- Aequor (Thousand Oaks, CA)
- …alongside other innovative, driven professionals in this meaningful role. Role: Specialist Manufacturing , New Product Introduction Let's do this! At we strive ... the introduction of new products into the manufacturing plant. This "Specialist Manufacturing " role will serve as a New Product Introduction Lead within the… more
- Merck & Co. (Durham, NC)
- …Compliance:-Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product ... (8) years of experience in Biopharmaceutical industry across multiple manufacturing disciplines (Operations, Quality , Technology, Engineering, Supply Chain,… more
- Merck & Co. (Rahway, NJ)
- … quality compliance, which will include following current Good Manufacturing Practices (cGMPs), and participating in risk assessments, deviation investigations, ... Chemical Commercialization Technology (CCT) department, which is part of our Manufacturing Division , is seeking self-motivated individuals who are looking for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis Senior Engineer position will provide engineering support to the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, primarily ... and Original Equipment Manufacturers (OEM) and vendors.Provide engineering and quality engineering (QE) support, ensuring facility, utilities and equipment are… more
- Merck & Co. (Rahway, NJ)
- …(FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply ... in Rahway, New Jersey.The Sterile Process Engineer role at the Senior Specialist level will leverage the individual's leadership, technical, and communication… more
- Merck & Co. (Rahway, NJ)
- …and Development (BAR&D), Bioprocess research and development (BPR&D), and Sterile Product Development & Commercialization (SDPC, our Manufacturing Division) in ... and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …planning activities and PAS-X/SAP related projects. He/she will work with Planners, Manufacturing , Facilities, Quality Control, MSAT, and Engineering to support ... Novo Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia...a global supply of our hemophilia and growth hormone product lines, as well as our next generation of… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing , and Controls ... Collaboration & External Partnerships Partner closely with analytical development, manufacturing , quality , and regulatory teams to ensure seamless… more
- ACROBiosystems Inc. (New York, NY)
- ACROBiosystems is a worldwide leader in developing and manufacturing recombinant proteins and critical reagents/assays to support drug development and clinical ... and companion diagnostics. We are committed to excellence in providing quality products and services and accelerating the process of therapeutic development.… more
- Merck & Co. (North Wales, PA)
- …methodologies and tools to enable the discovery, development, regulatory approval, manufacturing , and marketing of medical drugs and vaccines for the benefit ... in ensuring that project plans are executed efficiently with timely and high quality deliverables. - For assigned projects the position serves as the statistical… more
- Merck & Co. (Rahway, NJ)
- …to set tactical and strategic direction on programs to ensure delivery of high- quality products, test methods, and robust manufacturing processes for both ... extensive knowledge in medical device engineering, particularly in the design, manufacturing , verification, validation and associated quality and regulatory… more
- Repligen (Waltham, MA)
- …analysis, customer complaint management, hosting customer/regulatory audits and Certificate of Quality generation at an ISO 9001:2015 certified manufacturing ... the quality team responsible for complaint handling for the Waltham manufacturing site.Develop, Monitor and Compile Quality metrics as inputs for monthly… more
- Merck & Co. (Rahway, NJ)
- …with site leadership to drive preparedness for agile and efficient multi- product manufacturing operations.Establish and lead a cross-functional launch readiness ... Process Performance Qualifications (PPQs), Pre-Approval Inspections (PAIs), and best-in-class multi- product launch manufacturing .To achieve this, this highly… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these ... operations ramp-up of commercial and clinical capacity.Build strong partnerships with Manufacturing , Supply Chain, Engineering, MS&T, and Quality to ensure… more
- Merck & Co. (Rahway, NJ)
- …( s ) . - Responsible and accountable for establishing the timelines for bulk manufacturing needs and release of drug product across assigned program(s) . - ... Familiarity with data analytics/visualization software . - Familiarity with Good Manufacturing Practices (GMP) requirements, quality procedures, and Standard… more
- Merck & Co. (Rahway, NJ)
- …development related meetings (i .e., Clinical Trial Team s ) and product development related meetings . The incumbent must have demonstrated understanding of ... E2E product development process & connectivity between functions supporting pipeline...with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical… more
- Merck & Co. (Rahway, NJ)
- …position will be responsible for leading and implementing medical device and combination product design controls for both new products and inline products from early ... design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact with… more
- Merck & Co. (Rahway, NJ)
- …clinical site. The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie ... health), and balancing needs of patients & ensuring stable supply of product .Primary activities include, but are not limited to:-Participates on the Clinical Trial… more
- Aequor (Thousand Oaks, CA)
- …Chain processes, systems, and procedures. Interfaces across functions including Supply Chain, Manufacturing , Finance, Regulatory, and Quality at various level of ... begin EOD Weds 7/23 Standard business hours Supply Chain Senior Manager - Global Supply Chain Leader What you...and will be accountable to deliver strong and agile product leadership through the orchestration of end-to-end global Supply… more
- Repligen (Clifton Park, NY)
- …Operations leadership team. Communicate effectively both internally and externally.Focus on delivering quality product to our customers based on our commitments. ... matrixed roles.Lead all operations at the site, including Planning, Procurement, Manufacturing , Distribution, Engineering, Quality and Customer Service Order… more
