- Merck & Co. (North Wales, PA)
- Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist / Director is responsible for developing and ... their assigned projects. Position Description- The Principal Scientist / Director responsibilities include but are not limited to:Serve as...responsibilities include but are not limited to:Serve as a Regulatory CMC Project Lead and provide … more
- Merck & Co. (Rahway, NJ)
- …in human through line of sight to commercial productionOversee and review CMC authoring activities for DP manufacturingEnsure successful and effective technology and ... knowledge and understanding of parenteral drug development process, and CMC related FDA and international regulations. Able to anticipate industry… more
- Merck & Co. (Rahway, NJ)
- …and a-vision to influence the regulatory environment.Nature and Scope of Position:The Director reports to the Executive Director of SMAR&D and will ... and sterile products.- It also includes strategic partnering with CMC and Regulatory in aspects of control...biochemical promcesses, parenteral, oral, and specialty dosage formulations.- The director should be well engaged with regulatory … more
- Insmed Incorporated (Bridgewater, NJ)
- …, Toxicology, is a key member of the nonclinical safety team, reporting to the Executive Director , Head of Toxicology and Molecular Mechanisms. In this role, you ... DABT/DACVP certification preferred. Minimum of 15 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …understanding of Pharma or life sciences manufacturing processes, cGMP practices, regulatory health authority CMC requirementsExperience with federal subsidy ... Position Summary The Director of Project Management will lead a team...promote project transparencyPrepare and deliver reports and presentations to executive leadership and other stakeholders Experience Requirements Ten (10)… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives. You will also influence… more
- Merck (North Wales, PA)
- **Job Description** Under general supervision of an Executive Director /Senior Director , the Principal Scientist / Director is responsible for developing ... their assigned projects. **Position Description** **The Principal Scientist / Director responsibilities include but are not limited to:** +...but are not limited to:** + Serve as a Regulatory CMC Project Lead and provide … more
- BeiGene (San Mateo, CA)
- …stage through clinical proof of concept. + Lead cross-functional team to author CMC / quality sections of regulatory submissions (INDs/CTDs). + Building scope and ... processes and analytics for cell therapy products. + Assembling relevant CMC data and authoring regulatory filing documents ( CMC sections) and responses to… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …Master in Management (MiM) Program. Reporting to the Assistant Dean & Executive Director for the Undergraduate Career Management Center and collaborating ... of our academic community. **Description** The Goizueta Business School is seeking a Director to lead the career development and recruiting efforts for the newly… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. Purpose: The purpose of the Senior Director / Executive Director , Global Regulatory Affairs, Global Regulatory ... drug development experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area + Knowledge… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …Consulting* Your Role The Bill and Melinda Gates Foundation is seeking a Deputy Director of Chemistry, Manufacturing and Controls ( CMC ) to join our Integrated ... Development (IDev) team. The CMC Deputy Director will lead a team...deliverability targets. + Play a strategic role in addressing CMC -related issues pertaining to regulatory interactions and… more
- Merck (Rahway, NJ)
- …human through line of sight to commercial production + Oversee and review CMC authoring activities for DP manufacturing + Ensure successful and effective technology ... + In-depth knowledge and understanding of parenteral drug development process, and CMC related FDA and international regulations. Able to anticipate industry trends… more
- Gilead Sciences, Inc. (Foster City, CA)
- …stakeholders. Collaborate with CMOs, Quality Control, Quality Assurance, External Manufacturing, Regulatory CMC , Process Development, Supply Chain and other ... regulatory inspections/audits. Participate in writing, reviewing and approving CMC sections of US and international clinical trial applications, regulatory… more
- Merck (Rahway, NJ)
- …vision to influence the regulatory environment. **Nature and Scope of Position:** The Director reports to the Executive Director of SMAR&D and will lead ... and sterile products. It also includes strategic partnering with CMC and Regulatory in aspects of control...biochemical promcesses, parenteral, oral, and specialty dosage formulations. The director should be well engaged with regulatory … more
- Vera Therapeutics (Brisbane, CA)
- Title: Director , Clinical Supply Chain Management Location: Brisbane, CA or Remote About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company ... for patients suffering from immunological diseases. Position Summary: We seek a Director , Clinical Supply Chain Management to join an experienced, fast-paced, and… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …input into the Clinical Development Plan, and it requires collaboration with clinical, regulatory , medical, CMC and Global Insights. + **Global Brand Strategy & ... Sr Director , Global Launch Readiness - Immunology Date: May...& Cross-Functional Leadership** , including partnership with R&D, Medical, Regulatory , Global Insights & Analytics, and coordination with regions… more
- AbbVie (Irvine, CA)
- …Research Group at AbbVie seeks an accomplished scientist and leader. The Director /Senior Principal Research Scientist will lead a team performing in vitro and ... productive, collaborative, and inclusive laboratory environment in compliance with regulatory and company expectations. Experience managing projects from early-stage… more
- AbbVie (Irvine, CA)
- …Research Group at AbbVie seeks an accomplished scientist and leader. The Director /Senior Principal Research Scientist will lead a team performing in vivo ... productive, collaborative, and inclusive laboratory environment in compliance with regulatory and company expectations. Experience managing projects from early-stage… more
- Bristol Myers Squibb (Princeton, NJ)
- …R&D Finance, and other enterprise functions. This role reports to the Executive Director , Drug Development Portfolio Strategy Implementation & Reporting (PSI&R), ... divisional management.. Expertise in R&D functions (eg, Clinical Operations, CMC , Regulatory , Project management, Commercial) preferred. Demonstrated… more
- Lilly (Cambridge, MA)
- …significant improvements in healthy outcomes for our customers. We are seeking an Executive /Senior Director - DDCS Drug Delivery and New Product Innovation to ... the Medicines Innovation Hub and the Business Units, as well as leaders in Regulatory and Manufacturing to define and deliver our strategy. This individual will be… more
