- 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
- 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
- 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
- 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
- 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
- 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. (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)
- …both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, the Program ... Familiarity with data analytics/visualization software . - Familiarity with Good Manufacturing Practices (GMP) requirements, quality procedures, and Standard… 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
- 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)
- …early and late-stage pipeline programs using fed-batch and continuous manufacturing platforms. The Director, Biologics Process Development (BPD) within the ... and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial launch. The… 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
- 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)
- …deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The ... and filings, Quality and our partners in the commercialization and manufacturing is essential.The successful candidate must function well and be able to… 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
- Merck & Co. (Rahway, NJ)
- …into insight and business decisions.Primary Activities:Interfaces with internal and external groups, gains consensus and contributes to reliable and effective ... data collection systems and other strategies that-optimize-statistical efficiency and quality .Develop and-maintain-Site Facility Energy Regression models.Work with Operations and… more
