- 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 ... plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs… more
- Baylor Scott & White Health (Boston, MA)
- …compartment) Hands:** Trigger fingers, Ganglions, Mallet fingers, Carpometacarpal ( CMC ) arthroplasty, , Dupuytren's (Palmar fascial fibromatosis), Amputations ... **Lower Extremity:** Hips:** Dislocation reductions, Total/partial Arthroplasty, Femoral fracture treatments, Arthroscopy Pelvis:** Fracture repairs Femur:** ORIF neck fractures, Trochanteric repairs, shaft fracture repairs Knees:** Dislocation… more
- Parexel (Boston, MA)
- …BSL2 (Biosafety Level 2) **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified ... and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their… more
- Parexel (Boston, MA)
- …standard operating procedures (SOPs) **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with ... qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet… more
- CBRE (Boston, MA)
- …external advisors + Borrowers and borrower counsel + CBRE producers, underwriters, and CMC groups **Ad Hoc & Strategic Projects** + Assist with training materials, ... team development, and executive leadership initiatives **What You'll Need** **Required Skills & Experience** **Expertise in executing Fannie Mae and Freddie Mac Structured Transactions including:** + **Fannie Mae Credit Facility & Bulk Delivery** + **Freddie… more
- AbbVie (Worcester, MA)
- …excellence. This is achieved through a focus on targeted product quality, CMC acceleration, people development, and efficient workflows. Key groups include: Cell ... line development, Cell culture process development, Purification process development, Scale-up lab, and Analytical development. Cell Line Development: Responsibilities include performing manual and automated processes to generate monoclonal cell lines and to… more
- Lilly (Boston, MA)
- …in the gas phase. + Prior experience in proteomics, bioanalysis, and/or CMC is a significant advantage. + Highly self-motivated and self-driven attitude with ... ability to own and drive projects into success. + Strong organizational and communication skills and effective people skills. + Capable of continuous learning, open-minded, highly organized, and detail oriented. + Ability to balance multiple activities,… more
- Sanofi Group (Waltham, MA)
- …in helping our teams accelerate progress. The Genomic Medicine Unit (GMU) CMC group at Sanofi is dedicated to the establishment of best-in-class manufacturing ... platforms to support development of life-changing advanced gene therapy products, including recombinant AAV vectors and non-viral LNP particles. Sanofi is looking for an experienced purification process development professional with experience in GMP… more
- EFI Global (Wilmington, MA)
- …+ Council-certified Indoor Environmental Consultant (CIEC) + Council-certified Microbial Consultant ( CMC ) + OSHA HAZWOPER. + Valid driver's license with clean ... driving history. **Experience** Five (5) years of related and practical experience in industrial hygiene or equivalent combination of education and experience required. **Skills & Knowledge** + Knowledge of general terms, conditions, nomenclature, etc.… more
- Takeda Pharmaceuticals (Boston, MA)
- …sub-teams, such as the Clinical Subteam, Commercial Subteam, Pharmaceutical Sciences ( CMC ) Subteam, etc. to the GPT through function-based subteam leaders to ... execute according to the Enterprise GPT Playbook, align and ensure transparency of all program-related activities. + Provides leadership and support to TAU/Franchise Leaders and Sub-team leaders to set the vision and direction for the Therapeutic Area Unit and… more