- Insmed Incorporated (NJ)
- …Agencies as the lead in agency interactions and product development meetings.Understanding of scientific principles and regulatory CMC requirements relevant ... relevant FDA, EU, ICH, PMDA guidelines, initiatives and regulations governing CMC drug product development .Ability to deal with issues of critical… more
- Insmed Incorporated (NJ)
- …quality, consistent, and complete.Establish product specific strategies to ensure successful development of CMC submission packages to support product ... of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible...strategies for post-approval changes. This role will also lead CMC regulatory strategy development and implementation in… more
- Insmed Incorporated (NJ)
- …each other, and for the future of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics, ... lifecycle changes, process optimizations, and continuous improvement initiatives across development programs.Responsible for final product Quality release/rejection… more
- Organon & Co. (Plymouth Meeting, PA)
- …responsibilities include, but are not limited to:? **Responsibilities** + Serve as the? CMC Product Lead?for assigned products and be?accountable for the delivery ... **Job Description** **The Position?** Reporting to the Director in Organon Regulatory CMC ,?the Associate...of all regulatory milestones for?assigned?products through the product lifecycle.?? + Lead development and execution… 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
- Merck & Co. (Rahway, NJ)
- …late-stage pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics ... upstream and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial… 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
- Merck & Co. (Rahway, NJ)
- …compound(s)/ program(s). The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting ... pipeline (ie clinical development , CMC , supply chain, & human health),...supporting all protocol and program cost estimates requested by Product Development Teams. Responsible for authoring clinical… more
- Insmed Incorporated (San Diego, CA)
- …regulatory review of documentation prepared by other technical functions supporting product development activities (eg, clinical protocols, clinical study ... RAC certification desired10+ years of experience in Regulatory Affairs, and product development experience within the pharmaceutical or biotechnology industry,… 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. (Plymouth Meeting, PA)
- …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 . Non-Clinical Safety ... strategic non-clinical safety (toxicological) input into Organon's pipeline programs, business development activities, and existing product portfolio as an ADT… more
- Programmable Medicine Operatin (Redwood City, CA)
- …Oversee the execution of activities associated with injectable and solid oral drug product development and manufacturing, supporting clinical development and ... to focus on leading our contract manufacturing efforts including Drug Substance and Drug Product . The successful candidate will be required to work on site 5 days… 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. (Jersey City, NJ)
- …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
- BeOne Medicines (San Mateo, CA)
- …MedDRA, internally defined ontologies / standards) embedding FAIR data principles. **Data Product Development ** + Build a portfolio of high-value data products ... As Director of R&D Data Enablement / Data Products,...modern data platforms and tools (Databricks for data lakehouse/ product development , Informatica for cataloging and quality,… more
- Programmable Medicine Operatin (Redwood City, CA)
- …us to treat diseases with unprecedented precision. This position reports to the Director , Analytical Research and Development and will develop analytical methods ... in Redwood City, is seeking a motivated Chemist/Sr. Chemist Analytical Method Development . We are focused on developing novel nanomedicines, HD therapeutics (HDTs),… more
- Insmed Incorporated (NJ)
- …personnel and internal cross-functional stakeholders across disciplines of Manufacturing, CMC , Quality, Legal, Procurement and Finance. The ideal candidate would ... and lead work groups. This position reports to the Director , Supplier Relationship Management.What You'll Do: Responsibilities:Support supplier selection sourcing… more
- CSL Behring (Waltham, MA)
- …decisions. -Candidates have developing knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product ... proactively contributes and builds effective relationships with respective members of Product Strategy Team (PST), Clinical Development Team (CDT), Safety… 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
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