- Merck (North Wales, PA)
- **Job Description** Under general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing ... and implementing Chemistry, Manufacturing, and Controls ( CMC ) regulatory strategies for our organization's biologics product franchises in accordance with domestic… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of...areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall … more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The EACD department develops new CMC paradigms for more effective and efficient NCE development and for advancement of NCE-like Alternative Medicinal ... Therapeutic Product (ATMP) projects. The Associate Director , Analytical/QC will be responsible for leading activities related to Analytical Development/Quality… more
- BeiGene (San Mateo, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical ... while identifying risk and developing mitigation plans by working with supply chain leaders and CMC project managers. + Act as point of escalation if… more
- Editas Medicine (Cambridge, MA)
- …and distribution of non-GMP materials at all locations. Key Responsibilities: As the Sr. Director , Supply Chain, you will be responsible for: + Building out all ... This role will partner with Clinical Operations to secure clinical supply needs and with Commercial, CMC , Engineering and PD for commercial supply chain… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Years and Counting!** Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Years and Counting!** Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... and Oncology, incl. coordinating Reg Intelligence & Policy activities with the Regulatory- CMC function and corporate affairs as needed. In the short term, the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead and help create possible, together. **Job Description** **Key Responsibilities:** Senior Director , Global External Manufacturing, Biologics will lead an ... organization to ensure uninterrupted supply of Gilead's clinical and commercial biologic products through...A proven capability to contribute to the success of CMC functions as a senior leader +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …direct impact. Join Gilead and help create possible, together. **Job Description** The Senior Director of Materials Science will spearhead the technical support ... members in Gilead Pharmaceutical Development & Manufacturing (PDM), including Quality, Supply Chain, Manufacturing, Regulatory Affairs CMC , Finance and Technical… more
- Organon & Co. (Jersey City, NJ)
- …Reporting to the Director in Regulatory Chemistry, Manufacturing & Controls ( CMC ), the Senior Scientist is responsible for implementing Regulatory Chemistry, ... Manufacturing & Controls ( CMC ) strategies for assigned products in accordance with global...with global regulations, guidance's, and defined regulatory strategies. The Senior Scientist is responsible for the preparation and review… more
- Sumitomo Pharma (Columbus, OH)
- …management of the global contract testing laboratories in partnership with the Company's CMC Team. The Associate Director also participates in drafting and ... **Associate Director , GMP Quality Control** Sumitomo Pharma America (SMPA)...internal stakeholders and external partners to ensure released drug supply within expiry date is available to support commercial… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. ** Director , Strategic Sourcing and Supplier Management, Biologics DP** **KEY RESPONSIBILITIES** ... The Director , Strategic Sourcing & Supplier Management, Biologics DP owns...point of contact for strategic business discussions, long range supply and/capacity planning, and business development + Management of… more
- J&J Family of Companies (Lexington, MA)
- …is part of the global Drug Delivery Systems (DDS) team. The position reports to the Senior Director , Head of DDS located in Malvern, PA (US). Leads and oversees ... Engineering Director , Devices - 2406181206W **Description** Johnson & Johnson...analytical development teams within the TDS Therapeutic Development & Supply (TDS) organization. Partner closely with the broader DDS… more
- Gilead Sciences, Inc. (Foster City, CA)
- …countries worldwide, with headquarters in Foster City, California. **Associate Director , Strategic Sourcing and Supplier Management, Primary Packaging Components** ... **KEY RESPONSIBILITIES** The Associate Director , Strategic Sourcing & Supplier Management, Primary Packaging owns the business relationships with direct material… more
- Merck (Columbus, OH)
- …topics owners across the company globally to align change control, batch disposition and regulatory/ CMC process in an effort to accelerate supply to patients. + ... of data. The Change Control Business Architect - Associate Director (AD) will ensure that change control capabilities meet...change control landscape and to provide oversight to less senior team members, as needed. **Education:** + Minimum of… more
- Hubbell Power Systems (Greenville, AL)
- …US, 36037-2435 Company: Hubbell Incorporated Job Overview The Plant Manager for CMC Greenville, AL, is responsible for overseeing the daily operations of ... DOH, budgets, OTDP, etc.) + Reports solid-line to the Director of Operations but may receive assignments from other... of Operations but may receive assignments from other senior corporate team members. + Ensure all activities meet… more