- Jazz Pharmaceuticals (Philadelphia, PA)
- …Description: The Associate Director position, Regulatory Affairs Global CMC is responsible for establishing global regulatory CMC Strategies for ... y . The Associate Director will have a strategic role in driving CMC Regulatory Strategies across multi-disciplinary teams , including leading the preparation of… more
- Insmed Incorporated (NJ)
- …of science, we're in. Are you?About the Role:The Associate Director, Regulatory Affairs, CMC will be responsible for reviewing the CMC post approval changes, ... providing regulatory impact assessments, and coordinating with regional RA- CMC leaders to formulate regulatory strategies for post-approval changes. This role will… 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
- Insmed Incorporated (NJ)
- …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, and combination ... of deviations, CAPAs, change controls, and protocols/reports.Collaborate cross-functionally with CMC team, Regulatory, Clinical Operations, and Program Management to… more
- Jazz Pharmaceuticals (Redwood City, CA)
- …management process. Partner with Quality, Regulatory Affairs, Regulatory Operations and CMC and Labeling organizations in inspection readiness forums. Assist with ... all inspection management activities across Regulatory Affairs, Regulatory Operations and CMC and Labeling including developing readiness and execution plans such as… 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
- Aequor (Thousand Oaks, CA)
- …job responsibilities. is searching for a Sr. Project Manager in our CMC Integration team within Operation Products Advancement in Process Development. This role ... experience in the Pharmaceutical, Biotechnology or other Healthcare related field, direct CMC experience is highly desirable Ability to foster collaboration and work… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …This effort will extend to participation in a variety of cross functional CMC and quality forums under the Joint Manufacturing Committee in the commercial governance ... and comparability protocols and reportsServe as reviewer/author of a variety CMC sections or regulatory submissions, risk assessments, validation impact assessments,… 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)
- …NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC guidance around drug development and manufacturing/supply processes Understands, ... development, registration and manufacturing of biopharmaceutical products in support of CMC applications Serves as corporate liaison with regulatory Health Authority… more
- Merck & Co. (Rahway, NJ)
- …process comparability reports, Process performance qualification, and/or regulatory submissions. CMC RA : Experience supporting/writing regulatory filings (IND, MAA, ... agencies (FDA, EMA, JNDA, TGA).- Leadership: -Establish, manage and support Cell Culture CMC teams, and align resources to deliver on priorities. Manage and mentor a… 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. Responsible for authoring the Clinical Supplies section of the study… more
- Merck & Co. (Rahway, NJ)
- …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 ... partners for timely execution of work.The successful candidate is expected to collaborate in a fast-paced, multidisciplinary, and highly matrixed team environment. The candidate is expected to be experienced in mammalian cell culture or purification process… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …analyses, data science, machine learning, predictive modeling methodsindustrial biologics CMC development or manufacturing experience, CAR-T experience is highly ... and comparabilityIndustry leading knowledge in technology transfer, process comparability, CMC regulatory guidelines and manufacturing in cell therapyAbility to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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
- Insmed Incorporated (San Diego, CA)
- …senior leadership, as neededCollaborate with Clinical Development, Clinical Operations, CMC , QA/QC, Nonclinical, Program Management, and external consultants to ... diseasesPrior experience serving as the regulatory lead on cross functional teams ( CMC , clinical and project teams)Ability and experience in the development and… more
- ACROBiosystems Inc. (San Jose, CA)
- …target discovery and validation, candidate drug screening and optimization, CMC development, preclinical and clinical studies, commercial production, and companion ... diagnostics. We are committed to excellence in providing quality products and services and accelerating the process of therapeutic development. Our mission is to accelerate the process of target therapeutic drug development. We aim to be a cornerstone company… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... & ensuring stable supply of product. - Primary activities include, but are not limited to: - Participates on the Clinical Trial Team (CTT) and collaborates closely with other functional area representatives to negotiate timelines and strategy for clinical… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …strategy.Collaborate closely with internal functions such as Pharmacology, CMC , Regulatory Affairs, Clinical, and Program Management.Maintain up-to-date knowledge ... of evolving regulatory guidelines and scientific advances in CGT toxicology.Has authority and should have the ability to make decisions on preclinical toxicology strategies and execution planRequirementsPh.D., DVM, or equivalent in Toxicology, Pharmacology, or… more
- Insmed Incorporated (NJ)
- …personnel and internal cross-functional stakeholders across disciplines of Manufacturing, CMC , Quality, Legal, Procurement and Finance. The ideal candidate would ... be a strong collaborator, self-motivated, and able to problem-solve to influence and lead work groups. This position reports to the Director, Supplier Relationship Management.What You'll Do: Responsibilities:Support supplier selection sourcing projects in… more
