- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA CMC Pharmaceuticals Development Portfolio Lead where you ... CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs -...Pharmaceuticals. **How you will contribute:** + Leads the Early Development Pharmaceuticals GRA CMC regulatory team in… more
- AbbVie (North Chicago, IL)
- …functional representatives from various departments and divisions. Accountable for creating a CMC development plan in collaboration with line functions and the ... with respect to science, technology, compliance and cost effectiveness. + Leads CMC development teams for assigned projects: schedules meetings, develops… more
- Lilly (Indianapolis, IN)
- …global program team/governance and translate clinical, asset and portfolio strategy into clear CMC development and delivery goals for cross-functional CMC ... to ensure project success. + Support Due Diligence efforts by leading CMC development assessments, and integrate, stakeholder communication regarding key… more
- Takeda Pharmaceuticals (Boston, MA)
- …with international Health Authorities as necessary, directly and indirectly. Provide regulatory CMC expertise for new business development /due diligence ... oversee the development and execution of regulatory CMC development and registration strategies. RA ...process development and enhancement + Evaluate new business development opportunities or participate on due… more
- Regeneron Pharmaceuticals (Troy, NY)
- The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls ( CMC ) quality and compliance ... into action and influence policy and standards for all CMC operations across Regeneron. As a Director ...development and commercialization process, with a focus on CMC + Experienced in understanding and interpreting regulatory guidelines… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or to the governance bodies. **Responsibilities** - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case ... development candidates within the team to support overall CMC development plan. - Represent CMC...operational teams, other functions in Technology Unit, and key business partners. - Requires preparation and presentation of comprehensive… more
- Gilead Sciences, Inc. (Foster City, CA)
- …**Associate Director , Analytical Regulatory Sciences, Systems & Operations in CMC Reg Affairs:** **_*This is a site based position located in Foster ... City, CA_** The Associate Director , Analytical Regulatory Science, collaborates with product development...Commitments, and People Leader Accountabilities. + May participate in business process development initiatives or represent the… more
- AbbVie (North Chicago, IL)
- …the short and long-range plans. + Identify emerging regulatory trends impacting CMC development and proactively drive best practices to maintain/build compliant ... Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Dossier Leadership will lead...and career growth while developing staff in alignment with business needs, external factors, and individual development … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …strategies are implemented and project execution is on target + Evaluate new business development opportunities or participate on due diligence teams. + Develops ... How you will contribute: **OBJECTIVES** + Leadership in for the development and implementation of innovative pure device and combination product regulatory… more
- Regeneron Pharmaceuticals (Troy, NY)
- Leads the Chemistry, Manufacturing, and Controls ( CMC ) non-antibody team for cell and gene therapy technologies. The candidate will be responsible for assuring ... development and execution of global regulatory strategies for assigned...policies + Provide and drive strategic and operational global CMC regulatory direction and documentation for portfolio of CGT… more
- Hubbell Power Systems (Hamilton, OH)
- Business Unit Director ( CMC ) - Hamilton, OH Apply now " Date: Oct 11, 2024 Location: Hamilton, OH, US, 45015-1369 Company: Hubbell Incorporated Job Overview ... Responsible for all Product Management and Engineering activities to assigned CMC products to maximize product line gross margin and unit volume growth. Provide all… more
- AbbVie (Worcester, MA)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: The Associate Director in CMC Statistics is responsible for providing statistical ... in nonclinical areas with a focus on Chemistry, Manufacture and Control ( CMC ), expanding and broadening the application of Biostatistics. He/she is also responsible… more
- Organon & Co. (Plymouth Meeting, PA)
- …include, but are not limited to: **Responsibilities** + Partner with Research & Development , Manufacturing & Supply, Business Development and Commercial to ... Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products,... scientists in the Organon franchise teams. + Lead development and execution of regulatory CMC strategies… more
- AbbVie (Worcester, MA)
- …Instagram, YouTube and LinkedIn. Job Description Position will be responsible for CMC leadership and project management for existing and new biologics projects from ... plans, budgets, timelines and strategy; biologics projects at all stages of development are included, from phase I through commercial. *Must present technical… more
- Takeda Pharmaceuticals (Boston, MA)
- …goals. + Provide strategic scientific leadership and program management for multiple global CMC development teams dealing with complex development programs ... therapeutic areas, and regions (US, JP, EU). + Deliver excellence in leadership, CMC strategy development , and implementation of the strategy in alignment with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Accountabilities. + May have cross-functional leadership roles and may participate in business process development initiatives or represent the company in ... member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we… more
- AbbVie (North Chicago, IL)
- …operational excellence within Biologics Analytical R&D and in line with the Biologics CMC Development /AbbVie strategy for NBEs. + Recruit, promote, and retain ... to deliver high-quality drug products for patients. The Director , Biologics ARD will lead the Analytical Development...interfaces with other functions inside and outside of Biologics CMC Development and R&D. + Assures compliance… more
- Lilly (Indianapolis, IN)
- …goals are met. + Leading critical business decision-making as part of the business and strategic plan including the development of the technical agenda to ... product, process validation, process controls, compliance, continuous process optimization, CMC regulatory support, manufacturing data analysis and process data… more
- Spark Therapeutics Inc. (Philadelphia, PA)
- …making on programs / projects + Contribute to technical due diligence evaluations of business development opportunities + Model the company's values & culture in ... Scientific Director - Upstream Process Development **Date:** Oct...both lab scale and manufacturing scale. + Represent Process Development group on cross-functional CMC teams, working… more
- Merck (West Point, PA)
- **Job Description** **Job Description:** **End-to-End Technical Product Leadership: Development and Commercialization Team (DCT) Leader Role in Small Molecule Global ... Science, Engineering, & Commercialization (SM GSEC)** The Director , DCT Leadership position in the Manufacturing Division is a dedicated full-time role and is… more