- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Product Development will use their ... to ensure consistency and quality of team deliverables. A background leading Chemistry , Manufacturing, and Controls ( CMC ) aspects of drug/combination products on… more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Dossier Leadership will lead an ... experienced team responsible for the creation and management of high-quality CMC submission strategies and Module 3 regulatory documents. Reporting to the VP CMC … more
- Merck (North Wales, PA)
- …Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing and implementing Chemistry , Manufacturing, and ... Scientist is responsible for the leading the preparation and submission of CMC sections for commercial or new biologics products. The Principal Scientist will… 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; ... credibility. When appropriate leads meetings with Health Authorities under supervision of a senior member of the department. + Reviews CMC regulatory dossiers… 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
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** Reporting to the Director in Regulatory Chemistry , Manufacturing and Controls, the Senior Scientist is responsible for ... implementing Regulatory Chemistry , Manufacturing & Controls ( CMC ) strategies for assigned biological products in accordance with global regulations, guidance's… more
- Frontier Medicines (South San Francisco, CA)
- …Medicines is seeking a highly motivated individual for a newly created Director / Senior Director role in Process Chemistry in Frontier's South San ... molecule pipeline. The role will include oversight of CDMOs from process chemistry development through to drug substance manufacturing. Requirements What will you be… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory** **Science** **KEY** **RESPONSIBILITIES** ... The Sr Director , Analytical Regulatory Science, is responsible for supervising a...incumbent will support "right first time" global approvals for CMC control strategies and maintain "right to operate" throughout… more
- Lilly (Indianapolis, IN)
- …product, process validation, process controls, compliance, continuous process optimization, CMC regulatory support, manufacturing data analysis and process data ... management. The Sr. Director - TS/MS enables operational excellence by establishing strong...arise as part of routine manufacturing. + Collaborating with CMC to define, implement and improve control strategies for… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** Senior Technical Regulatory Advisor - Pharmaceuticals ( Senior /Executive Director ) OBJECTIVES/PURPOSE + To define and implement anexternal ... and trade associations and acts as an advisor/liaison to senior management to plan, evaluate and recommend CMC...SKILLS: + Bachelor'sor Advanced Degree in Life Sciences, Pharmacy, Chemistry , Biology or related discipline. + Languages: Fluent in… more
- Lilly (Indianapolis, IN)
- …the users' needs and intended uses. **Position Summary:** DDCS is seeking a Senior Director , Packaging Systems to lead, support, and manage container closure ... and delivery device pipeline portfolio. This individual must be versed in CMC development, materials evaluation, and packaging systems design and development to… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Scientist - Analytical Development (AD) Synthetic Molecules - Early Development where ... As part of the Analytical Development team, you will report to Director , Analytical Development. **How you will contribute:** + Develops project and technical… more
- Lilly (San Diego, CA)
- …an experienced toxicology leader for our Advanced Molecule Design (AMD) group. The Senior Director , Discovery Toxicology will be responsible for guiding early ... + Work closely with discovery leaders and teams (eg, DMPK, Chemistry , CMC , Pharmacology, PBPK modeling) to advise on and coordinate toxicology strategy,… more
- WuXi AppTec (San Francisco, CA)
- …responsible for leading the business development activities within STA, WuXi's CMC small molecule development and manufacturing division. The position works closely ... with STA's other BD team members and senior management team in China to develop and execute...are required. * BA/BS in Life Science (preferably in Chemistry related field), Business, Marketing or related Technical degree,… more
- BeiGene (San Mateo, CA)
- …vendor management team and escalate any quality or compliance issue timely to senior management when needed. + Closely collaborate with the CMO Vendor Management ... cross functionally and collaboratively in BeiGene with eg Manufacturing, Supply Chain, Regulatory CMC and other Quality teams like QPs in EU. + Provide quality… 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 (VDPD) team is ... environment with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure development of robust & scalable… more
- AbbVie (Irvine, CA)
- …Pharma Innovation Group at AbbVie seeks an accomplished scientist and leader. The Director / Senior Principal Research Scientist will lead a team performing in ... with bioinformatics SMEs and collaborating with partner functions in chemistry and/or biologics. The ideal candidate will have a...A key role for the position is partnering with senior management to conceive and provide strategic direction and… more
- University of Southern California (Los Angeles, CA)
- …characterization, final product release and comparability testing. + Creates Chemistry , Manufacturing, and Control ( CMC ) documentation for Investigational ... cGMP Associate Director Process DevelopmentApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/cGMP-Associate- Director -Process-Development\_REQ20129819/apply) Keck… more
- J&J Family of Companies (Malvern, PA)
- Johnson and Johnson is currently recruiting for a Senior Director - Head of Technology, Therapeutic Development and Supply within the Johnson & Johnson ... impact health for humanity. Learn more at https://www.jnj.com/. The Senior Director , Head of Technology - Therapeutic...to enable, accelerate and amplify the work of the CMC and Clinical Supply Engine to deliver the J&J… more
- Eurofins (Columbia, MO)
- …GMP product testing laboratories worldwide. Eurofins BPT provides comprehensive CMC laboratory services for the world's largest pharmaceutical and biopharmaceutical ... as technical leader within group and may be the project leader/study director on complicated projects. Responsibilities include: + Designs, carries out, and performs… more