- Formation Bio (New York, NY)
- …in pharmaceutical sciences or engineering to drive successful drug product development and manufacturing operations.Responsibilities Technical Leadership: ... and more efficiently.About the PositionFormation Bio is seeking a motivated, experienced Director , Formulation Development to join our dynamic team. This… more
- Formation Bio (New York, NY)
- …strategic and tactical plans. Identifies and assesses regulatory risks associated with product development for Formation Bio's drug assets. Represents the ... MAAs, supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC guidance around drug development and manufacturing/supply processes… more
- Formation Bio (New York, NY)
- …patent and IP portfolio, where you will work closely with our business development , legal, clinical, CMC , and data/engineering teams to on-board products with ... features Comfortable working cross functionally, including partnering with clinical and CMC teams to identify patentable innovations during development ,… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in Philadelphia, PA or Somerset, NJ. Role OverviewWe are seeking a ... effects, immunogenicity, insertional mutagenesis, and long-term safety.Participate in the development of target product profiles and preclinical safety… 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 ... Director in Organon Regulatory Chemistry, Manufacturing and Controls ( CMC ), the Associate Principal Scientist is responsible for developing and implementing… more
- Organon & Co. (Plymouth Meeting, PA)
- …, regulatory affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls ( CMC ), medical affairs and business development are critical to ... oversee non-clinical activities and safety assessments for Organon Research and Development (R&D) programs ranging from discovery through late-stage development .… more
- Lundbeck (Deerfield, IL)
- … development , regulatory submission and launch. + Supports Lundbeck Product Labeling Committee activities as LPLC reviewer/Deputy Chair, coordinating and ... Director US Regulatory Global Strategic Labelling Requisition ID:...Affairs Global Strategic Labelling will lead and oversee the development of end- to- end (e2e) labelling process for… more
- Organon & Co. (Jersey City, NJ)
- …guidance on the pharmacokinetic performance of drug products during formulation development and the drug product life cycle, including interpretation ... knowledge-sharing events. + Contribute to and/or review the nonclinical, early clinical development or CMC documentation to support regulatory or other… more
- Organon & Co. (Plymouth Meeting, PA)
- …in written format. + Track record of effective functional representation on product development teams. + Excellent verbal and written communication skills. ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for contributing and/or devising the clinical pharmacology… more
- Insmed Incorporated (NJ)
- …what's possible for patients with serious diseases. Reporting to the Associate Director , Regulatory Affairs, Tactical Implementation, you'll have a critical role in ... across assigned programs and market. Under the guidance of the Associate Director , you will ensure high-quality, timely, and compliant preparation and delivery of… more
- Insmed Incorporated (NJ)
- …expand what's possible for patients with serious diseases. Reporting to the Director , Supplier Relationship Management , you'll partner closely with Commercial and ... personnel and internal cross-functional stakeholders across disciplines of Manufacturing, CMC , Quality, Legal, Procurement and Finance. The ideal candidate would… more
- 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 (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
- 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
- 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
- RTX Corporation (Largo, FL)
- …focus on operations and manufacturing program activities. This position reports to the Sr. Director of Operations for the Largo CMC . This position is Onsite at ... matrixed environment. A thorough understanding of factory manufacturing/operations, proposal development , schedule development , procurement, and build processes… more
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