- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description + Represents all CMC areas on the AST serving as spokesperson for the CMC ... in communications and meetings with regulatory agencies. Accountable for creating CMC development plan incl. risks and mitigations in collaboration with line… more
- BeiGene (San Mateo, CA)
- …identify key regulatory CMC issues and mitigation activities needed throughout product life cycle. Escalate critical issues to senior management. + Lead ... during product lifecycle for assigned projects. + Provide regulatory CMC review of clinical protocols and investigator brochures, etc. for assigned projects.… more
- System One (San Rafael, CA)
- Job Title: Senior Manager - CMC ...relevant requirements. + Collaborating and staying aligned with Reg CMC Product Lead to assess change records ... Hybrid - Local to San Rafael, CA Type: Contract Description: As a Senior Manager in the Regulatory CMC department this individual will be… more
- AbbVie (North Chicago, IL)
- …The leveling of this position is flexible. Applicants may be considered for the Senior Manager or Associate Director level based on qualifications. This role is ... areas, Operations, and Research & Development (R&D) organizations. Represents CMC on teams such as product development,...organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams, and… more
- System One (San Francisco, CA)
- Title: Senior Manager , QA Operations Location: The position will be remote, with a preference of CA residency. Travel: Up to 25% travel may be necessary in order ... to effectively oversee CDMO's POSITION SUMMARY Senior Manager , QA Operations. + In this role you will be responsible for Quality Assurance oversight of one or… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted ... May represent manufacturing on one or more cross-functional Development or Commercial CMC teams with responsibility for proactively managing product strategy… more
- Integra LifeSciences (Plainsboro, NJ)
- …of us 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 stream manufacturing manager , this position is… more
- AbbVie (North Chicago, IL)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Overview The Senior Program Manager , Factory of the Future (FotF) Transformation will ... will support the development of long-range plan strategy and execution plans. The Senior Program Manager will also support subsequent site discovery and creation… more
- United Therapeutics (Silver Spring, MD)
- …and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Senior Regulatory Affairs Manager partners with senior regulatory ... Contribute to the development and implementation of sound preclinical, clinical and CMC regulatory strategies that support the clinical and commercial development of… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …This includes providing analytical chemistry expertise for method development and product improvement initiatives. The Senior Analytical Chemist will be ... Job Title Senior Analytical Chemist Requisition JR000014680 Senior ...established standards, with a key focus on drafting regulatory CMC submission documents. + Develop creative and collaborative solutions… more
- Bausch Health (Petaluma, CA)
- …and designs experiments in accordance with QbD/aQbD principles. Designs and executes CMC studies to support product specifications profile development and ... with accuracy and in accordance with established procedures + Effectively communicates with Manager , team members, and Senior Management + Organized and able to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …execution of multiple small molecules and/or biologics CMC programs. The Sr. Project Manager will partner with PDM Product Strategy Team Leads to manage a ... Manager , Project Management** **Location: Foster City** **Specific Responsibilities:** The Senior Project Manager in PDM Portfolio Strategy and Operations… more
- Merck (West Point, PA)
- …within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities ... at clinical development related meetings (ie, Clinical Trial Teams) and product development related meetings. The incumbent must have demonstrated understanding of… more
- Takeda Pharmaceuticals (Boston, MA)
- …unmet medical need, competitive landscape, and key TPP attributes required to bring the product to market and to ensure global access for patients in context of ... on the sub-team objectives. + Accountable with the responsible Global Program Manager for activities operating budgets within the global program; leads budget… more
- Merck (Rahway, NJ)
- …Management Section of the GCS Planning organization. Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates strategic ... clinical site. The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie… more
- ThermoFisher Scientific (San Francisco, CA)
- …making sure our food is safe or helping find cures for cancer. **Program Manager III** **Requisition ID:** When you join us at Thermo Fisher Scientific, you'll be ... to all collaborators. Know when to advance issues to senior leadership for resolution. + Demonstrate role model leadership...will have greater than 5 years validated experience in CMC and CDMO processes. + Should possess validated understanding… more
- Merck (Rahway, NJ)
- …stakeholders + Proven ability to select, secure and manage external vendors at a senior manager level to achieve results and control expenditures + Demonstrated ... in all aspects of clinical supply chain logistics, influences senior leaders in defining our company's strategy + Recognized...submissions + Experience with one or more aspects of CMC development, spanning from discovery to product … more
- Amicus Therapeutics (Princeton, NJ)
- …Management represents Program Management in the Brand Leadership Team. A Manager , Program Management provides support to the Executive Director, Program Management ... Management team to drive program goals by ensuring creation/updates of Target Product Profiles and Development Plans to support product vision, documenting… more
- West Pharmaceutical Services (Exton, PA)
- …environment and planet through our sustainability efforts. **Job Summary:** This Senior Specialist, Regulatory Project Management (RPM) role is responsible for ... state-of-art standards/regulations. + Collaborate with regulatory lead(s), cross-functional project manager (s) and SMEs (Subject Matter Experts) in R&D, quality… more
- Serco (VA)
- …to in-service that will run in parallel with the COLUMBIA Program. Supports the Senior UK Program Manager with Serco under the UK Dreadnought Through-Life ... the turnover of government and industry Common Missile Compartment ( CMC ) ILS products to the United Kingdom (UK) in...products are on schedule and stakeholders are aware of product receipt. + You will collaborate with program/department managers… more