- 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, ... of deviations, CAPAs, change controls, and protocols/reports.Collaborate cross-functionally with CMC team, Regulatory, Clinical Operations, and Program Management to… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible for reviewing the CMC ... changes, providing regulatory impact assessments, and coordinating with regional RA- CMC leaders to formulate regulatory strategies for post-approval changes. This… more
- Insmed Incorporated (NJ)
- …Are you?About the Role:This position is a key role that will provide regulatory CMC (RA CMC ) leadership and strategy to achieve regulatory approvals in various ... countries. As a strategic function, RA CMC is required to collaborate closely with multiple functions...regulatory strategies and identify the gaps and challenges of CMC development to ensure the approvability of the drug… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position?** Reporting to the Director in Organon Regulatory CMC ,?the Associate Principal Scientist is responsible for?developing ... and?implementing Regulatory Chemistry, Manufacturing & Controls ( CMC ) strategies for?assigned?small molecule products in accordance with global regulations… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... Commercial Manufacturing groups. The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in managing work with external… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... packaging activities as well as supply chain documentation to support critical CMC activities. Support the collection of clinical supply chain metrics and/or… more
- Formation Bio (New York, NY)
- …where you will work closely with our business development, legal, clinical, CMC , and data/engineering teams to on-board products with strong IP potential, and ... Comfortable working cross functionally, including partnering with clinical and CMC teams to identify patentable innovations during development, collaborating with… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing the ... supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC guidance around drug development and manufacturing/supply processes Understands,… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in ... NJ. Role OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety assessment activities… more
- Insmed Incorporated (San Diego, CA)
- …and for the future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the regulatory leader on cross-functional teams, where ... senior leadership, as neededCollaborate with Clinical Development, Clinical Operations, CMC , QA/QC, Nonclinical, Program Management, and external consultants to… more
- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:The Associate Director , Quality Control will be responsible for leading and overseeing all Quality ... combination products is preferred.Proficient in regulatory requirements, including cGxP, CMC , ICH, and compendial standards (USP/EP/JP).Excellent analytical and problem-solving… 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
- Programmable Medicine Operatin (Redwood City, CA)
- …Author and review technical documents such as protocols, reports, risk assessments, and CMC sections of regulatory filings Ability to review master batch records and ... participation in the annual bonus program. At the Associate Director level, the salary range for this position is...is $160,000 - $185,000 annually. The range for a Director is $185,000 $243,000. We consider various factors when… more
- Organon & Co. (Plymouth Meeting, PA)
- …affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls ( CMC ), medical affairs and business development. Non-Clinical Safety Assessment ... + Author or review the non-clinical, early clinical development or CMC documentation to support regulatory submissions to regional Health Authorities worldwide;… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Director , Biopharmaceutics will provide expert biopharmaceutical guidance on the pharmacokinetic performance of ... the general medicines portfolio of products marketed worldwide. The Associate Director , Biopharmaceutics will also be responsible for contributing to and reviewing… more
- Endo International (Horsham, PA)
- …we serve live their best life. **Job Description Summary** The Associate Director , Manufacturing Operations will provide leadership and management of operations at ... including Upstream Processing, Downstream Processing, and Manufacturing Support. The Associate Director is a member of the site leadership team and works… more
- Organon & Co. (Plymouth Meeting, PA)
- … Director in Organon Regulatory Chemistry, Manufacturing and Controls ( CMC ), the Associate Principal Scientist is responsible for developing and implementing ... Regulatory Chemistry, Manufacturing & Controls ( CMC ) strategies for assigned small molecule or biological products in accordance with global regulations and… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for contributing and/or devising the clinical pharmacology ... The Clinical Pharmacology Lead will serve as the medical monitor and/or study director responsible for the execution (in conjunction with the TMED Operations Lead)… more
- BeOne Medicines (San Mateo, CA)
- As Director of R&D Data Enablement / Data Products, you will lead the strategy and execution of building and scaling R&D data foundations and data products that ... Development, Clinical Operations, Global Statistics & Data Science, Safety, Regulatory, CMC , Portfolio). + Hands-on experience with modern data platforms and tools… more
- Programmable Medicine Operatin (Redwood City, CA)
- …to treat diseases with unprecedented precision. This position reports to the Director , Analytical Research and Development and will develop analytical methods and ... skills. *Technical writing experience such as protocols, reports, SOPs, and preparing CMC sections of IND. *Knowledge of GLP & GMP requirements *Well organized… more
