- 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
- 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 (Athens, 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
- Takeda Pharmaceuticals (Boston, MA)
- … investigational, registration and/or post-approval strategies for assigned products as GRA CMC Product Lead. + Represents and contributes to Regulatory, ... executes and oversees regulatory submissions preparation per the GRA CMC Product Team CMC strategy....be considered. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development … more
- BeOne Medicines (Emeryville, 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
- 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
- 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
- Bristol Myers Squibb (Madison, NJ)
- …requirements. T he individual will provide technical expertise and leadership to Product CMC /Quality Teams to develop, implement, and manage the strategies ... Expertise in GMP compliance, global regulations and strong understanding of pharmaceutical product development lifecycle are required. + Experience with review… 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
- 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
- J&J Family of Companies (Spring House, PA)
- …analytics, AI/ML (incl. GenAI); manage portfolio prioritization, funding, and value realization. + CMC , Product & Process Development : Enable scientists and ... scientific discovery and clinical application, encompassing Chemistry, Manufacturing & Controls ( CMC ), Device Development , and Clinical Supply Chain. This… more
- Gilead Sciences, Inc. (Washington, DC)
- …for combination products and devices. . **Global Regulatory Excellence** Lead the development of global CMC regulatory initiatives focused on combination ... scientific degree with directly relevant professional experience in small molecule and biologics development , global CMC regulatory affairs and CMC technical… more
- Sumitomo Pharma (Lincoln, NE)
- …FDA and ICH regulations/guidance documents specific to clinical research and general product development in the pharmaceutical industry + Experience reviewing ... with a minimum of 4 years focused in regulatory affairs + Oncology product development experience preferred + Experience contributing to electronic regulatory… more
- Lilly (Indianapolis, IN)
- …Design and Development (SMDD) need for drug substance and drug product development , characterization, and supply of material for toxicology and clinical ... new medicines that will help solve our world's greatest health challenges. In Product Research and Development (PRD), we transform molecules into medicines. Our… more
- Amgen (Thousand Oaks, CA)
- …peptide, and/or oligonucleotide development and commercial lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and ... transform the lives of patients while transforming your career. ** Product Quality Director - Synthetics** **What you...annual product review) in support of the Product Development Team (PDT). The PQL provides… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …to the best of my knowledge. **Job Description** **About the role** As Associate Director , Drug Product Manufacturing Science & Technology, you will be Takeda's ... pharmaceutical development and manufacturing. + Deep expertise in drug product manufacturing technologies for oral solid dosage forms and/or injectable products,… more
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