- Teva Pharmaceuticals (Parsippany, NJ)
- …manufacturing, packaging, technology transfer, cGMPs, EU, ICH guidelines as well as CMC content of regulatory submissions, + Deep knowledge of ... Senior Director , Site Quality Head, Goa Date: Sep 5,...to ensure a mature culture of quality, compliance with regulatory requirements and quality of products. This oversight includes… more
- Lilly (Indianapolis, IN)
- …global regulatory climate and emerging requirements. Ability to address key CMC regulatory questions that enable clinical studies and support marketing ... optimization of synthetic drug candidates to support clinical trials, regulatory submission, and product commercialization. The position presents an opportunity… more
- Merck (Rahway, NJ)
- **Job Description** The Associate Director , Engineering, Packaging Commercialization will lead packaging development for new products including parenteral products ... dosage. This role involves collaborating with stakeholders across the end-to-end continuum of CMC areas and requires both an understanding of packaging as well as… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Location: Cambridge, MA** **About the role:** As a Process Scientist (Associate Director ) - Global Manufacturing Science GMSci Drug Product (DP), you will provide ... and the life cycle management of existing products. You will lead regulatory interactions, including the preparation of Chemistry, Manufacturing, and Controls (… more
- BeOne Medicines (Emeryville, CA)
- …collaborate and build strategic relationships with internal (Clinical Operations, Quality, CMC , Regulatory , etc.) stakeholders. + Demonstrates advanced knowledge ... The Director of Comparator Purchasing, Clinical Supply Chain is...functionality and Excel modeling. + Understands comprehensive global pharmaceutical regulatory requirements (eg cGMP, ICH/GDP, GCP, 21 CFR Part… more
- Lilly (Indianapolis, IN)
- …to support communities through philanthropy and volunteerism **Position Summary:** The Senior Director of TSMS - Tech Transfer is a strategic leadership role within ... technical excellence, and fosters collaboration across development, manufacturing, and regulatory functions. **Key Responsibilities:** **Tech Transfer Leadership** + Lead… more
- Boehringer Ingelheim (Ridgefield, CT)
- …a seasoned legal professional to join our Legal Department as Executive Director & Executive Counsel - Intellectual Property. This role provides strategic legal ... counsel to senior leadership (VP, EVP, CMC , and Level 1 executives), with a focus on...decisions by providing strategic IP input into clinical and regulatory activities, including assessing potential third-party IP risks. +… more
- Bristol Myers Squibb (Seattle, WA)
- …for: + Technology transfer and process validation across the product lifecycle + CMC lifecycle management and regulatory strategy + Oversight and governance of ... harmonization, and standardization to ensure global manufacturing scale-up, reliability, and regulatory compliance We are seeking a strong strategic technical leader… more
- AbbVie (Irvine, CA)
- …required by program needs, in partnership with Discovery, Translational, and CMC colleagues contribute to design and implement translational strategies. May ... strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues.… more
- Bristol Myers Squibb (Devens, MA)
- …biological products and will be the lead technical representative to global regulatory agencies for these products. **Key Responsibilities** - Develop and execute ... the MS&T strategy aligned with organizational goals and regulatory requirements. Oversee cross-functional initiatives to drive innovation, process optimization, and… more