- 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
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …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
- 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 (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
- Sanofi Group (Cambridge, MA)
- **Job Title:** Digital Product Owner (Director) In Silico CMC **Location:** Cambridge, MA, Framingham, MA or Morristown NJ **About the Job** At Sanofi, we're ... R&D problems sooner than ever before. Join our in-silico CMC Digital team as a Digital Product Owner and...as a product owner, product line owner or product manager + Experience in a healthcare company is a… more
- Adecco US, Inc. (Cambridge, MA)
- …dossier content. * Assists with reviewing contracts (such as CDSs, MSAs, Quality Agreements) and quotations to support CMC development projects, Industrial ... Healthcare & Life Sciences is hiring a contract Project Manager II for our Pharmaceutical partner in Cambridge, MA....pay upon meeting eligibility criteria. Description: Technical Leader, MSAT CMC Development The overall scope of this position is… more
- Fresenius Medical Center (Waltham, MA)
- The internal Job Title is called **Global Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products).** **Main Responsibilities:** + Support as regulatory ... regulatory requirements + Organization of submission-readiness of regulatory documentation (eg, CMC relevant parts) + Organize and support global creation and… more
- Sumitomo Pharma (Boston, MA)
- …clinical supplies on multiple clinical programs. In addition, working closely with CMC , Regulatory Affairs, Quality Assurance, Clinical Operations, and /or SMPA ... motivated, and experienced individual for the position of **Senior Manager , Clinical Supply Chain** . The Senior Manager...supply plans, and timelines in collaboration with Clinical and CMC . + Manage IP inventory levels at the depots… more
- Rhythm Pharmaceuticals (Boston, MA)
- …adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview The Quality Control Manager is responsible for oversight of testing performed ... have internal responsibility in stability monitoring, documentation best practices and quality control activities. This position reports into the Head, Analytical… more