- Orchard Therapeutics (Boston, MA)
- …business priorities. This role represents a unique opportunity to contribute to Regulatory CMC activities supporting maintenance and development of Orchard's ... products in clinical development: . Participate in definition and implementation of Regulatory CMC strategy for assigned program(s). . Collaborate with Technical… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned ... drug manufacturing processes, GMP and related issues. + Knowledge of CMC regulatory requirements for biologics and small molecules during development and… more
- Fresenius Medical Center (Waltham, MA)
- …to comply with regulatory requirements + Organization of submission-readiness of regulatory documentation (eg, CMC relevant parts) + Organize and support ... The internal Job Title is called **Global Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products).** **Main Responsibilities:** + Support as … more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Adecco US, Inc. (Cambridge, MA)
- Adecco Healthcare & Life Sciences is hiring a contract Project Manager II for our Pharmaceutical partner in Cambridge, MA. The anticipated hourly wage for this ... law; and Holiday pay upon meeting eligibility criteria. Description: Technical Leader, MSAT CMC Development The overall scope of this position is to manage CMC… more
- Takeda Pharmaceuticals (Boston, MA)
- …integral part of the Pharmaceutical Sciences Sustainability and Technology (PSST) Sustainable CMC & Innovation team within PharmSci, In Silico First Program and ... Strategy Manager is crucial to operational efficiency & technical direction...and driving new operational methodologies, while adhering to evolving regulatory compliance requirements. Moreover, this role establishes key metrics… more
- Rhythm Pharmaceuticals (Boston, MA)
- …review, and approval of standard procedures. + Author and review regulatory CMC submissions including analytical procedures, method validations, reference ... our tenacity to overcome barriers, together. Opportunity Overview The Quality Control Manager is responsible for oversight of testing performed at Rhythm's contract… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical ... with significant experience within related functions (eg, Medical Affairs, Clinical Operations, Regulatory , CMC , Marketing). + Minimum of 5 years' experience as… more
- Sanofi Group (Framingham, MA)
- …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 ... technologies, and study plans independently and with guidance from the direct manager and other subject matter experts (SMEs). + Collaborate with other scientists… more
- HCA Healthcare (Manchester, NH)
- …and processes, initiates changes and improvements, and makes suggestions to Manager + Demonstrates knowledge and ensures compliance with all current policies, ... procedures and regulatory standards (TJC, OSHA, EEOC and others) within all...and health care financial metrics. Preferred Catholic Medical Center ( CMC ) (https://catholicmc.com/) is an acute-care hospital owned by HCA… more
- Takeda Pharmaceuticals (Boston, MA)
- …versatile and strong enterprise leaders + be committed to simultaneously driving regulatory approval as well as product launch and global patient access + ... 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
- Takeda Pharmaceuticals (Boston, MA)
- …experienced, versatile and strong enterprise leaders + Committed to simultaneously driving regulatory approval as well as launch and global patient access + Ability ... on the sub-team objectives. + Accountable with the responsible Global Program Manager for activities operating budgets within the global program; leads budget… more