- Actalent (North Billerica, MA)
- …activities, assess risks, and develop strategic plans. Essential Skills + Experience with CMC , tech transfer, validation, and quality assurance. + Proficiency in ... Job Title: Quality Specialist for Site Qualification and Stability StudiesJob...studies. The role involves technical transfer, reviewing and authoring CMC documents, site auditing, and maintaining submission information in… more
- Actalent (North Billerica, MA)
- Quality Assurance and CMC Specialist Responsibilities + Qualify new sites and assist with stability studies. + Support technical transfer processes. + Review, ... author, and assist with CMC documents. + Conduct site audits and contribute to...activities, assess risks, and develop strategic plans. + Ensure quality assurance and compliance with GMP standards, including change… more
- Lilly (Philadelphia, PA)
- …to make life better for people around the world. Responsibilities: The Associate / Manager , CMC Regulatory and IMP Manufacturing Operations is a hybrid role ... Development supporting the two functional areas. The Associate / Manager is responsible for CMC regulatory operations,...as well as task management to ensure compliance with quality management systems + CMC regulatory operations… more
- Gilead Sciences, Inc. (Foster City, CA)
- …help create possible, together. **Job Description** **Responsibilities** + The Regulatory Affairs CMC Senior Manager at Gilead is responsible for providing ... strategic direction, tactical support, and technical expertise for CMC regulatory activities and related regulatory initiatives. + Responsible for guiding and… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …through nextGen portals is a plus. + Interact with manufacturing and quality groups, partner organizations, regarding CMC issues. + Independently manage ... relationships with other local and/or global functional units [OPCJ CMC RA, Factory, Quality , MPDD, OPDC/OPEL Tech Ops] as well as affiliates, external… more
- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Early-Stage Biologics Development, CMC Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage ... for patients suffering from immunological diseases. Position Summary: The Senior Manager , Early-stage Biologics Development, CMC will be responsible for… more
- Lilly (Philadelphia, PA)
- …CMC Regulatory is responsible for the preparation and delivery of high- quality CMC regulatory submissions. This position supports Lilly/Avid diagnostic ... Responsible for the generation and execution of country specific CMC regulatory strategies + Author and review global ...CMC regulatory strategies + Author and review global CMC dossiers + Coordinate and contribute to responses to… more
- Orchard Therapeutics (Boston, MA)
- … development strategy. . Support the planning, preparation and submission of high- quality Regulatory CMC content for submissions, such as meeting materials, ... the Regulatory Team provide Regulatory and Chemistry, Manufacturing and Control ( CMC ) related expertise for development and commercial stage products, including… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Regulatory Affairs Manager **Location:** Swiftwater, PA, Morristown, NJ **About the Job** Are you ready to shape the future of medicine? The race is ... in helping our teams accelerate progress. The Chemistry, Manufacturing and Controls ( CMC ) regulatory team is accountable for the global regulatory strategy for… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Digital Product Owner (Associate Director/Senior Manager ) In Silico CMC **Location:** Cambridge, MA, Framingham, MA or Morristown NJ **About the ... us get new medicines to patients faster and more efficiently. As an Associate Director/Senior Manager Product Owner for in silico CMC , you will join a dynamic… more