- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionGRACS CMC - Associate Principal Scientist, CMC , R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr ... include, but are not limited to:Regulatory Responsibilities: Serve as a CMC Product Lead for assigned products and be accountable for the delivery of… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop ... / our Research & Development Division ) such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of portfolio, initiatives for… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, the ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Eisai, Inc (Exton, PA)
- …groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics ... your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and...III and PV at CMOs at the company's discretion.5. Lead and assist in troubleshooting upstream and downstream process,… more
- Merck & Co. (Rahway, NJ)
- …regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction ... tight timelines, in a rapidly changing environment.Experience and aptitude to lead , work, and collaborate in internal and external cross-functional, matrixed… more
- Seaport Therapeutics (Boston, MA)
- …We are seeking a strategic, hands-on Associate Director OR Director , Regulatory Affairs to lead regulatory project teams and submission activities across ... strategy for CNS therapies. (For Director level) 7+ years (For Associate Director level) Relevant hands-on experience leading IND/CTA and/or NDA/MAA… more
- BioSpace (Cambridge, MA)
- Job Details The Role Moderna is seeking a Associate Director Publication Writer to lead end-to-end publication management activities across multiple ... external authors, as well as cross-functional teams including Medical, Research, Development, CMC , Health Outcomes, and external vendors, to lead writing… more
- City of Montebello, CA (Montebello, CA)
- …other City staff; performs related duties as required. DISTINGUISHING CHARACTERISTICS: The Director of City Clerk Services is an executive level classification in ... operations consistent with applicable laws, City policies, and administrative guidelines. The Director of City Clerk Services is distinguished from the elected City… more
- Olema Oncology (San Francisco, CA)
- …feel better, longer. For more information, visit us at www.olema.com. About the Role Associate Director , GMP Quality Assurance As the Associate Director ... company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine...our CMOs and distribution networks as well as internal CMC and Clinical Supply Chain groups. You will also… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you will oversee ... CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you...ability to liaise with Regulatory Agencies, having served as lead in successful Agency Interactions related to CMC… more
- BeOne Medicines (San Mateo, CA)
- …and process optimizations on relevant topics. **Essential Functions of the job:** + Lead , develop and implement small molecule CMC regulatory strategies as well ... CMC regulatory strategies for the assigned projects. + Lead regulatory risk assessment, identify key CMC ...+ Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities needed throughout product… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and ... changes in the external environment. + Utilizes scientific and regulatory knowledge to lead preparation, review, and finalization of CMC documents for global… more
- Organon & Co. (Plymouth Meeting, PA)
- …regulations and guidances, and Organon procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for programs in ... **Job Description** **The Position** The Associate Principal Scientist ( Associate Director...are not limited to: **Responsibilities** + Serve as the CMC Product Lead or support the … more
- WuXi AppTec (Boston, MA)
- …the US and requires English and Mandarin language skills. **Responsibilities** + Lead all project initiation and planning efforts. Participate in the implementation ... of 5 years of relevant pharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing. + Working knowledge and understanding of… more
- Merck (Upper Gwynedd, PA)
- **Job Description** GRACS CMC - Associate Principal Scientist, CMC , R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal ... include, but are not limited to: **Regulatory Responsibilities:** + Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all… more
- Takeda Pharmaceuticals (Boston, MA)
- …for the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Associate Director , Regulatory Data Governance Lead **POSITION ... DESCRIPTION** : Takeda Development Center Americas, Inc. is seeking an Associate Director , Regulatory Data Governance Lead with the following duties: Oversee… more
- BeOne Medicines (Emeryville, CA)
- **_General Description:_** Sr. Manager/ Associate Director , Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the ... goals. He/she will also work with functions within the company to support and/or lead new product introduction, new market launches as necessary. This role will be… more
- Takeda Pharmaceuticals (Lexington, MA)
- …application is true to the best of my knowledge. **Job Description** ** Associate Director , Clinical Research, Value & Evidence Generation, US Medical** ... objectives include: + Partners with Head of US Medical Clinical Science Lead to translate strategy into efficiently executable research plan; predicting and planning… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Drug Substance Commercial Development **Location** : Cambridge, MA **About the Job** Are you ready to shape the future of ... progress. The Commercial Process Development team, part of the CMC Synthetics Platform within the Sanofi R&D organization, is...join our growing Commercial Process Development team as an Associate Director . Under the direction of the… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Health and a Brighter Future to people worldwide. As an Associate Director in Analytical Development, you will lead efforts to develop advanced analytical ... separation-based techniques (eg, U/HPLC, CE-SDS, icIEF, glycan profiling, etc), you will lead a team to ensure analytical methods and strategies meet scientific,… more
