- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team ... (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2, pre-NDA, Type… more
- Bristol-Myers Squibb Company (Indianapolis, IN)
- …to be the global leader in radiopharmaceuticals. Summary The Associate Director of Chemistry, Manufacturing & Controls ( CMC ) - Quality Assurance develops ... and drives Quality (manufacturing and analytical) strategies for CMC activities (drug substance, API, drug product, and analytics) for compounds in Development… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionGRACS CMC - Associate Principal Scientist, CMC , R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... / our Research & Development Division ) such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of portfolio, initiatives for… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... and packaging activities as well as supply chain documentation to support critical CMC activities. - - Support the collection of clinical supply chain metrics and/or… more
- Eisai, Inc (Exton, PA)
- …groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics ... If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building… more
- Merck & Co. (Rahway, NJ)
- …regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction ... and communication skillsPreferred Experience and SkillsExperience in leadership of CMC development teams.Experience with cell culture process development for… more
- Cedent (Cambridge, MA)
- …including strategy development, global submissions, agency meetings, and expedited designations; CMC experience is a plus. Experience in ophthalmology is an ... advantage. Project management experience is beneficial. Strong oral and written communication skills. Comprehensive understanding of global pharmaceutical development, including clinical and nonclinical activities. Department: Direct Clients This is a full… more
- EPM Scientific (Rockville, MD)
- …years of experience in biopharmaceutical process development, MSAT, or CMC roles. Extensive experience with commercial-scale cleaning validation and contamination ... control. Including ability to lead contamination control and cleaning validation programs. Proven expertise in large-scale stainless steel bioprocesses. Experience supporting DS manufacturing and cross-functional technical problem-solving. Must have biologics… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …employment application is true to the best of my knowledge. Job Description Associate Director , Clinical Research, Value & Evidence Generation, US Medical ... cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory, CMC or other drug development related function. Clinical Science experience… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you will oversee ... Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Plan, execute and manage regulatory… more
- WuXi AppTec (Boston, MA)
- …of 5 years of relevant pharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing. + Working knowledge and understanding of ... problems **Leadership Activities:** + Work closely with team members across all CMC -related business units and with the STA management team to ensure coordination… more
- BeOne Medicines (San Mateo, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics....the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD … more
- Boehringer Ingelheim (Ridgefield, CT)
- …We realize that our strength and competitive advantage lie with our people. The Associate Director , US Product CMC Regulatory Affairs is responsible for ... supplemental applications and post marketing reports per US FDA regulations. The Associate Director , US Product CMC Regulatory Affairs acts as primary… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and ... manages the scientific and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory authorities… more
- UTMB Health (Huntsville, TX)
- …skills. **_SUPERVISION:_** + Received: Associate Vice President Pharmacy Services, CMC + Given:Assistant Director , Pharmacy Staff **_BUDGET RESPONSIBILITY:_** ... Director Pharmacy Service - CMC Huntsville...working conditions for the pharmacy staff. + Assists the Associate Vice President of Pharmacy Services with strategic plan… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** The Associate Principal Scientist ( Associate Director ) is responsible for developing and implementing Regulatory ... Chemistry, Manufacturing & Controls ( CMC ) strategies for assigned small molecule and/or biological products...with global regulations and guidances, and Organon procedures. The Associate Principal Scientist will lead the preparation and submission… more
- UTMB Health (Brazoria, TX)
- Mental Health Clinician - CMC - Clemens **Brazoria, Texas, United States** **New** Social Service UTMB Health Requisition # 2503824 The mission of Correctional ... Works under the supervision of a Psychologist, Mental Health Manager and/or Program Director . **_ESSENTIAL JOB FUNCTIONS_** **:** + Contributes to the success of the… more
- Atlantic Health System (Pompton Plains, NJ)
- …medical laboratory technology/ medical or clinical laboratory science preferred + Associate 's degree in chemical, physical or biological science or medical ... all team members. Offerings vary based on role level (Team Member, Director , Executive). Below is a general summary, with role-specific enhancements highlighted:… more
- Merck (Upper Gwynedd, PA)
- **Job Description** GRACS CMC - Associate Principal Scientist, CMC , R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
