) Writer experience.

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

Job Description Join a rapidly growing biopharmaceutical company specializing in Neurology and Psychiatry therapies. As a GCP Senior Auditor, you will play a key role in ensuring GXP compliance with global regulatory authorities, driving company-wide compliance initiatives, and strengthening quality management systems to minimize risk in a regulated environment. This role is ideal for a detail-oriented professional with strong Good Clinical Practice (GCP) experience and a passion for maintaining high-quality standards across global clinical operations. Key Responsibilities Audit Leadership & Compliance Oversight • Plan, conduct, and manage global clinical process and vendor audits across multiple trials., • Execute internal and external GXP audits, ensuring adherence to FDA, EMA, and ICH GCP guidelines., • Collaborate with clinical sourcing, supplier quality, and clinical partnerships to evaluate and manage CROs, CMOs, investigator sites, and other vendors., • Develop detailed audit reports and manage related non-conformance items., • Ensure alignment with corporate Quality Management Systems (QMS) and Standard Operating Procedures (SOPs)., • Support regulatory inspections by preparing documentation and participating in audit readiness activities., • Bachelor's degree in a scientific, healthcare, or related discipline., • Minimum 5+ years of experience in the pharmaceutical or biopharmaceutical industry., • Strong background in GCP auditing and safety/pharmacovigilance., • Demonstrated experience conducting and managing internal and external GXP audits., • Proven knowledge of FDA, EMA, and ICH GCP regulatory requirements., • Familiarity with QMS, SOPs, and compliance documentation., • Experience auditing CROs, CMOs, investigator sites, and clinical vendors., • Experience within a biopharmaceutical organization focused on neurology or psychiatry therapeutic areas., • Hybrid schedule: 3 days on-site (Tuesday-Thursday) in Paramus, NJ., • Flexibility is required as the on-site schedule may adjust over time., • Up to 10% travel may be required for audits and inspections.

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

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

Job DescriptionQuality Assurance Manager - ValidationAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. This position will report into the Associate Director of Quality Assurance responsible for the oversight and management of Quality Assurance Validation/Qualification activity. Responsible for managing the quality assurance validation activity such as development, implementation, and continuous improvement initiatives at two Allendale, NJ manufacturing sites. This role works to build, enhance, harmonize and manage quality assurance validation across sites and is responsible for finding solutions and coordinating change initiatives. Core responsibilities include, but not limited to, document management: review and approval of validation protocol, report, investigation report, assignment of CAPA, SOP development and revisions. Provides cross departmental support within Quality Assurance, as well as, collaborates with other Quality departments to support organizational and functional strategy. Develops and/or revises policies and procedures, as well as, supports operational excellence initiatives. Represents Quality Compliance in internal and external audits which may include interaction with regulatory health authorities and clients. • Functions as the sites Quality Assurance validation partner ensuring quality standards are enforced., • Partners closely with quality training staff in development of learning curriculum that drives compliance standards., • Oversees and manages the activities of validation team; provides leadership and direction to ensure that organizational and departmental goals are met., • Coordinates the investigation and closure of deviations with root cause analysis., • Ensures appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented., • Manages end-to-end delivery of quality document assuring compliance of company's quality standards., • Reviews and approves GMP documents such as investigation report, CAPA, validation protocols and reports, SOPs, change controls, etc., • Reviews and proposes changes to quality agreements., • Participates in ongoing quality system improvement programs and initiatives. Establishes Quality Validation KPI Reporting and Continuous Improvement metrics., • Participates in internal audits, regulatory agencies, and client audits., • Provides technical information during tech transfer activities to ensure all quality requirements are met according to current industry standard., • Establishes departmental KPIs in alignment with organizational goals and objectives., • Plans and allocates resources to effectively staff and accomplish the work to meet departmental productivity and quality goals., • Plans, evaluates, and improves the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output., • Makes business decisions that are financially responsible, accountable, justifiable, and defensible in accordance with organization policies and procedures., • Establishes and maintains relevant controls and feedback systems to monitor the operation of the department., • Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees., • Provides oversight and direction to the employees in accordance with the organization's policies and procedures., • Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities., • Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback., • Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise., • Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization., • Leads employees to meet the organization's expectations for productivity, quality, continuous improvement, and goal accomplishment., • Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning., • Provides effective performance feedback through employee recognition, rewards, and disciplinary action, with the assistance of Human Resources, as necessary., • Maintains employee work schedules including assignments, job rotation, training, vacations and paid time off, coverage for absenteeism, and overtime scheduling., • Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, Instant Messaging (IM), and regular interpersonal communication., • Supervise 1-2 Direct Reports, • Other duties as assigned.REQUIRMENTS, • Bachelor of Science in biological sciences or other relevant field of study., • 5-10 years’ relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. 3+ years of recent supervisory experience required. Experience in both clinical and commercial manufacturing is preferred., • Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (investigation, validation/qualification reports, SOPs etc.), • Experience in organizing and leading teams., • Experience participating in health authority inspections and/or client audits., • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities., • Training; GXP, SOP & WI training, Safety, • Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit., • Must be able to foster and work in a team-oriented environment., • Must be able to work infrequently on 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.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 DescriptionJob Summary: Instrument and Controls Engineer:The Instrument and Controls Technician is involved with the successful daily operation of the oil refining facility, and the modification and alteration of the plants automated control and power systems to accommodate business needs and ensure high plant availability. This requires close collaboration with other employees and management staff to ensure safe work and to set or re-set job priorities. Documentation, as required to document changes in plant physical or logic changes, and documentation to meet our goals of safety first, quality work and compliance with our customers’ requirements and concerns. Qualifications: Instrument and Controls Engineer: • High School Diploma or GED with at least 10 years I&E (I&C) experience in a chemical, food, pharmaceutical manufacturing environment. Familiarity with PLC based controls systems such as GE or Allen Bradley in a manufacturing environment., • Ability to analyze and interpret technical problems related to instrumentation or PLC logic., • Ability to read and understand company policies and procedures, technical datasheets or literature, P&IDs, electrical drawings (One-line drawings, loop drawings, control circuits, etc), • Ability to effectively present information either verbally or via written document (e-mail, MS Word/Excel, CMMS, etc) and respond to questions from groups of managers, co-workers, customers, and the general work force., • Ability to work with and apply mathematical concepts to practical situations., • Preferred: New Jersey Licensed Electrician (or working towards license), • Preferred: ISA Certification (Certified Control System Technician, Certified Industrial Electrician, Certified Instrument Technician)Duties & Responsibilities: Instrument and Controls Engineer:, • Monitor, repair, maintain and troubleshoot all field instrumentation, electrical equipment and controls systems including plant safety systems and plant power systems., • Install, loop check, maintain and troubleshooting process control systems comprised of transmitters, controllers, and valves operating in a PLC system., • Calibrate, monitor, repair, maintain, label and document all field instruments such as transmitters, controllers, valves, PLCs, plant safety systems, plant power systems, utility systems (HVAC), pH and conductivity meters, • Install, maintain, and troubleshoot electrical distribution and protection circuits up to 480VAC., • Fabricate and install rigid and flexible conduit, and run power and control wiring based on electrical code requirements, • Properly select, install and wire 120V-480V motors, single phase to three phase based on needs, • Strong working knowledge of National Electrical Code (NFPA 70), • Evaluate current instrumentation technology for process equipment and make recommendations for improvements., • Ensure all work orders are completed, documented and closed out in the site CMMS system, as per procedure., • Provide on-call support during assigned weeks to ensure 24/7 coverage, • Provide practical solutions to operations/ controls problems., • Scope, estimate and execute small capital / maintenance projects along with maintenance manager/ project director/ operations, etc., • Train other employees considering their needs and company needs., • Oversee the work by contractors as required on site to ensure safe and quality performance.

Job DescriptionOur Biotechnology client located in Allendale, NJ is seeking a Human Resources Business Partner who will provide human resources consultation and support to the Quality Department. This position is both operational and strategic in nature and provides HR expertise in the areas of talent management, organization design and effectiveness, performance management, employee relations, employee engagement, compensation, retention and process improvement initiatives. This role reports to the Sr. Director, Human Resources and will serve as a business partner to the Quality Leadership team and function. In addition, this role supports, implements, and executes all tactical aspects of the HR function. • Understand business needs in order to assess the HR implications of various business strategies., • Acts as liaison to other functions to ensure achievement of business objectives., • -Provide staffing and placement support to departments and divisions., • Facilitates the recruitment and on-boarding process for all new hires. HR Leadership: Coaching, developing and providing guidance to HR team members within assigned groups.Business Partner: Serving as a true business partner and advisor, gaining the trust of the organization in order to influence and provide effective HR processes, advice and support.Talent Acquisition: designing and executing workforce planning and recruitment strategies that attract and retain the best talent in the industry.Organization Effectiveness: Serves as a change agent in the organization, sponsoring change initiatives in support of organizational evolution.Employee Relations: Promoting a philosophy of employee relations throughout the company which emphasizes open communications, equal opportunities and treatment, continuous learning and reflects our core values.HR SME: Acting as a subject matter expert within the organization and providing interpretation, recommended best practices and ensures compliance with key legal requirements and adherence to company policies and procedures.Compensation: Ensures our compensation practices continue to attract and reward top talent. Oversee the salary administration to include annual performance management and compensation processes.Continuous Improvement: Analyzing trends and metrics in partnership with the HR team to draw insights, develop solutions, programs and policies. REQUIREMENTS, • -Bachelor’s degree in business, Human Resources or related field., • Minimum of ten years progressive HR/business leadership experience is required., • Demonstrated ability to build credibility and confidence with a wide variety of employees and leaders as a trusted advisor and confidant., • Ability to influence individuals at all levels of the organization., • Strong problem solving and conflict resolution skills., • HR Certification (PHR, SHRM-CP) or ability to obtain certification within one year of employment., • Prior experience in working in a matrix and complex operating environment preferred. Fast paced, challenging industry, • Build strong relationships with peers and cross functionally with partners outside of team to enable higher performance., • Highly ethical, authentic and committed to high integrity., • Learns fast, while being adaptable to the changing environment., • Look to raise the bar of service delivery and always seeks ways to address the status quo looking for ways to improve., • Communication proficiency: for both written and verbal communication, • Work collaboratively with all levels of employees., • Flexibility and adaptable in a high pressured, clinical and/or pharmaceutical environment., • Work with a composed attitude and behaves accordingly., • Action oriented with results, executes on all assigned goals and objectives, • Must have high level of interpersonal skills to ensure accurate flow of all information.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 DescriptionManager Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Primary Processing Unit (PPU), Manager, Manufacturing Operations is responsible for efficient capacity utilization of site resources to meet customer demand. They will partner with support functions to deliver on customer demands. This leader is accountable for the management of client projects at the site and for delivery of results within project scope, agreed timelines, contract requirements, revenue targets, as well as compliance and regulatory requirements. The Manager, Manufacturing Operations is responsible for profit and loss within their PPU and will deliver on revenue. This role will also drive individual and team development to ensure a prepared and empowered workforce to become the provider of choice for the industry. • Meet client process demands through planning, scheduling, manufacture and delivery., • of clinical cell therapy products according to established procedures, regulations and contract., • Ensures manufacturing documentation is closed out in a timely manner in accordance with applicable regulations and per contract., • Ensures capacity availability of resources (room/equipment/staff) to perform clinical manufacture for clients per contract., • Ensures process hours are charged - tracked to meet contract and revenue targets., • Accountable for maintaining a mechanism to work with clients to troubleshoot problems, suggests improvements and determines & advocates for value-add projects., • Assures manufacturing space is kept in a clean, validated state in compliance with company procedures, GMP and applicable regulations, • Ensures on the job training program and resources for new associate (proficiency) training and cross training of existing staff., • Ensures a safe work environment for employees., • Ensures department staff compliance with corporate and site-specific HR policies, safety and business policies and practice., • Approves job specific curriculum for the training and professional development of department staff., • Holds regular staff and 1:1 meetings to emphasize corporate culture, maintain morale, and provides a forum for staff development and discussion., • Responsible for the profit and loss for the PPU, • Deliver on revenue, • Assures compliance with budget, • Liaison with support groups – supply chain, training, quality systems, and business development, • Partners with clients along with Project Management and team leadership; drives the account management and liaison with the clients, • Sets team expectations and goals and delivers the business direction for the PPU, • Sets KPIs & ROIs targets and assures PPU metrics are maintained and tracked monthly., • Coordinates with PPU leadership and team meetings and determines PPU strategy development, • Accountable for driving the spirit of continuous improvement, • Collaborates with Business Development to ensure compliance and contract requirements, • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Directly supervises the following roles: Associate Manager, Manufacturing, Manufacturing Associates, Lead Manufacturing Associates, Production Support Associates, Technical Trainers, Compliance InvestigatorsREQUIREMENTS, • Bachelor's degree (ie Biology, Biotechnology, Bioengineering, Chemical Engineering)., • 5-7 years of cGMP environment, aseptic processing, mammalian cell culture, cell processing, cryopreservation experience., • 5-7 years of leadership experience or equivalent combination of experience., • Strong business acumen, • Deep understanding of cGMP and cGLP, • Working knowledge of financial operations and budget development, • Relevant IT skills (Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities, • Drive to create and maintain order in a fluid technically complex environment, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • List required training that must be completed by incumbent in order to fulfill the responsibilities for this role. Examples can include aseptic techniques, gowning qualifications, manager training, GMP, etc., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the company, • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen, • Must have the ability to work in the cleanroom environment for extended period of time, • Must have the ability to work with specialized equipment, • May work with hazardous materials and chemicals, • Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Are you ready to shape the future of clinical development through data science and AI? We are seeking a visionary Executive Director of Biostatistics & Data Science to lead strategy and execution across our global clinical portfolio. This is a unique opportunity to drive innovation in neuroscience, including Alzheimer's disease and related biomarkers. About the Role As Executive Director, you will: Define and execute Clinical Data Science strategies for global development programs Serve as the primary data science representative to health authorities, influencing regulatory perspectives Drive adoption of AI/ML methodologies for disease modeling, biomarker analysis, and precision medicine Oversee large-scale initiatives ensuring timely, high-quality deliverables Represent the organization at industry conferences, shaping best practices Lead and mentor a global team of data scientists and managers Key Responsibilities • Strategic leadership in clinical trial design and data science integration, • Innovation in AI/ML applications for imaging, genomics, proteomics, and precision medicine, • Regulatory engagement and defense of data strategies, • Operational excellence in GxP compliance, vendor management, and budget oversight Qualifications • Ph.D. in Biostatistics, Bioinformatics, or related computational sciences, • 10+ years of experience in clinical development, data science, and biostatistics, • Recognized leader in AI/ML or precision medicine, • Proven regulatory engagement and external presentation experience, • Strong leadership skills with global team management experience Salary: $300-380,000 base salary + bonus + LTI #Biostatistics #DataScience #AIinPharma #ClinicalTrials #Neuroscience #DrugDevelopment #PrecisionMedicine #PharmaJobs #LifeSciences #LeadershipOpportunity Company DescriptionA top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints. Job Responsibilities: -\tConducting Post Market Activities and Post Market Surveillance -\tManaging Customer and Product Complaint Investigation programs Education and Experience: -\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry -\tBachelor's degree -\tComputer proficiencyA top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.\r\nJob Responsibilities:\r\n•\tConducting Post Market Activities and Post Market Surveillance\r\n•\tManaging Customer and Product Complaint Investigation programs\r\nEducation and Experience:\r\n•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry\r\n•\tBachelor's degree\r\n•\tComputer proficiency

Job Description About Us: Second Melody is a branding studio with a diverse client portfolio, including a strong presence in health and biotech. Our focus is strategic brand alignment across corporate messaging, internal culture, audience outreach, advocacy and education. Our mission is to help our clients solve problems by building stronger and more inclusive brands that accurately represent their visions, passions, and business goals. Role Overview: At Second Melody, we believe in building meaningful, lasting relationships with our clients and within our team. As a Senior Account Manager, you’ll support those connections by serving as a primary contact between clients and internal teams, ensuring clear communication, alignment, and client satisfaction. Working closely with the Director of Accounts and cross-functional team members, you’ll manage day-to-day communications, ensuring the strategic direction of the brand is aligned to projects and client needs are met. You will build, maintain, and grow relationships with clients, leading to organic growth. This is a client-facing role suited for someone organized, curious, and eager to lead in a purpose-driven creative environment. Job Responsibilities Business Management & Development • Manage the development of scopes of work and annual budgets for assigned account(s) in partnership with internal team, • Oversee estimates, billing, job closeouts, and financial tracking to support account profitability; ensure team compliance with Teamwork for accurate billing, • Identify organic growth opportunities by understanding client goals and making suggestions to supervisor and ultimately client, • Participate in internal brainstorms and planning sessions, contributing ideas and capturing action items aligned to client strategic objectives, • Build knowledge of brands, market, and business objectives; monitor market and competitive trends, • Participate in new business pitches as opportunities arise Client Relationship • Serve as day-to-day client contact for assigned clients, managing daily communication, setting expectations, and building trusted relationships, • Lead client meetings, tactical project discussions with strategic references, and status calls, ensuring clear documentation of decisions and action items; attend workshops and conferences, • Develop Project Briefs that align with client objectives, timelines, and budgets; provide clear direction and strategy to internal team members, • Review and approve creative deliverables before client presentation, ensuring strategic alignment, accuracy, and consistency with the Brief, • Lead tactical project execution, addressing client feedback and challenges with timely solutions; capture feedback, asking strategic questions to guide revisions and maintain project focus, • Operate within internal workflows and client processes throughout project lifecycle, • Set and manage client expectations regarding deliverables, timelines, and budgets Leadership & Collaboration • Foster and inspire a deeply collaborative atmosphere and culture, • Present work to clients for approval with cross-functional team members; solicit feedback on tactical execution, • Collaborate with cross-functional team members to deliver on Project Briefs, client expectations, and in accordance with brand guidelines, • Deliver work on time and in accordance with budgeted hours, • Work within agency systems and processes People Management What You Bring • 3+ years of pharmaceutical/biotech industry (in-house) or pharmaceutical/biotech agency experience managing branding-related projects across various mediums including but not limited to digital, print, environmental and events, • Ability to juggle multiple projects, meet deadlines, and stay solutions-focused, • Excellent written and verbal communication skills, • Experience presenting to clients, • Open, collaborative mindset—comfortable with feedback and iteration, • Detail oriented, organized, and proactive nature that anticipates client and internal team needs, challenges, solutions, • Proficient with Google Docs (including slide development) and agency workflow/project management systems, • Willingness to travel for client meetings or workshops as needed What We Value • A balance of task focus and people skills—able to collaborate with clients and colleagues alike, • Organized, resourceful, and proactive in managing multiple projects, • Exercises good judgment and knows when to ask questions or seek guidance, • Trustworthy and professional with sensitive information, • Driven, energetic, and committed to delivering high-quality work on time, • A genuine alignment with Second Melody’s mission and growth Hybrid Structure: While Second Melody’s offices are located in New Jersey, candidates are not required to reside in the state. However, they should be willing to travel to New Jersey for company events as needed. Benefits Time Off • Vacation - 12 days, • Personal - 12 days, • Sick - 5 days, • Medical insurance, Second Melody covers 75% of the employee's premium (available after 2 months of full-time employment), dependents can enroll at full premium, • Opportunity for promotion and internal career advancement available as necessary skills are developed and the company grows Salary Range: $85,000-$90,000

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.

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 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 Description Job Title: Warehouse Group Leader – Moonachie, NJ Company: Partners Personnel Location: Moonachie, NJ Job Type: Temp-to-Hire / Full-Time Schedule: Monday–Friday, 8:00 AM–4:30 PM Pay: $22/hour Job Description: Partners Personnel is seeking an experienced Warehouse Group Leader to oversee warehouse operations at our client’s Moonachie, NJ facility. The ideal candidate will manage warehouse staff, maintain accurate inventory and shipping processes, and ensure compliance with safety standards, GMPs, and FIFO procedures. Key Responsibilities: • Supervise warehouse personnel and assign daily tasks, • Manage inventory, receiving, and shipping operations, • Ensure proper handling, labeling, and storage of goods, • Maintain safety, cleanliness, and compliance with GMPs, • Use SAP and handheld scanners to track inventory, • 2+ years of warehouse experience, preferably in food, pharmaceutical, or nutraceutical industries, • Strong leadership and team management skills, • Forklift certification required, • Ability to lift up to 50 lbs regularly, • Strong English reading, writing, and communication skills, • Competitive pay: $22/hour, • Temp-to-Hire opportunity, • Monday–Friday schedule

Job Description About the Job Assist Chief Compliance Officer, North America (CCO), with the design, implementation, oversight, and enforcement of policies and practices to ensure corporate compliance with regulatory requirements relevant to pharmaceutical manufacturers in the United States and Canada. The Senior Manager, Compliance reports directly to the CCO. Job Responsibilities Note: These statements are not intended to be an exhaustive list of all responsibilities and duties. • Maintain all compliance files in an organized manner., • Serve as custodian of compliance files., • Provide administrative and other day-to-day support to CCO., • With input from CCO, maintain master tracker of ongoing work-flows, Corrective and Preventive Actions (CAPAs) and follow-up with appropriate individuals as needed., • Assist in drafting/reviewing/revising relevant compliance/business policies and standard operating procedures (SOPs), • Assist CCO in organizing, developing agenda and designing presentations for Compliance Committee Meetings., • Serve as Secretary at Compliance Committee Meetings., • Assist with auditing, monitoring and enforcement of Compliance efforts, including assisting with risk assessments, review of emails and other documents, etc., • Research, adopt and leverage innovative technology to identify and mitigate compliance risks, • Develop, assign, coordinate and track status of compliance-related training., • Follow-up with individuals who failed to attend trainings in a timely manner., • Coordinate and ensure exclusion and debarment checks are performed on a regular basis., • Track Compliance Department monthly spend., • Reconcile monthly spend with budget., • Assist CCO with compliance investigations and CAPAs. This may include maintaining notes, requesting and reviewing files, drafting reports, and participating in interviews., • Maintain understanding of laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical compliance and works with CCO to make updates to Compliance program as appropriate., • Gather information and conduct research relative to compliance issues., • Research and analyze statutes, regulations and other legal resources., • Work with cross-functional stakeholders to collect, analyze and submit required information and data for transparency reporting., • Ensure that training and updates are provided to members of relevant functions. Qualifications Education • Bachelor’s degree required, preferably in legal or accounting, • Prior pharmaceutical compliance experience required., • Strong moral compass and exhibits high standard of personal integrity., • Experience providing corporate training is preferred., • Experience in building and implementing key components of an effective compliance program, including written standards, training, auditing and monitoring and investigations, is preferred., • Must be organized and have a strong attention to detail., • Must be able to work well under pressure, meet short deadlines, and shift priorities seamlessly., • Must be able to work independently., • Must have a strong work ethic., • The incumbent typically works in an office environment and uses a computer, telephone and other office equipment as needed to perform duties., • The noise level in the work environment is typical of that of an office, • Incumbent may encounter frequent interruptions throughout the workday. Salary Range - $135,000 – 160,000 The compensation range provided reflects the expected base compensation only and does not include potential bonuses, incentive plans, or benefits. An individual’s final compensation offer will be based on a variety of factors, including but not limited to education level, relevant experience, training, and geographic location. Benefits include: • Paid time off, • 401k plus company match, • Company paid health benefits, • Dental, • Vision, • Onsite access to company gym, • Paid Employee Referral Program, • EAP – Employee Assistance Program, • Accident Insurance, • Critical Illness Insurance, • Short-Term Disability, • Life and AD & D Insurance, • Whole Life Insurance, • Pet Insurance and so much more! About the Company Glenmark is a global leader in the development and commercialization of generic drugs of the highest quality and value. We help to improve people’s lives every day by helping to reduce their healthcare costs while delivering high-quality medicines. Established in 2003 as a North American subsidiary of Glenmark Pharmaceuticals, we launched our first generic product in January 2005 and quickly emerged as one of the leading generic organizations in the United States. Today we have a diverse business. As a global leader in generics, we are leveraging our industry expertise and success to fuel extensive research to expand development in specialty branded products innovative products that are intended to have a major impact on how people live. This job description is to serve as a guide. It is intended to be flexible and will continue to evolve over time with business needs and demands and may be updated periodically and at the Company’s discretion. Nothing in this position description changes or is intended to change the employment at-will relationship with the Company. Employment at-will means that an employee or the Company may terminate the employment relationship at any time, for any reason or no reason at all, with or without notice. Glenmark Pharmaceuticals is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Job 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 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 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 Job Title : Regulatory Support Location: Basking Ridge NJ Remote Option: Yes. But the candidate should be available to attend customer meetings twice in a month Requirements Mandatory skills: -experience in pharmaceutical environment. -Experience in regulatory environment is required. -High level exposure or knowledge about FDA inspection and internal audit process. -Knowledge or exposure on Veeva RIM Submission/Archive, Publishing etc. Job Title: Consultant JD details : -Ensure compliance with company Standard Operating Procedures and regulatory agency regulations/guidance. -Represents Regulatory Affairs on cross-functional project teams. -Provide technical expertise to cross-functional teams on managing the lifecycle of submission-related documents. -Work with subject matter experts, and cross functional departments to support business needs. -Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance & validation. -Gather and assemble information necessary for submissions in accordance with regulations/guidance. -Capable of reviewing documentation with a high degree of attention to detail. Proactive to identify issues and propose solutions, as necessary. -Conduct review of published submissions to ensure consistency and compliance with regulatory requirements. -Maintain knowledge of local and global regulatory submission requirements. -Maintain compliance with GxP, government regulations, industry standards, approved specifications, and Company procedures &directives. -Provide Regulatory Affairs support during internal and external audits and inspections. -Exposure in Change management process, requirement gathering, qualifying the changes etc., -Actively participate in the development of Regulatory Operations processes like SOPs/GOPs, Work instructions, Checklist, templates etc. -Consistently support for regulatory systems access and change management. -Responsible for communicating business process improvements, business related issues, status updates or opportunities. Qualifications: -Bachelors’ degree, preferably in a life science or a related field -5 to 10 years of experience in pharmaceutical environment. -Experience in regulatory environment is required. -Excellent written, verbal communication and presentation skills. -High level exposure or knowledge about FDA inspection and internal audit process.

Job Description Mount Carmel Guild Behavioral Health System, a CARF accredited division of Catholic Charities of the Archdiocese of Newark, is a leading provider of mental health and addiction services in Northern New Jersey. We are currently seeking Full Time APN in for our Outpatient program in Union City, NJ. (Schedule described below). Our Outpatient Program uses a multi-disciplinary approach; emphasis is placed on individualized assessment, goal-oriented treatment planning, periodic case review, and continuity of care for all persons served. The program provides treatment and support to adults, children, and adolescents experiencing mental illness, behavioral, emotional or social problems. Enrollees are provided with means for developing and achieving short and long-term goals addressing their particular needs and circumstances necessary for effective functioning. Program components include: evaluation; treatment planning; individual and group counseling; couples and family counseling; skills training; advocacy services; case management; and medication management. Individuals ages 5 and up are treated. PREFERRED SCHEDULE: • Master's degree, • Current NJ APN License, • Current NJ Controlled Dangerous Substance Registration, • Current US DEA Controlled Substance Registration, • American Nurses Credentialing Center Certification, • Five years of experience with psychiatric clients as an RN/APN, • Three years inpatient-based experience as an RN/APN Visit our website CURRENT EMPLOYEES: Sh5aRrPnCg

Job DescriptionQuality Control Manager, Training & ComplianceAllendale, NJ The Quality Control (QC) Manager, Training and Compliance will manage the training and compliance programs across the analytical and microbiological laboratories. This role will ensure that there is a robust training program for the analytical and microbiological laboratories. In addition, this role will manage compliance activities within the laboratory such as deviations, CAPAs, document review, etc. The QC Manager will also be responsible for the management of external laboratories to include development of Quality Agreements, review of test results and resolution of any issues. • Develop and maintain training program within Quality Control which includes, onboarding and continuous training, • Manage deviations, CAPAs, change controls and document review to ensure compliance, • Ensure OOS investigations are completed adequately., • Manage external laboratories to include development of Quality Agreements, monitoring of samples and test results, reviewing deviations/OOS investigations, resolving issues and developing a scorecard to monitor the quality performance of the external laboratories, • Identify resources needed for training and compliance and build team accordingly, • Ensure compliance with applicable cGMP regulations while ensuring compliance with company and client requirements., • Monitor effectiveness of CAPAs, change control activities, and audit observation closure., • Directly supervises 1-4 employees within the Quality Control department(s).Directly supervised the following roles - Technical Trainers, Compliance Investigators, • Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. REQUIREMENTS, • BA/BS/MS in a science or relevant field required, • Prior cGMP experience required, • Prior QC laboratory experience in a cGMP environment a must, • 3-5 years’ experience in the pharmaceutical, biologics ore related industry, • Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of five (5) years in a management position, • Sound understanding of cGMPs, • Experience in laboratory training and compliance, • External laboratory management experience, • Strong knowledge of testing methodologies, philosophies, method validation and method transfers., • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review, • Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner, • Experience with laboratory training programs, • Knowledge of GMP requirements, • Excellent organizational and leadership skills, • Outstanding analytical problem-solving abilitiesWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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