- 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
- Sanofi Group (Waltham, MA)
- **Job Title:** CMC Project Manager **Location:** Framingham, MA, Waltham, MA **About the Job** Are you ready to shape the future of medicine? The race is on to ... be critical in helping our teams accelerate progress. The CMC Project Manager is a key contributor...for critical batches, in close coordination with Analytical and Quality representative. + Ensure the execution, integration and coordination… 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
- WuXi AppTec (Boston, MA)
- …WuXi STA. WuXi TIDES offers our worldwide partners efficient, flexible, and high- quality solutions for the drug development of oligonucleotides, peptides and related ... drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development, and the entire manufacturing supply chain under one roof. **Please… 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
- 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
- WuXi AppTec (Boston, MA)
- **Overview** **Senior Manager Project Management, TIDES Discovery** **Area of focus: Discovery or medicinal chemistry** **Job Location: Remote USA with 10% travel ... WuXi STA. WuXi TIDES offers our worldwide partners efficient, flexible, and high- quality solutions for the drug development of oligonucleotides, peptides and related… more
- RTX Corporation (Marlborough, MA)
- …studies, Transition To Production (TTP) planning and Advanced Product Quality Planning (APQP) implementation. + Report on Program Contract On-Time ... Delivery (OTD) Performance for both CMC and non- CMC products. + Support Gate 11 activities at close of Development/EDM /Production contracts. + Travel will be… more
- Shuvel Digital (Boston, MA)
- …budget. Performs analysis for contract reviews with various software. Develops Quality Assurance Programs for all products and services. Prepare Staffing Plans, ... and monitoring multiple interdependent projects, ensuring timely delivery and quality outcomes. + Experience tracking progress, performance metrics, and program… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory ... and guidelines. - Confirms submission documents are accurate, compliant, and high- quality to allow for smooth and expeditious approvals from regulatory authorities.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …manage individual study budgets and communicates status to appropriate TA project manager ; and execute communication and change management plans. + Represents and ... regular reporting (eg, key product dashboards, financial aspects) are delivered with high quality and partner with TA Project Managers as necessary. + Oversees &… more
- Sanofi Group (Framingham, MA)
- …Technology) organization and interface functions and organizations, such as Development/ CMC (chemistry, manufacturing, and controls), Quality , Manufacturing, ... impact on the lives of countless people worldwide. As_ **_Scientist VIE_** _in our CMC Development team you will collaborate with other scientists in the team and… more
- Takeda Pharmaceuticals (Boston, MA)
- …support, keeping in mind value maximization and strong sense of the time/ quality balance. + Provides matrix management, strategic and tactical leadership to GPT ... on the sub-team objectives. + Accountable with the responsible Global Program Manager for activities operating budgets within the global program; leads budget… more
- Takeda Pharmaceuticals (Boston, MA)
- …support, keeping in mind value maximization and strong sense of the time/ quality balance. + Provides matrix management, strategic and tactical leadership to GPT ... the GPL on the sub-team objectives. + Accountable with the Global Program Manager for operating budgets within the global program; leads budget setting in… more