- Lilly (Indianapolis, IN)
- …for people around the world. **Job Summary** The Director /Senior Director , CMC , Drug Product Development will lead formulation development ... (CROs, CDMOs) with capabilities in drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) related to drug… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …provides subject matter expertise for all aspects of Drug Substance (API), Drug Product , and Combination/Device product development against the applicable ... **Overview** The Director , CMC provides leadership for the...questions. + Supports the preparation and management of complex CMC development plans including long-range planning. +… more
- Taiho Oncology (Princeton, NJ)
- …Value Proposition: Join our dynamic and expanding mid-size company in the role of Director for Regulatory CMC directly reporting to Executive Director , ... Taiho Oncology Inc., (TOI) projects; provides strategic regulatory guidance especially for CMC during drug development , approval and post approval processes and… more
- Astellas Pharma (Northbrook, IL)
- …regulatory activities in collaboration with local and global stakeholders (eg, Product Development & Manufacturing, Regulatory Affairs, Quality Assurance, ... strategies for internal teams. **Cross-Functional Collaboration:** + Partner with Product Development & Manufacturing, Quality Assurance and Regulatory… more
- Boehringer Ingelheim (Duluth, GA)
- …Boehringer Ingelheim's high regard for our employees. The Director , Scientific Expert CMC is responsible for providing new product and marketed product ... extensive experience and a high level of technical competency, ensuring that product development objectives are achieved efficiently, compliantly, and in… more
- AbbVie (Florham Park, NJ)
- …& Development (R&D) organizations. Represents CMC on teams such as product development , Global Regulatory Product Teams and Operations brand teams to ... requests. + Represents CMC regulatory affairs on teams such as the product development , Global Regulatory Product Teams and Operations brand teams,… more
- Amgen (Washington, DC)
- …to CMC data, spanning drug substance, drug product , and delivery device development . As Director , CMC Modeling & Advanced Statistics, you will: + ... CMC development and commercial support. Reporting to the Senior Director , CMC Statistics, you will drive innovation in kinetic modeling, Bayesian… more
- BeOne Medicines (San Mateo, CA)
- …consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory ... CMC regulatory issues and mitigation activities needed throughout product life cycle. Escalate the critical issues to senior...to senior management timely. + Lead or contribute to development of internal small molecule CMC regulatory… more
- AbbVie (North Chicago, IL)
- …a matrix management approach. + Serve as the primary Drug Product Development (DPD) representative to interface with the CMC Regulatory group. Develop ... the clinical/regulatory development strategy and provides drug development experience and advice to the CMC ...drug development experience and advice to the CMC team. Influences development of new regulatory… more
- Sanofi Group (Framingham, MA)
- …possible for millions. The Associate Director role is a key leadership role in CMC Biologics Drug Product Development and Manufacturing. You will be part ... **Job Title:** Associate Director - CMC BioDPDM **Location** : Framingham, MA...multiple modalities. The ideal candidate will possess strong drug product formulation and process development experience. This… more
- Regeneron Pharmaceuticals (Troy, NY)
- …, or Program Management with direct experience in ADC, siRNA, or mRNA product development and successful launches, or equivalent combination of education and ... conjugates, peptides). Responsible for end-to-end operational coordination-linking Manufacturing, R&D, CMC , clinical, regulatory-to enable accelerated development and… more
- Teva Pharmaceuticals (West Chester, PA)
- CMC Biologics Quality Control Director , Physiochemical Testing Date: Nov 15, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... and manage departmental strategies for physiochemical testing with respect to product in-process, release and stability testing, raw materials testing, contract lab… more
- Organon & Co. (Jersey City, NJ)
- …Primary responsibilities include, but are not limited to: **Responsibilities** + Serve as the CMC Product Lead for assigned products and be accountable for the ... **Job Description** **The Position ** Reporting to the Director in Organon Regulatory CMC , the...of all regulatory milestones for assigned products through the product lifecycle. + Lead development and execution… more
- Atlantic Health System (Pompton Plains, NJ)
- …or hemolyzed blood according to approved procedures + Monitors blood and blood product inventory to ensure adequate supply for patient transfusion, orders blood and ... cost. This commitment is also echoed in the respect, development and opportunities we give to our more than...members. Offerings vary based on role level (Team Member, Director , Executive). Below is a general summary, with role-specific… more
- Lilly (Indianapolis, IN)
- …world. We are looking for a highly qualified statistical leader who will lead the product development statistics team in supporting a wide variety of projects in ... the product development (nonclinical) area of LRL in...novel methods and strategies to enable or advance drug development and manufacturing + Author/review sections of CMC… more
- Gilead Sciences, Inc. (Foster City, CA)
- …late-phase portfolio. + Support the design/justification/execution of end-to-end control strategy development through a proactive definition of the product ... & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development … more
- Lilly (Indianapolis, IN)
- …Regulatory, CMC PM) and external CDMOs to align and execute the CMC development plan. + Create and update end-to-end capacity models, provide important ... around the world. **Overview:** We are seeking a Senior Director , ADC Process Development , to lead and...IND/IMPD/BLA submissions and regulatory interactions. + Deep understanding of CMC workflow, process development and scale-up, tech… more
- AbbVie (Irvine, CA)
- … programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge ... by program needs, in partnership with Discovery, Translational, and CMC colleagues contribute to design and implement translational strategies....OD, MD, PharmD) preferred. *At least 8 years of product development experience with 5 years of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and early clinical phases. + CMC awareness: Understanding of drug substance/ product development and manufacturing timelines. + Possess strong business acumen ... the broader Pharmaceutical Development and Manufacturing (PDM) organization, the **Senior Director , Product Management Team Lead** will lead a team of … more
- Lilly (Indianapolis, IN)
- … cycle (proof of concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is expected + ... purification, isolation, and formulation. The position presents an opportunity to lead CMC activities to support clinical trials, product commercialization, and… more
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