- Merck & Co. (Rahway, NJ)
- …strong industry and FDA connections to our company. They will lead a team of CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of ... to patients in markets as needed.-Primary Responsibilities:Lead a small team of CMC regulatory scientists responsible for new modality or traditional solid-oral… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …preferredExtensive knowledge in process development, technology transfer, process comparability, CMC regulatory guidelines, process monitoring and manufacturing ... Janssen. This effort will extend to representing MSAT on joint technical and CMC committees. The candidate will also be required to collaborate within a cross… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and comparabilityIndustry leading knowledge in technology transfer, process comparability, CMC regulatory guidelines and manufacturing in cell therapyAbility ... analyses, data science, machine learning, predictive modeling methodsindustrial biologics CMC development or manufacturing experience, CAR-T experience is highly… more
- Merck & Co. (Rahway, NJ)
- …Development, Large Molecule Assay Validation, Quality Assurance, Technical Operations, and CMC Regulatory Affairs, to address technical challenges, provide ... scientifically sound guidance at each stage of development, and effectively manage deliverables to progress the pipeline. - Responsibilities Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in-process testing of Biologics… more
- Merck & Co. (Rahway, NJ)
- …Analytical Development, External Capabilities, Quality Assurance, Technical Operations, and CMC Regulatory Affairs, to address technical challenges, provide ... scientifically sound guidance at each stage of development, and effectively manage deliverables to progress the pipeline. - Responsibilities Validate and implement analytical methods to support release and stability testing of clinical materials. Execute Good… more
- Merck & Co. (San Diego, CA)
- …partnering necessary for pharmaceutical development with Translational Medicine, Clinical, CMC , Regulatory , Operations, and other functional areas.Effective ... communication, collaboration, and negotiation skills with the ability to work with senior level managers in meeting venues that include multiple cross-functional representatives.Participate in cross functional collaboration and support in the preparation of… more
- Insmed Incorporated (San Diego, CA)
- …leadership within gene therapy or orphan (rare) diseasesPrior experience serving as the regulatory lead on cross functional teams ( CMC , clinical and project ... Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director, Regulatory Affairs will serve as the regulatory leader on… more
- Protagonist Therapeutics (Newark, CA)
- …ability to effectively lead projects with internal and external resources. Experienced with regulatory CMC filings in IND, NDA, IMPD, PAS covering all phases ... in identification and qualification of impurities. Contribute to Quality and CMC -related regulatory correspondence. Maintain a current understanding of peptide… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and negotiate contracts.Lead cross-functional teams and collaborate with Quality, Legal, CMC , MSAT, Manufacturing, Supply Chain, and Regulatory to prepare ... alternate/secondary sourcing strategies.Achieve cost savings objectives for product competitiveness.Support CMO contract negotiations in conjunction with alliance management.Ensure target inventory levels are maintained and reported monthly.Build and nurture… more
- Merck & Co. (Rahway, NJ)
- …teams working on Autoinjectors, fostering collaboration among engineering, quality assurance, regulatory , and manufacturing teams across the CMC ecosystem. Key ... medical device engineering, particularly in the design, manufacturing, and regulatory aspects of Autoinjectors and combination products.Primary Responsibilities:Technical Strategic… more
- Lundbeck (Bothell, WA)
- …Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has ... capacity, manage outsourced cell line development activities, author relevant regulatory sections, collaboratively support cell culture development to optimize… more
- Merck & Co. (Rahway, NJ)
- …of business functions including Technology, Manufacturing Operations, Finance, Regulatory , Quality, Compliance, Supply Chain and Commercial. Understanding of ... product development lifecycle and integration of CMC and clinical strategy and ability to engage to ensure product is positioned to reliably launch with appropriate… 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 ... our external contract manufacturing network while ensuring compliance with cGMP, regulatory requirements. This is an individual contributor, hands-on position. As… more
- Merck & Co. (Rahway, NJ)
- …dosage. This role involves collaborating with stakeholders across the end-to-end continuum of CMC areas and requires both an understanding of packaging as well as ... specifications, and qualification activities, while ensuring compliance with all regulatory standards and sustainability goals. Individuals in this role will… more
- Merck & Co. (Rahway, NJ)
- …human health. In this role, the individual will be responsible for leading CMC project teams and the formulation development of new chemical entities through a ... Process Development, Professional Collaboration, Professional Networking, Quality by Design, Regulatory Filings, Strategic Thinking, Technology Transfer-Preferred Skills:Job Posting End… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …limited to Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC , and IT. This individual will support the MES team with electronic ... Global Procedures.Support Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.Establish key stakeholder relationships with internal and… more
- HCA Medical City Fort Worth Hospital (Fort Worth, TX)
- …treatments, to the medical team promptly. Ensure compliance with regulatory standards, documentation requirements, and quality improvement initiatives. Quality ... conferences, workshops, and pursuing certifications related to cardiovascular nursing (eg, CCRN, CMC , CSC). Client Details Address 900 8th Ave City Fort Worth State… more
- Lilly (Philadelphia, PA)
- …communities through philanthropy and volunteerism. **Position Overview:** The Manager, Manager- CMC Regulatory is responsible for the preparation and delivery ... of high-quality CMC regulatory submissions. This position supports Lilly/Avid diagnostic radiopharmaceutical marketed products globally. **Responsibilities:** +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of experience in digital or innovation roles preferred. + Strong understanding of CMC regulatory submissions and the structure/content of Module 3. + ... **1. Strategy and Roadmap Development** + Define and continuously refine a CMC RA Digital Enablement roadmap aligned to organizational priorities and enterprise… more
- Merck (Rahway, NJ)
- …strong industry and FDA connections to our company. They will lead a team of CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of ... as needed. **Primary Responsibilities:** + Lead a small team of CMC regulatory scientists responsible for new modality or traditional solid-oral small molecules… more
