- Merck & Co. (Rahway, NJ)
- …technical integration, assembly automation, etc.), as well as members of internal cross-functional product development teams from concept through product launch. The ... and regulatory aspects of combination products.The incumbent must be able to lead cross-functional development teams within DD&T and across our company, and work… more
- Merck & Co. (Durham, NC)
- …Our company in the United States and Canada, is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and animal health ... facility in Durham NC, the Supply Chain Logistics Strategy Leader will be responsible for the development, management, and...any new projects.- This includes SME support during routine internal and external GMP and Financial audits, QSAT actions,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …applicable Develops comprehensive, relevant resources (eg training program, FAQs) to enable compliance with quality control process requirements across NNI and ... role fulfills the PV Oversight function in PV quality control processes, as well as providing SME-level input from...drift in external vendor and NNI processes to mitigate non- compliance and deviation occurrence Support internal and… more
- Merck & Co. (Rahway, NJ)
- …and materialsEnsure a compliant, robust, and responsive supply chainIntroduce and lead strategic initiatives related to technical advancement, compliance , and ... within a regulated supply environment.Responsibilities include but are not limited to: Lead and oversee analytical investigations with a strong focus on quality and… more
- Merck & Co. (Millsboro, DE)
- …corporate and regulatory policies.Review production records for completeness and compliance to departmental and/or Site Standard Operating Procedures (SOPs).Provide ... projects with a high level of technical difficulties and internal constraintsScheduling and planning for department requirementsCoordinate with department personnel… more
- Merck & Co. (Rahway, NJ)
- …reputation through conference participation.Represent BPR&D as a upstream bioprocess expert/co- leader in internal and cross-functional project teams.Supervise, ... medical breakthroughs. We are looking for a collaborative, self-motivated -scientific leader with expertise in downstream bioprocessing to join Biologics Process… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Technical Lead , you will report into Director, Chemical Technical Operations, External Manufacturing API Technology, and play a pivotal role in ... mitigate risks, and continuously enhance performance.Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence.Serve… 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 ... industry. This leader will be responsible for managing the site quality...& Proteins.ResponsibilitiesThe Director, Quality will be responsible for:Maintaining site compliance to ISO 9001 for all aspects of the… more
- Natcast (Tempe, AZ)
- …excellence across our public-private partnership ecosystem. Every day you will evaluate internal controls , assess compliance requirements, and provide ... and execute risk-based audit programs Evaluate internal control effectiveness Assess federal grant compliance Review...years internal audit experience Strong knowledge of internal controls Federal grant audit experience Excellence… more
- Tris Pharma (Monmouth Junction, NJ)
- …in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/Regulatory Affairs, including reviews/approvals of Change Control ... (CCRs), methods, specifications, protocols and reports. She/he acts as MV lead for assigned projects regularly reporting status/issues to management, conducts… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... and productivity improvements.Support manufacturing investigations, support and manage change controls , and maintain permanent inspection readiness and actively support… more
- Formation Bio (New York, NY)
- …and more efficiently.About the PositionWe are seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing, and Controls (CMC) activities related to ... large molecule programs from early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a… more
- Twist BioScience (South San Francisco, CA)
- …experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom, ... align with 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)
- …Position Overview : Our Company is seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our ... establishing a strong business partnership and ensuring excellence in Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director,… more
- Merck & Co. (Rahway, NJ)
- …Downstream Purification-department is seeking a passionate and skilled individual to lead the charge in transforming our late-stage pipeline and commercial products ... reality.What You'll Do:As a key player in our BDSC team, you will: Lead and Collaborate: Participate in and/or spearhead cross-divisional technical teams focused on… more
- Merck & Co. (Rahway, NJ)
- …analytical control strategy development and execution. Demonstrated ability to lead a technical team and develop talent through good mentoring skills. ... the group Director to define group strategy and to lead a team of scientists in solving complex analytical...and experience with regulatory guidance and industrial standards of control strategy for residual HCPs and other process related… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to identify market trends, leading a high-performing team while ensuring compliance with legal standards. The Director will drive informed decision-making and ... Relationships Reports to the VP, Enterprise Insights. Has responsibility of cultivating internal and external relationships that bring value and insights to the… more
- Repligen (Rancho Dominguez, CA)
- …are seeking a highly motivated and experienced Senior Engineer to lead multi-product project execution, manufacturing support, and technology transfer efforts at ... a Subject Matter Expert for TFF and other bioprocessing manufacturing systems. Lead projects in equipment design, tech transfer, process validation, and facility… more
- Merck & Co. (Rahway, NJ)
- …primary program-level GCS point of contact representing the GCS Planning organization to customers both internal and external to GCS and serve s as the lead GCS ... Interacts closely with key partner organizations ( as a lead GCS Planning program representative ) such as clinical...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …(SM PR&D) organization. The SSO pilot plant enables gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing ... will provide hands on assistance for daily production activities while ensuring compliance with Safety & Environmental (S&E) and current Good Manufacturing Practices… more
