- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within ... based on the project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage project… more
- Tris Pharma (Monmouth Junction, NJ)
- Associate Director / Director , Analytical Research and DevelopmentMonmouth Junction, NJ Analytical Development, R&DDescriptionTris Pharma, Inc. ... in our Monmouth Junction, NJ headquarters has an immediate need for an experienced Associate Director / Director , Analytical Research & Development. Job… more
- Novo Nordisk Inc. (Boulder, CO)
- …are driving change. Are you ready to make a difference? The Position The Associate Director , Process Chemistry will be responsible for the design, development ... With a new laboratory completed in 2021 to support analytical and process development, the CMC team...scaling of small molecules, oligonucleotide intermediates and API's. The Associate Director is expected to implement novel… more
- Novo Nordisk Inc. (Boulder, CO)
- …with all applicable environmental, health and safety regulations. Relationships Reports to Associate Director , EHS at US headquarters in MA. Internal ... With a new laboratory completed in 2021 to support analytical and process development, the CMC team...to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** The Associate Director , Analytical Regulatory Science, collaborates with ... and quality teams on the construction, documentation and defense of the analytical control strategies in regulatory submissions preparation and review. By balancing … more
- Lilly (Philadelphia, PA)
- …determined to make life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global ... diagnostic radiopharmaceutical products. This includes the delivery of all relevant CMC regulatory submissions in addition to assessing country-specific CMC … more
- AbbVie (North Chicago, IL)
- …planning, preparation, review and approval of drug substance, drug product and analytical sections of CMC submission documentation. Develop and maintain ... is to ensure consistent preparation of drug substance, drug product and analytical sections of regulatory submission documents of high scientific and technical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall CMC strategies within ... based on the project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage project… more
- AbbVie (Florham Park, NJ)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: The Associate Director in CMC Statistics is responsible for providing ... areas with a focus on Chemistry, Manufacture and Control ( CMC ), expanding and broadening the application of Biostatistics. He/she...oral and written + Able to identify data or analytical issues, and assist with providing solutions by either… more
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager/ Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...and preclinical formulations + Lead the development of appropriate analytical test methods and stability studies for drug product… more
- Takeda Pharmaceuticals (Lexington, MA)
- …true to the best of my knowledge. **Job Description** **Objective / Purpose:** As an Associate Director in Analytical Development, it is expected that the ... Quality by Design (AQbD) + Experience in reviewing and approving analytical -related CMC sections of BLA/MAA regulatory submissions. Knowledgeable in European,… more
- Bristol Myers Squibb (Summit, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Title: Associate Director , Cell Therapy Comparability** **Location: Summit, NJ or ... your career, and the ability to help patients are incredible. The ** Associate Director , Cell Therapy Comparability** will lead comparability programs and… more
- Takeda Pharmaceuticals (Boston, MA)
- …review. As part of the Analytical Development team, you will report to Associate Director , Analytical Development. **How you will contribute:** + Develop ... a variety of method development, validation, and transfer; Ability to design and direct analytical strategy to meet CMC project objectives + Able to coordinate… more
- AbbVie (North Chicago, IL)
- …effectively managing local and global interfaces across Small Molecule and Biologics Analytical R&D functions (SMARD/BARD), CMC Regulatory Affairs (RA), Quality ... + Creates and implements short and mid-term GMP compliance strategies for the Analytical R&D (ARD) functions guided by global regulatory requirements, while… more
- University of Southern California (Los Angeles, CA)
- cGMP Associate Director Process DevelopmentApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/cGMP- ... products, in compliance with current Good Manufacturing Practices (cGMP). As the Associate Director of Process Development, the individual will be responsible… more
- Sanofi Group (Cambridge, MA)
- **Job Title: Associate Director Crystallization** **About the Job** We are an innovative global healthcare company with one purpose: to chase the miracles of ... work in a cutting-edge scientific global crystallization department in Sanofi's R&D CMC Synthetic organization. The job is in Cambridge MA, but close collaboration… more
- Frontier Medicines (Boston, MA)
- …scale-up challenges + In collaboration with the Development Project Lead and/or CMC Head, define timelines, production scale, and budget to support all development ... + .Work collaboratively with Quality Assurance and Regulatory to review analytical documents, stability results, manufacturing batch records and regulatory documents… more
- Schrodinger (Cambridge, MA)
- We are looking to hire a **Senior Manager/ Associate Director of Clinical Pharmacology** to join us in our mission to discover and develop drugs that improve ... drug development (MIDD) in drug development and dose optimization + An analytical mind who excel in data analysis, modeling, and simulation techniques to… more
- AbbVie (Waco, TX)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The ME&C Associate Director is a global program management expert responsible for ... have strong knowledge of GMP Manufacturing, Supply Chain, Validation, Engineering, CMC technical development and pharmaceutical regulations + *Must have demonstrated… more
- Gilead Sciences, Inc. (Foster City, CA)
- …more than 35 countries worldwide, with headquarters in Foster City, California. ** Associate Director - Material Science** **(Pivotal & Commercial Biologics)** ... & Manufacturing (PDM), Quality, Supply Chain, Manufacturing, Regulatory Affairs CMC , Finance, and Technical Development throughout all stages of biologics… more
