- Takeda Pharmaceuticals (Boston, MA)
- …good understanding of the drug development stages and strategy + Project management skills to oversee and coordinate various CMC activities + Working ... therapies to patients worldwide. Join Takeda as a Manager, Global Regulatory Affairs CMC Submission Management where you will support the execution of regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …to drive productivity and product quality improvement in Chemistry, Manufacturing & Control ( CMC ) processes; Employ technical project management principles ( ... Development Center Americas, Inc. is seeking an Associate Director, CMC Program Lead, Cell Therapies in Cambridge, MA with...briefing book packages and IND filings; Represent Cell Therapy CMC teams in technical, program, and governance forums and… more
- WuXi AppTec (Boston, MA)
- …**Technical Skills / Knowledge:** + Candidate should possess strong and effective project management , problem solving and interpersonal skills and have a ... CMC related business units and with the WuXi-TIDES management team to ensure coordination of all efforts and...Drug Product R&D and manufacturing. + Prior experience in project management or managing external research collaborations,… more
- Takeda Pharmaceuticals (Boston, MA)
- … CMC team AD representative or team lead). + Represent functional area on CMC project teams by communicating activities from designated functional area to ... theories, deliverables, and models for others to use. + Project management skills; ability to manage one's...Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing… more
- Sanofi Group (Cambridge, MA)
- …+ Familiarity with cGMP and regulatory requirements on analytical methods + Prior CMC project management experience + Excellent communications skills ... in CMC team meetings + Having a record of success in CMC project management + Having working knowledge of synthetic chemistry and pharmaceutical… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all project -related analytical control topics, development ... active pharmaceutical ingredients and drug products under cGMP's + Demonstrates effective project management skills + GMP and compliance experience required +… more
- Merck (Boston, MA)
- …discipline required. **Required Experience and Skills:** + At least 5 yearsof experience in project management + At least 5 years of experience in planning, ... skills to ensure alignment and collaboration in the supply planning process. + Project Management Skills: strong knowledge of the principles of project… more
- Merck (Boston, MA)
- …related discipline required, MS/MBA preferred. + At least 8 years of experience in project management . + At least 5 years of experience in planning, scheduling, ... skills to ensure alignment and collaboration in the supply planning process. + Project Management Skills: strong knowledge of the principles of project… more
- Takeda Pharmaceuticals (Boston, MA)
- …a vital contributor to our inspiring, bold mission. **OBJECTIVES:** Demonstrates excellence in project management in support of one or more drug development ... of development. Serves as a partner for the Global Project Leader in developing the asset strategy and ensuring...related functions (eg Clinical Science, Clinical Operations, Research, Regulatory, CMC , Marketing) + 3-5 years program management … more
- Sanofi Group (Waltham, MA)
- …assay and diagnostic development, qualification and validation + Demonstrated strong project management skills and multitasks under time pressure. Effective ... development, optimization and validation from research to life cycle management + Proven experience in CMC statistical...life cycle management + Proven experience in CMC statistical support for analytical methods development + Broad… more
- Sanofi Group (Cambridge, MA)
- …project strategy addressing essential aspects of product and process engineering, project management , quality (this includes establishment of a Design History ... and regulatory. You will partner directly with the Global Project Head, business, CMC key stakeholders, suppliers...FDA, EMA or TUEV + Experienced and qualified in project management activities (eg, PMP) preferred. +… more
- Sanofi Group (Framingham, MA)
- …in discovery, protein engineering, analytics, drug substance process development, and project management . **About you** + **Experience** : Management ... **Job title** : **Senior Scientist - CMC Biologics Drug Product Development and Manufacturing -...communication skills, and an established track record of cross-functional project management . Solid understanding of protein structure,… more
- Merck (Boston, MA)
- …, engineering or scientific discipline required. + At least 5 yearsof experience in project management + At least 5 years of experience in planning, scheduling, ... skills to ensure alignment and collaboration in the supply planning process. + Project Management Skills: strong knowledge of the principles of project… more
- Sanofi Group (Cambridge, MA)
- …settings and collaborate effectively in a multi-disciplinary team setting + Demonstrated project management skills + Consistent record of collaboration with ... group is part of the synthetic platform within Global CMC Development that is striving to become an industry...raw materials + Develop effective collaborations with others within project teams and between analytical groups + Generate technical… more
- Schrodinger (Cambridge, MA)
- …coach to internal partners + An excellent verbal and written communicator with robust project management skills + A goal-oriented team player who can bring ... the oversight of cross-functional teams, including members of our toxicology, bioanalytical, CMC , and clinical teams **What you will do:** + Overall GxP… more
- Sanofi Group (Cambridge, MA)
- …settings and collaborate effectively in a multi-disciplinary team environment + Demonstrated project management skills + Consistent record of collaboration with ... group is part of the synthetic platform within Global CMC Development that is striving to become an industry...analytical chemists within the group and other scientists in project teams + Introduce innovative analytical approaches to facilitate… more
- Organon & Co. (Boston, MA)
- …science, data science, clinical operations, regulatory affairs, chemistry, manufacturing and control ( CMC ), project management and other partner groups as ... development teams (ADT) across the portfolio including drug candidates and lifecycle management (LCM) for mature products or be TMED representative for a franchise.… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Passionate about developing others into future leaders **LICENSES/CERTIFICATIONS:** + Project Management Professional certification from PMI desired Takeda is ... into issues and develops contingency plans; communicates timely and proactively project -related issues to senior executive management and manages issues… more