- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible for reviewing the CMC ... CMC content requirements based on internal technical documents provided by Technical Operations or from CMOs to support development program and life cycle… more
- Otsuka America Pharmaceutical Inc. (Boise, ID)
- **Job Summary** The Associate Director , Global Product Quality - Biologics is responsible for directing quality oversight of clinical and commercial products ... expectations and applicable cGMP/GDP quality standards. This role will direct Biologics Quality Assurance support, including oversight of upstream and downstream … more
- Lilly (Indianapolis, IN)
- …process control engineers and consultants that support the daily operations of the Biologics facility. The Associate Director is also responsible for the ... make life better for people around the world. The Associate Director -Automation Engineering is responsible for the...necessary systems and business processes required to support GMP operations , and build the site culture. This will require… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …deliver benefits for patients worldwide. Position Summary The Associate Director of Antibody Drug Conjugate (ADC) Manufacturing Operations is responsible ... We are LOTTE BIOLOGICS ! Delivering Therapies That Enable a Healthier...services to external customers and internal programs, and the Associate Director will play a critical role… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …innovation, to reliably deliver benefits for patients worldwide. Position Summary The Associate Director , Project Management Office (PMO) will play a key ... project lifecycle. The ideal candidate brings deep experience in biologics and CDMO operations , strong business acumen,...brings deep experience in biologics and CDMO operations , strong business acumen, and hands-on leadership in technical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** The QC Microbiology Director is vital role for the success of Clinical and Commercial ... Biologics and Small Molecule Quality Control. This individual provides...This individual provides strategic leadership and oversee daily microbiological operations . Responsibilities include leading the microbiology QC team supporting… more
- Mallinckrodt Pharmaceuticals (Horsham, PA)
- Job Title Associate Director , Manufacturing Operations Requisition JR000015470 Associate Director , Manufacturing Operations (Open) Location ... Horsham, PA Additional Locations Job Description Summary Job Description The Associate Director , Manufacturing Operations will provide leadership and… more
- Lilly (Lebanon, IN)
- …for clinical trial medicines, while also reducing costs and environmental impact. The Associate Director of Materials will lead the planning and procurement of ... direct materials supporting clinical supply manufacturing across small molecule, biologics , and peptides at the Lilly Medicine Foundry. This role ensures on-time… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Associate Director , Cleaning Validation is responsible for leading and executing Cleaning Validation (CV) activities for a large-scale ... biologics manufacturing facility in compliance with regulatory requirements, including...mitigate risks associated with the therapeutic product lifecycle. The Associate Director collaborates with cross-functional teams to… more
- Gilead Sciences, Inc. (Frederick, MD)
- …updates and changes. + Collaborate with cross-functional teams (eg, Quality, Regulatory, Operations , R&D) across a global network, to ensure document control needs ... PhD with 2+ years of related experience in a biologics or pharma organization OR + MS/MA with 8+...MS/MA with 8+ years of related experience in a biologics or pharma organization OR + BS/BA with 10+… more
- AbbVie (North Chicago, IL)
- …Waltham, MA Leads global regulatory dossier preparation activities for novel biologics by coordinating cross-functional teams of subject matter experts, from ... submission documentation for all phases of clinical development of biologics , with emphasis on later phase programs and marketing...various groups outside of DPD such as Process R&D Operations S&T, preclinical safety, PK, and QA. + Interface… more
- J&J Family of Companies (Horsham, PA)
- …Physicians, Research Scientists, Integrated Evidence Team (IET) Leaders, and Medical Affairs Operations members. The Associate Medical Director US Medical ... of America **Job Description:** We are searching for the best talent for Associate Medical Director , US Medical Affairs -Gastroenterology based in Horsham, PA.… more
- University of Southern California (Los Angeles, CA)
- …cell and gene therapies and other biological products for internal/external users. The Associate Director of Process Development (cGMP) is responsible for all ... aspects of operations related to the current Good Manufacturing Practices (cGMP)...Demonstrate: Master's degree in a scientific discipline (eg, pharmaceutical, biologics ). Four years of cellular or biological manufacturing experience… more
- Bristol Myers Squibb (Summit, NJ)
- …Control Operations and related functions. + Broad understanding of biologics or cell therapy commercial manufacturing & analytical processes, technology transfer ... and partners** + Cell Therapy functions (CT Development, CT Drug Product Operations , CT Quality, VExMO, CTTO, Supply Chain, Finance, Regulatory, etc.) + GPS… more
- Bristol Myers Squibb (Princeton, NJ)
- …lives. Read more: careers.bms.com/working-with-us . **Position Summary** Reporting to the Director , Inspection Readiness, the Associate Director will ... and collaborate extensively with teams and leaders across the BMS network. The Associate Director will support BMS' GMP/GDP Inspection Readiness strategy by… more
- United Therapeutics (Research Triangle Park, NC)
- …individual expertise and mentoring or developing a member of your team. The Associate Director , QA Engineering will provide advanced support and subject matter ... pharmaceutical operations (ie, aseptic filling, etc.), solid oral dose, biologics operations , medical devices, and combination products + Strong technical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …possible, together. **Job Description** We are seeking a dynamic and experienced ** Associate Director ** to join the **Global Supplier Quality** team within ... External Quality Operations . This leadership role will provide strategic direction and...categories (eg, single-use systems, resins, filters, media, excipients). The Associate Director will serve as a key… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** Associate Director , End-to-End Commercial Supply Planner plays a critical ... in developing and executing supply plans for commercial small molecule and biologics products. This role partners closely with regional commercial supply chain leads… more
- Bristol Myers Squibb (Bothell, WA)
- …first 60 days** **Reporting Relationship** This position reports to the Associate Director of Production Planning" **Qualifications** Education/Experience: + 0-3 ... related activities at the cell therapy manufacturing facility . Provides manufacturing operations with a plan that maximizes efficiency, resources, and capacity .… more
- Boehringer Ingelheim (Duluth, GA)
- …programs reflect Boehringer Ingelheim's high regard for our employees. The Senior Associate Director of US Regulatory Affairs Animal Health Intelligence and ... on a multinational basis with domestic and global trade associations. The Senior Associate Director of US Regulatory Affairs Animal Health Intelligence and… more
