- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team ... (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2, pre-NDA, Type… more
- Eisai, Inc (Exton, PA)
- …as well as with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics Operations ... If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a… more
- Merck & Co. (Upper Gwynedd, PA)
- …, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is responsible ... CMC - Associate Principal Scientist, CMC...guidances, and is-responsible for the preparation and submission of CMC dossiers for all assigned development products. -Primary responsibilities… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... / our Research & Development Division ) such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of portfolio, initiatives for… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ( CMC ) ... and regulatory leaders.Responsibilities Strategic Leadership Develop and execute comprehensive CMC strategies for pre-clinical, clinical, and commercial-stage biologic products,… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... and packaging activities as well as supply chain documentation to support critical CMC activities. - - Support the collection of clinical supply chain metrics and/or… more
- Merck & Co. (Rahway, NJ)
- …cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for ... of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic… 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
- Organon (Plymouth Meeting, PA)
- Job Description The Position The Associate Principal Scientist (Associate Director ) is responsible for developing and implementing Regulatory Chemistry, ... Manufacturing & Controls ( CMC ) strategies for assigned small molecule and/or biological products...Principal Scientist will lead the preparation and submission of CMC dossiers for programs in clinical development, marketing applications… more
- Olema Oncology (San Francisco, CA)
- …better, longer. For more information, visit us at www.olema.com. About the Role Director , Regulatory Labeling As the Director , Regulatory Labeling, reporting to ... Affairs, Clinical Development, Clinical Supply (CS), Quality Assurance (QA), and the CMC teams as well as external vendors (clinical research / development and… more
- Ionis (Carlsbad, CA)
- …managing two team members and partnering closely with manufacturing leadership. The Director will oversee cost accounting activities, support CMC operations, ... to our unique culture while you develop and expand your career! Director , Manufacturing Cost Accounting SUMMARY: We are seeking an experienced and strategic… more
- GenScript/ProBio (Piscataway, NJ)
- …drug development for customers. ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing ... and commercial manufacturing. Position: Associate Director , Regional Marketing & Product Management Location: Piscataway, New Jersey Report to: Global Head of… more
- Healthcare Staffing Plus (Missoula, MT)
- …as stroke, traumatic brain injury, and severe burns. POSITION SUMMARY The Director of the Laboratory is a qualified professional with appropriate clinical training ... the overall operations of laboratory services in the medical center. The Director is responsible for all personnel, budget, planning, capital equipment and… more
- Eli Lilly and Company (Indianapolis, IN)
- …analytical chemists, bioconjugation scientists, biologics development team, engineers, CMC project management, Lilly manufacturing partners, and regulatory ... scientists to develop and commercialize ADCs. Manage multiple projects and/or material deliveries simultaneously. Oversee phase appropriate development activities such as route selection, process definition, and process characterization. Partner with external… more
- Atlantic Health System (Morristown, NJ)
- …all team members. Offerings vary based on role level (Team Member, Director , Executive). Below is a general summary, with role-specific enhancements highlighted: ... Security Services (PSS) team provides 24/7 security coverage at our medical centers and ( CMC , HMC, MMC, NMC, OMC, and Union ED) and is responsible for ensuring the… more
- Shuvel Digital (Reston, VA)
- …Has supervisory and developmental responsibilities within a functional area. The program director manages one or more projects or programs, may manage an operating ... ITIL Certification (Information Technology Infrastructure Library) Certified Management Consultant ( CMC ) Leadership in Energy and Environmental Design (LEED) Lean… more
- GenScript/ProBio (San Francisco, CA)
- …drug development for customers. ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing ... for current services/products Work with the RSAM, technical account managers (TAM) and Director of Sales to develop an action plan designed to secure business in… more
- Eagle County Schools (Edwards, CO)
- …your PERA retirement plan, paid holidays, paid leave, tuition reimbursement, free CMC credits, amongst others. For full time employees. HIRING SALARY RANGE: $25.00 ... Communicate regularly with direct supervisor. Training: Assist program teams, ECE School Director and ILT in development and implementation of training as requested… more
- AbbVie (Irvine, CA)
- …. Job Description Further develop your expertise and join our team as Director , CMC Product Development. Must have Medical Device experience. The Product ... Development Director (PDD) will be a member of the Operations...for pipeline programs from a Chemistry, Manufacturing, and Controls ( CMC ) perspective. They will lead the Product Presentation and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics is responsible ... portfolio. This position will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining the global… more
