- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical coding services for ... reporting of safety data, pharmacovigilance, industry best practices, and relevant regulatory requirements. This position has experience working within the medical… more
- Genmab (Plainsboro, NJ)
- …Supply Manager , of the following tasks:Global Clinical Drug Supply Project /Trial ManagementObtain Project /Trial specific information to initiate drug supply ... CMC ) and support strategic cross functional collaboration (ie, project /program and trialsLead/Participate in Clinical Project Supply Team… more
- Novo Nordisk Inc. (Durham, NC)
- …data science to help develop & drive digital transformation and automate across CMC Development & Scaling. Work with linear mixed models, design of experiments, ... develop & teach courses and workshops in statistical topics. Relationships Senior Manager . Essential Functions Provide statistical support and probability data as it… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill a Senior Manager of CMC Industry and Regulatory Intelligence position. In this role, you would be responsible for enabling ... CMC operations across Regeneron. As a Senior Manager of CMC Industry and Regulatory...Strong communication skills, both oral and written. + Strong project management leadership skills essential + Good understanding of… more
- Kelly Services (Seattle, WA)
- Kelly(R) Science & Clinical is seeking a Manager , CMC Regulatory Affairs for a direct hire opportunity with one of our clients, a commercial-stage ... and Cell Therapies and/or other biologics. **Responsibilities** + Provides CMC regulatory support and guidance to project teams for clinical development and… more
- Actalent (North Billerica, MA)
- … CMC systems, regulatory requirements, and GMP + Experience authoring CMC regulatory sections, including INDs/CTAs + Knowledge of PET Good Manufacturing ... scientific resource for complex projects + Act as a CMC representative on core projects, manage project ...in the pharmaceutical industry + Strong experience in authoring CMC regulatory sections Work Environment The role… more
- West Pharmaceutical Services (Exton, PA)
- …latest guidance documents and current state-of-art standards/regulations. + Collaborate with regulatory lead(s), cross-functional project manager (s) and SMEs ... Sr. Specialist, Regulatory Project Management (Evergreen Posting) Requisition...IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical… more
- Fresenius Medical Center (Knoxville, TN)
- …to comply with regulatory requirements + Organization of submission-readiness of regulatory documentation (eg, CMC relevant parts) + Organize and support ... The internal Job Title is called **Global Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products).** **Main Responsibilities:** + Support as … more
- Gilead Sciences, Inc. (Foster City, CA)
- …will be responsible for the planning and execution of multiple small molecules and/or biologics CMC programs. The Sr. Project Manager will partner with PDM ... Management** **Location: Foster City** **Specific Responsibilities:** The Senior Project Manager in PDM Portfolio Strategy and...CMC development and commercial teams, GMP environment and regulatory affairs + Prior experience in project … more
- J&J Family of Companies (Spring House, PA)
- …Safety (PSTS) areas of expertise. + Drive strategic decisions, facilitate successful project execution, and achieve key CMC and PSTS deliverables within ... the CMC team, PSTS team, project management team (PMT), based upon available data, assumptions,...excellence is preferred + Experience with clinical development and regulatory affairs is preferred + Project Management… more
- Sokol Materials & Services (Skillman, NJ)
- Validation Engineer - Project Manager Job Location Job Type Workspace Summit, NJ Lead On-site position (no remote or hybrid options) Target Hiring Date February ... 15 pounds as needed. About the Role * The Project Manager will develop project ...Supply Chain, MS&T, Quality Assurance, Quality Control, Process Development, CMC , TT lead, TCT lead, Global Engineering, Facilities Engineering,… more
- Integra LifeSciences (Plainsboro, NJ)
- …are challenging what's possible and making headway to help improve outcomes. The **Senior Project Manager ** is a key member of the value stream leadership team ... for Integra's Collagen Manufacturing Center ( CMC ) in Plainsboro, NJ. Reporting to the assigned value...Plainsboro, NJ. Reporting to the assigned value stream manufacturing manager , this position is responsible for leading cross-functional teams… more
- Eurofins (Raleigh, NC)
- …GMP product testing laboratories worldwide. Eurofins BPT provides comprehensive CMC laboratory services for the world's largest pharmaceutical and biopharmaceutical ... control. Position Summary Eurofins BPT is seeking a results-oriented Regional Sales Manager to join our team, focusing on facility validation and environmental… more
- AbbVie (Irvine, CA)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The PDS&T Program Manager is an experienced leader responsible for managing large global projects ... across disciplines and multiple manufacturing locations. This person has previous project management experience and is working on expanding into managing various… more
- Sanofi Group (Waltham, MA)
- **Job title** : Head of Bioanalytics GMU **Grade:** L5-1 **Hiring Manager :** Laurent Duhau **Location:** Waltham, MA **About the Job** Are you ready to shape the ... helping our teams accelerate progress. Within Sanofi R&D, Global CMC Development is a key enabler of Sanofi's growth...strategic inputs and resources as well as securing the project deliverables. We are an innovative global healthcare company… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …but not limited to, Clinical Operations, Chemistry, Manufacturing and Controls ( CMC ), Product Quality Assurance (PQA), Regulatory Affairs and Sourcing ... and creating hope for all facing illness. The Senior Manager , Clinical Supplies will manage the complete clinical supply...any current or potential new CPOs. + Collaborates with Regulatory Affairs to provide all documents required for IND,… more
- J&J Family of Companies (Raritan, NJ)
- …initiatives in partnership with Global Labelling Product Leaders, Supply Chain, Marketing, Regulatory Affairs, CMC Regulatory Affairs, Product Artwork, and ... Johnson & Johnson is recruiting for a Manager , Global Labeling Operations to be located in...of Global Labeling Operations, including : + Provision of Regulatory guidance on the development of US packaging text… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of Risk Management activities. + Through close collaboration with Pharmaceutical Science and Regulatory CMC and partnering with the Head of Quality Systems & ... to the best of my knowledge. **Job Description** **_OBJECTIVES/PURPOSE_** The Principal Manager in PSDQ Systems will perform the following high-level objectives: +… more
- Amgen (Washington, DC)
- …with domestic and international CMOs/CROs + Solid understanding of cGMP, Regulatory / CMC , legal, quality requirements, and import/export policies + Self-starter ... the lives of patients while transforming your career. **Contract Manufacturing Manager (Oligonucleotides, Peptides)** **What you will do** Let's do this! Let's… more
- ERP International (Lemoore, CA)
- …maintains satellite offices in Montgomery, AL and San Antonio, TX - plus project locations nationwide. ERP is an Equal Opportunity Employer - Disability and Veteran. ... Joint Commission, URAC, Case Management Society of America (CMSA), and other regulatory requirements. Apply medical care criteria (eg, InterQual). Provide input on… more
