- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- … regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating ... and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized… more
- Merck (Wilson, NC)
- …(Research & Development, Commercialization, Tech Ops, Ops, Quality, Analytical Regulatory - CMC , and Supply Chain, etc.) **Minimum Education Requirements ... other TT teams. + Required to comply with our Company Global and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance… more
- Cambrex High Point (Minneapolis, MN)
- …understanding of the industrial regulatory landscape; Good understanding of site SOPS, regulatory + CMC concerns and can answer client questions and help ... cross-functional technical departments, including organic chemistry and engineering. + GMP/ Regulatory Knowledge: Strong understanding of the GMP landscape and… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …effectively with local Technical Services, site leadership, Pharmaceutical Sciences, Global Quality, Regulatory CMC , and other key functions to align on ... will be at the interface of development, manufacturing, and regulatory , shaping robust, scalable processes and ensuring they are...of drug product and packaging processes in line with regulatory and Takeda standards. + Act as part of… more
- Genentech (Hillsboro, OR)
- …a track record of successfully leading Process Performance Qualification (PPQ) and authoring CMC sections for regulatory filings. + You thrive in "startup" style ... clinical development to commercial-scale manufacturing, ensuring phase-appropriate validation and regulatory compliance. + Architect Process Design & Scale-up: Spearhead… more
- AbbVie (North Chicago, IL)
- …medicines. In the course of our work, we collaborate with early-stage CMC , Quality Assurance, Regulatory Affairs, Internal and External Manufacturing, and ... discipline. + Effective writer and communicator of research or other regulatory materials. Additional Information Applicable only to applicants applying to a… more
- Amgen (Boulder, CO)
- …with domestic and international CMOs/CROs + Solid understanding of cGMP, Regulatory / CMC , legal, quality requirements, and import/export policies + Self-starter ... with a high-level of comfort with ambiguity and complexity and the ability to multitask while consistently delivering quality results + Experienced team member of cross-functional and matrixed teams including effective writing, presentation, and interpersonal… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and review technical documents, development reports, SOPs, manufacturing batch records, and CMC sections of regulatory submissions (IND, INDa, BLA). + Transfer ... downstream processes to manufacturing sites, CMOs, and partner sites, ensuring successful scale-up and implementation. + Represent Downstream Process Development on cross-functional teams and contribute to strategic initiatives. + Produce significant… more
- Fujifilm (Holly Springs, NC)
- …Application (BLA) sections + Prior authorship of Chemistry, Manufacturing and Control ( CMC ) sections for regulatory findings **WORKING CONDITIONS & PHYSICAL ... REQUIREMENTS** + Ability to discern audible cues _To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …Teva Standard Operating Procedures + Partners cross-functionally with departments such as Regulatory Affairs, CMC , Biostatistics, GCO, in the execution of ... Lead, Clinical Scientist. and other functional areas such as GCO, biostats, regulatory , pharmacovigilance. The Director will be a key contributor to INDs, NDAs,… more