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

Job Description 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.

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 Job Summary: Responsible for managing a company’s cash flow, banking activities, and related financial reporting. This is a hybrid position that requires two days in the Paramus, NJ office. Essential Duties and Responsibilities: • Monitor and report cash positions across multiple bank accounts and ensure adequate funding for operational needs., • Identify and report any unusual transactions or variances promptly., • Execute weekly payment runs, including vendor payments, ensuring accuracy, timeliness, and compliance with company policies., • Issue company checks., • Coordinate with accounts payable to validate payment schedules and resolve discrepancies., • Perform monthly bank reconciliations for all company bank accounts, identifying and resolving discrepancies efficiently., • Liaise with banking partners to address issues and streamline processes., • Maintain detailed records of payments for audit and reporting purposes., • Prepare and post journal entries for monthly financial closing, including payroll accruals., • Collaborate with the accounting team to ensure timely and accurate completion of treasury-related entries., • Validate accruals to ensure alignment with payroll data., • Corporate Income Tax Management/Liaison with Deloitte Tax Team., • Serve as the primary point of contact for Deloitte’s tax team regarding corporate income tax matters., • Compile and provide financial data, reports, and documentation to support tax filings and compliance., • Assist in coordinating tax planning, audits, and other tax-related activities, ensuring adherence to U.S. tax regulations., • American Express Company Account Management:, • Administer the American Express corporate card program, including card issuance, transaction monitoring., • Support cash flow forecasting and treasury reporting to aid in financial planning., • Assist in preparing documentation for financial audits and regulatory compliance., • Update and maintain treasury policies and procedures to align with internal controls and best practices., • Strong knowledge of cash management, bank reconciliation, and accrual accounting principles., • Experience with corporate income tax processes and working with external tax advisors is highly desirable., • Proficiency in financial software and ERP systems (e.g., SAP, Oracle, or similar); advanced Excel skills required., • Exceptional attention to detail and ability to manage multiple priorities under tight deadlines., • Strong communication and interpersonal skills to liaise with internal teams and external partners., • Bilingual in Japanese and English preferred., • Flexible and able to adopt to change., • Requires Bachelor’s Degree in related field with a minimum of 2-5 years of experience in treasury, accounting, or financial operations, preferably in a corporate or pharmaceutical setting., • Experience in the pharma industry preferred. 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 $70,000 to $85,000; 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.

Job DescriptionJob Title: Operations Manager Job Description We are looking for an experienced Operations Manager who can efficiently and effectively make operational and manufacturing decisions that impact the quality of our products. The ideal candidate will analyze and seek opportunities to improve resource capacity and track personnel process proficiency. You will ensure compliance with GMP and applicable regulations, and ensure staff adherence to corporate and site-specific HR, safety, and business policies. Additionally, you will lead shift handovers, maintain accurate process records, and resolve technical, procedural, and equipment issues promptly. Responsibilities • Make operational and manufacturing decisions impacting product quality., • Analyze opportunities to improve capacity availability and adherence to schedule metrics., • Ensure compliance with GMP, safety, and HR policies., • Alert and partner with EHS officers to resolve safety issues., • Lead shift handovers, assess schedule adherence, and provide status updates., • Maintain accurate process records including MBRs, work instructions, and logbooks., • Identify and resolve issues hindering production and compliance., • Assist in technology transfer to cGMP Manufacturing Operations., • Utilize Operational Excellence Principles to reduce process risks., • Perform cGMP and safety walk-throughs and assist with audits., • Coordinate with other departments for materials, testing, documentation, and scheduling., • Own and implement SOPs, BPRs, and other documentation., • Execute improvement projects and drive continuous improvement activities., • Design practices, processes, and procedures to meet customer expectations., • Partner with peer process owners to educate and communicate process performance., • Manage staff selection, training, evaluation, and development., • 5+ years of experience in a cGMP environment., • Experience in aseptic processing, mammalian cell culture, and cryopreservation., • 5-7 years of leadership experience., • Proficiency in pharmaceutical and GMP standards., • Experience with deviations, technical writing, and aseptic techniques., • Bachelor's degree., • Experience in sterilization and aseptic production. Work in an ISO clean room, managing 10-15 CGTAs. Initial shift is Sunday to Wednesday, 7am-5:30pm for the first 6-9 months. Afterward, the shift changes to Sunday to Wednesday night shift, 3:30pm-2am. Job Type & Location This is a Contract to Hire position based out of Allendale, New Jersey. This position is moving extremely fast as this is an urgent need for the client. If interested, please send over your most up to date resume to ktrivigno @astoncarter.com along with your availability for a 10-minute phone call. Pay and Benefits The pay range for this position is $62.00 - $65.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ. Application Deadline This position is anticipated to close on Sep 24, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Job DescriptionJob Title: Operations Manager Job Description We are looking for an experienced Operations Manager who can efficiently and effectively make operational and manufacturing decisions that impact the quality of our products. The ideal candidate will analyze and seek opportunities to improve resource capacity and track personnel process proficiency. You will ensure compliance with GMP and applicable regulations, and ensure staff adherence to corporate and site-specific HR, safety, and business policies. Additionally, you will lead shift handovers, maintain accurate process records, and resolve technical, procedural, and equipment issues promptly. Responsibilities • Make operational and manufacturing decisions impacting product quality., • Analyze opportunities to improve capacity availability and adherence to schedule metrics., • Ensure compliance with GMP, safety, and HR policies., • Alert and partner with EHS officers to resolve safety issues., • Lead shift handovers, assess schedule adherence, and provide status updates., • Maintain accurate process records including MBRs, work instructions, and logbooks., • Identify and resolve issues hindering production and compliance., • Assist in technology transfer to cGMP Manufacturing Operations., • Utilize Operational Excellence Principles to reduce process risks., • Perform cGMP and safety walk-throughs and assist with audits., • Coordinate with other departments for materials, testing, documentation, and scheduling., • Own and implement SOPs, BPRs, and other documentation., • Execute improvement projects and drive continuous improvement activities., • Design practices, processes, and procedures to meet customer expectations., • Partner with peer process owners to educate and communicate process performance., • Manage staff selection, training, evaluation, and development., • 5+ years of experience in a cGMP environment., • Experience in aseptic processing, mammalian cell culture, and cryopreservation., • 5-7 years of leadership experience., • Proficiency in pharmaceutical and GMP standards., • Experience with deviations, technical writing, and aseptic techniques., • Bachelor's degree., • Experience in sterilization and aseptic production. Work in an ISO clean room, managing 10-15 CGTAs. Initial shift is Sunday to Wednesday, 7am-5:30pm for the first 6-9 months. Afterward, the shift changes to Sunday to Wednesday night shift, 3:30pm-2am. Pay and Benefits The pay range for this position is $62.00 - $65.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ. Application Deadline This position is anticipated to close on Sep 24, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Job Description $10-15 million International Distributor. Up to 2 Days/Week Remote Work (maximum). If you are ready to step-up to lead an Accounting Department with full cycle responsibility this is the opportunity for you. Business majors with a minor in Accounting are encouraged to apply. Position Summary: Reporting to the Company President, the Accounting Manager is responsible for a US parent company and its European subsidiary in Netherlands. The Accounting Manager ensures accurate and timely financial reporting, credit management and regulatory compliance. Supervise two full-time employees at our US office and a part-time employee at our Netherlands office. Member of Company Management Team. About Us: We are a world leader in the field of pharmaceutical capsules and laboratory equipment. Our products are used by the pharmaceutical & nutritional industry worldwide to improve lives. Established in 1989 our steady growth has been based on superior products supported by superior customer service and technical support. Our headquarters are in Fairfield, NJ and we have a distribution center in Netherlands and a factory in India. Key Responsibilities: • Prepare monthly statements for each company individually and the consolidated group excluding inter-company sales. Provide information for month-end accounts review and year-end tax preparation to external accountants in Netherlands & USA., • Supervise Accounts Receivable including coordinating monthly accounts receivable review, setting customer credit limits., • Supervise Account Payable including control and review of purchase orders, vendor invoice approval and payment., • Ensure all corporate taxes (US federal, US state, Dutch and European VAT) and payroll are done on time., • Coordinate with Operations & Customer Service Managers to support overall company goals., • Coordinate with factory accounting team (separate company in India) inter-company sales, and monthly reconciliation. Audit Factory Invoices for direct and drop shipments., • Supervise submission of customer sales data to US Drug Enforcement Agency., • Supervise and ensure monthly inventory cycle counts are completed and reconciled., • Negotiate and coordinate renewal of insurance policies (cargo, products liability, health, etc.) and purchase of office equipment and services., • For Netherlands company fully implement Exact Online ERP software system. Skills: Strong skills in Excel, Word and Quickbooks or similar ERP. Strong analytical skills and attention to details. Excellent verbal and written communication skills. Personal Traits: Detail and systems oriented. Assumes “ownership” of accounting function. Thinks like a businessperson in addition to an accountant. Team player in supporting other functions in the goal of meeting customer needs Thrives in a small, quiet company environment. Eager to learn new aspects of the business. What’s in it for You · Member of Senior Management Team · Opportunity to be part of an internationally oriented, growing company offering the best products and service in their categories. · Competitive salary · Bonus Program · Health Club partial reimbursement · Company values program TrAnSScend. · Business casual dress code. If you would like to join our team, please email your cover letter and resume. We will contact you once we have reviewed your application to advise the next step in our hiring process. To learn more about our products visit and Company DescriptionWe are an extremely stable, internationally oriented company in the field of pharmaceutical capsules and laboratory equipment. Our products are used by the pharmaceutical & nutritional industry worldwide to improve lives. Established in 1989 our steady growth has been based on superior products supported by superior customer service and technical support. We have over $10+ million in sales and are consistently profitable. Our headquarters are in Fairfield, NJ and we have a distribution center in Netherlands and our own factory in Tarapur, India.We are an extremely stable, internationally oriented company in the field of pharmaceutical capsules and laboratory equipment. Our products are used by the pharmaceutical & nutritional industry worldwide to improve lives. Established in 1989 our steady growth has been based on superior products supported by superior customer service and technical support. We have over $10+ million in sales and are consistently profitable. Our headquarters are in Fairfield, NJ and we have a distribution center in Netherlands and our own factory in Tarapur, India.