- Merck & Co. (North Wales, PA)
- Job DescriptionUnder 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. (Bernards, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... well as other research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within… more
- Merck & Co. (Rahway, NJ)
- …in one or more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or Analytical Research is critical for understanding ... Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product , Analytical Development, and Clinical Supply across all modalities. We are… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Project Team (GPT) for these plans, ensuring appropriateness throughout the product 's lifecycle and across different indications. Represent Global Regulatory Affairs ... and/or arbitrator on global projects.Interface with clinical and pre-clinical groups, Regulatory CMC and other appropriate groups within the company as needed. In… more
- Novo Nordisk Inc. (Boulder, CO)
- …seeking a highly experienced and dynamic professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Manager ... The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its...is accountable for clinical phase 1 and 2 drug product manufacturing and will have thorough knowledge of cGMP's… more
- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Product Development will use their breadth of ... leadership on key pipeline projects while also supervising and mentoring a team of CMC Product Development Directors. A key function of the role is to serve as a… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA CMC Pharmaceuticals Development Portfolio Lead where ... trade associations and acts as an advisor/ liaison to senior management to plan, evaluate and recommend implementation strategy....CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs -… more
- 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… more
- J&J Family of Companies (Horsham, PA)
- Johnson & Johnson is recruiting for an Associate Director , CMC Regulatory Affairs. This position can be located in Spring House, PA; Horsham, PA; Titusville, NJ; ... Provides regulatory and technical expertise and input to the CMC team to facilitate successful product development...leads meetings with Health Authorities under supervision of a senior member of the department. + Reviews CMC… more
- Takeda Pharmaceuticals (Lexington, MA)
- …development plans. As part of the GRA CMC team, you will report to the Senior Director GRA CMC and work cross functionally across the business. **How you ... life-changing therapies to patients worldwide. Join Takeda as a Director GRA CMC where you will independently...registration and/or pos-approval strategies for assigned products as GRA CMC Product Lead. Represents and contributes to… more
- Lilly (Indianapolis, IN)
- …The Associate Director , CMC Project Management may also partner with the Senior Director or Assoc. VP, CMC Project Management to deliver high ... for people around the world. **Position Summary:** The Associate Director , CMC Project Management will provide strategic...the program and project management arm of our critical Product Research and Development group. CMC Project… more
- Takeda Pharmaceuticals (Boston, MA)
- …part of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + ... life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you... CMC experience including experience as an RA CMC product lead with late stage development,… 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 ... as other research areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall CMC strategies within… more
- Lilly (Philadelphia, PA)
- …This position has overall responsibility for Avid's global investigational medicinal product (IMP) manufacturing, IMP and commercial product precursor and ... cost targets. + Collaborate with cross-functional team leaders, including development, CMC regulatory, manufacturing, and supply chain teams, to ensure seamless… more
- Vera Therapeutics (Brisbane, CA)
- …experienced, fast-paced and collaborative team. The Senior Manager will report to the Senior Director of Regulatory CMC and will be responsible for ... Job Title: Senior Manager, Regulatory CMC Location: Brisbane,...change the standard of care for patients. Vera's lead product candidate is atacicept, a fully humanized fusion protein… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory** **Science** **KEY** **RESPONSIBILITIES** ... for CMC control strategies and maintain "right to operate" throughout the product lifecycle. In addition, the Sr Director will be accountable for leading… more
- Lilly (Indianapolis, IN)
- …following the approved control strategy, and maintaining validated status during the product cycle. + Collaborating with CMC on early-stage clinical ... third party contract manufacturers) for the manufacture of finished drug product , process validation, process controls, compliance, continuous process optimization, … more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. Purpose: The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to ... + Lead Global Regulatory Team consisting of regional regulatory scientists, GRA- CMC , GRA-Devices, GRA-RD&E, and GRA-Global Labeling and Product Communications.… more
- BeiGene (San Mateo, CA)
- …quality standards. The role has global responsibility and accountability for commercial product quality for global supply. The job holder leads and develops a ... staff of Quality professionals to ensure the product quality from CMOs as well as closely work...and escalate any quality or compliance issue timely to senior management when needed. + Closely collaborate with the… more
