- Arthrex (Naples, FL)
- …and Responsibilities: Work closely with Biologics Product Marketing Management, Product Management and Product Director to develop and manage ... a monthly review of progress and updates for the Product Director and PM team. Meet regularly...and/or clinical experience. OR two years as an Arthrex Associate Product Marketing Manager OR two years… more
- Merck (Rahway, NJ)
- …as the biopharmaceutics support for the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the ... identify key biopharmaceutics risks at each stage of drug product development for small molecules and/or biologics ,...The Director will report to the Executive Director of Biologics and Biopharmaceutics, have 8-10… more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Biologics DPD, is responsible for overseeing ... compounds from LO to FIH as well as advancing biologics drug product research initiatives. This individual...FIH as well as advancing biologics drug product research initiatives. This individual has multi-disciplinary scientific expertise,… more
- Merck (West Point, PA)
- **Job Description** **Position Description:** ** Associate Director , Quality Systems & Compliance** Our Quality Assurance group ensures every single material ... on time, every time, across the globe. **Position Responsibilities:** + The Associate Director is responsible for performing comprehensive and detailed GMP… 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
- 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for ... topics. **Responsibilities** - Supports CMC regulatory compliance activities for portfolio biologics to meet US, International Conference on Harmonization (ICH), and… more
- Charles River Laboratories (Memphis, TN)
- …technology transfer principles and guidance. + Provides functional leadership of product transfer from the process establishment stage to commercial Good ... + Leading the Memphis MSAT team responsible for all aspects of product transfer from the process establishment stage to commercial Good manufacturing Practices… more
- Merck (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR) The Associate Director is responsible for the review and approval of all US ... promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of study results in US… more
- Merck (West Point, PA)
- …Our Company is seeking a highly motivated candidate for the position of Director , Vaccine Drug Product Development. Vaccine Drug Product Development ... The Director will report to the Executive Director of Vaccine Drug Product Development, have...be responsible for a team of 10-20 senior and associate level scientists. The incumbent will be responsible for… more
- Takeda Pharmaceuticals (Columbus, OH)
- …to the best of my knowledge. **Job Description** **About the role:** ** Associate Director , Nonclinical Regulatory Writing and Submission Support,** **_Oncology ... you will be a vital contributor to our inspiring, bold mission. As an Associate Director in the Nonclinical Regulatory Writing and Systems (NRWS) Department… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director - Site Planning Global Process Leader (GPL) ... planning processes and digital capabilities are delivering the needs of the Biologics and Pharmaceutical commercial business units . **Key Responsibilities** Forge a… more
- Bristol Myers Squibb (Devens, MA)
- …lives. Read more: careers.bms.com/working-with-us . **PURPOSE AND SCOPE OF POSITION:** The Associate Director , CTF Digital Plant IT Quality at Devens Cell ... and Q9) particularly as it applies to Cell & Gene Therapy or Biologics manufacturing. + Demonstrated knowledge of Quality principles and QA methodologies including… more
- Axtria, Inc. (Berkeley Heights, NJ)
- …minds in the industry. Description: We are looking for Senior Manager and Associate Director for our Decision Science practice. Success in this position ... the Life Sciences industry. We help Life Sciences companies transform the product commercialization journey to drive sales growth and improve patient healthcare… more
- BeiGene (Hopewell, NJ)
- …+ Ensure timely generation of certificates of analyses (COA) for raw materials, product intermediates, DS and DP in support of manufacturing operations. + Manage the ... analytical capability for large molecule products to further support company's biologics business. + Ensure laboratory equipment and system qualification, validation… more
- Merck (West Point, PA)
- …+ Ensure that Area objectives are achieved while reliably supplying quality product at a competitive cost consistent with our Company, Regulatory Agency, and ... innovative mindset and ability to implement innovative solutions + Experience in biologics , vaccine, or bulk sterile manufacturing facilities + In accordance with… 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 ... Assurance (QA), CMC Coordination, Product Development Science and Technology (PDS&T), among others. + Develops and aligns in close cooperation with stakeholders… more
- AbbVie (North Chicago, IL)
- …Brand Manager(s) or similar cross functional group(s), to support Brand or product initiatives including product analysis and project management. Understands and ... working relationships within these groups. Identifies and executes opportunities for product , process, and/or culture improvement within or outside of Supply Chain.… more
- University of Maryland, Baltimore (Baltimore, MD)
- …agency site visits. This program covers all major areas of drug product and biologics regulatory science, including: Chemistry, Manufacturing, and Controls ... of Pharmaceutical Sciences with teaching responsibility to the Graduate Program Director and Associate Dean for Graduate Programs. *_ACADEMIC RESPONSBILITIES… more
- Novo Nordisk (Princeton, NJ)
- …The Position Manage and oversee all assigned projects/products/processes. Assist the Director / Associate Director in assuring Novo Nordisk compliance ... regulatory agencies. Supervise designated personnel. Relationships Report to the Director / Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory… more
