- Merck & Co. (Rahway, NJ)
- …ensuring the reliable supply of quality products at competitive costs from external manufacturing partners (EPs) and to integrating these EP into our ... support the enterprise and division's strategic priorities.Our company's Small Molecule External Manufacturing organization is responsible for management of… more
- Merck & Co. (Durham, NC)
- …Position Overview : Our Company is seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our ... between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong business… 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)
- OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology ... analysis, customer complaint management, hosting customer/regulatory audits and Certificate of Quality generation at an ISO 9001:2015 certified manufacturing … more
- Merck & Co. (Millsboro, DE)
- …Management, Life Cycle Logistics, Mammalian Cell Culture, Management Process, Manufacturing Quality Control, Operational Excellence, Packaging Operations, People ... global manufacturing network that's committed to delivering a high quality , reliable supply to customers and patients on time, every time.Our Company's… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Oversee cell therapy production and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization ... operations ramp-up of commercial and clinical capacity.Build strong partnerships with Manufacturing , Supply Chain, Engineering, MS&T, and Quality to ensure… more
- Twist BioScience (South San Francisco, CA)
- …South San Francisco)Job DescriptionWe are seeking an experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic ... our overall manufacturing strategy and business objectives. The Director will lead a team of MES professionals, primarily software developers, who work in… more
- Merck & Co. (Durham, NC)
- …and an inspiring mission to achieve new milestones in global healthcare. Our Manufacturing Division is a team of dedicated, energetic individuals committed to being ... pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, form an interdependent global … more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... development of formulation, manufacturing process, and primary packaging to enable phase appropriate.../ our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound… more
- Merck & Co. (Rahway, NJ)
- …standards (eg, FDA, cGMP), maintain optimal environmental conditions for product quality , and support continuous operations. The ideal candidate will have strong ... strategies that ensure compliance with GxP (as applicable) and other regulatory requirements. Lead the operation of the site BAS and HVAC control systems. Manage… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Engineer will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and ... Biotech is seeking MES Engineer as part of the Manufacturing Excellence team based in Raritan, NJ. Role OverviewThe...Global Procedures.Act as a Site MES SME to support Quality Investigations, Corrections, and QMS records.Build the Site Readiness… more
- Formation Bio (New York, NY)
- …Collaboration & External Partnerships Partner closely with analytical development, manufacturing , quality , and regulatory teams to ensure seamless execution ... the PositionWe are seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing , and Controls (CMC)...Establish and manage key relationships with CDMOs and other external partners to support development and manufacturing … more
- Merck & Co. (Rahway, NJ)
- …& Manufacturing , in a fast-paced, multidisciplinary environmentParticipate in or lead 1) development of robust and scalable upstream processes for biologics in ... on tight timelines, in a rapidly changing environmentExperience and aptitude to lead , work, and collaborate in internal and external cross-functional, matrixed… more
- Repligen (Clifton Park, NY)
- …Lead all operations at the site, including Planning, Procurement, Manufacturing , Distribution, Engineering, Quality and Customer Service Order Processing.Hire ... and is responsible for site related functions, including all of Operations and Manufacturing roles at the site. The successful candidate will play a key role… more
- Merck & Co. (Rahway, NJ)
- …surveillance.This position will interact with cross-functional development teams within and external to Device Development. The incumbent must be able to work ... ResponsibilitiesLead/contribute to device development, design controls for the assigned projects. Lead the implementation and/or ensure effective execution of the… more
- Merck & Co. (Rahway, NJ)
- …data models, and BI artifacts to ensure collaboration and code quality .Experience leveraging Databricks for big data processing, advanced analytics, or machine ... to integrate data solutionsStrong Influencing and negotiation skillsAbility to lead , create future state, and deliver resultsDemonstrated ability to develop… more
- Tris Pharma (Monmouth Junction, NJ)
- …according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs) procedures. The incumbent prepares, coordinates and advances ... required documentations, in liaison with Product Development (PD)/ Quality Assurance (QA)/ Quality Control (QC)/Regulatory Affairs, including reviews/approvals of… more
- Merck & Co. (North Wales, PA)
- …clinical/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring ... Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of trial conduct.Providing tactical/scientific mentorship… more
- Merck & Co. (Rahway, NJ)
- …with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems at the interface of ... established reputation for scientific excellence supported by publications and external presentations is expected.Qualifications -Education:Ph.D. in analytical chemistry/biochemistry or… more
- Eisai, Inc (Exton, PA)
- … Quality Control, Validation, and other internal (PST) and external functions to support successful product development, including sharing expertise, ensuring ... Pilot Plant as well as supporting technology transfer to external partners (as required). The Associate Director sets strategic...with other Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC… more
