Senior Director of CMC Technical Innovation
3 weeks ago
Proclinical Staffing is seeking a seasoned professional to lead our Technical Operations team in Gene Therapy development. As a Senior Director of CMC Technical Innovation, you will drive technical innovation, enhance our capabilities, and maintain our position as a world leader in the industry.
Key Responsibilities:- Establish a centralized innovation framework to drive implementation of new technology and streamline IP engagement
- Expand our Technical Operations presence through publications, speaking engagements, and industry consortiums
- Screen, analyze, and negotiate potential technical collaborations from a scientific, financial, and strategic perspective
- Drive identification and enablement of novel technologies and cross-functional Technical Operations improvements
- Serve as the liaison to Technical Operations scientific and business teams to provide proposals to senior leadership and prioritize innovation in alignment with the organizational and Technical Operations strategy
- Demonstrate influential leadership capabilities and foster a collaborative team environment
- Lead organizational initiatives and represent Technical Operations on behalf of the organization
- Participate in project-related teams and other internal/external collaborations to support the client's objectives
- Bachelor's degree in Life Sciences or Engineering with 15+ years of relevant experience and 5+ years in a leadership role. Advanced degree preferred.
- Experience in end-to-end CMC drug development from early to late-stage development, GMP clinical and commercial operations, and regulatory submissions
- Proficient in GMP, GLP, and regulatory guidelines related to pharmaceutical development
- Excellent communication and interpersonal skills to help build strong relationships across scientific and business functions
- Extensive experience with the process and principles of development, technical transfer, scale-up design, drug substance/drug product unit operations, and analytical methods
- Excellent listener, seeks broad input and feedback, provides frequent and effective follow-up
- Solid understanding of statistical design and modeling of experiments
- Experience leading negotiations and executing agreements (e.g., material, license, etc.)
- Must have effective written and verbal communication skills
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Senior Director of Technical Innovation
1 month ago
Cambridge, Massachusetts, United States Proclinical Staffing Full timeJob SummaryWe are seeking a highly experienced Senior Director of Technical Innovation to lead our Gene Therapy team at Proclinical Staffing. As a key member of our organization, you will be responsible for driving technical innovation and advancing our Technical Operations platform.Key ResponsibilitiesEstablish a Centralized Innovation Framework: Develop...
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Senior Director of Technical Innovation
1 month ago
Cambridge, Massachusetts, United States Proclinical Staffing Full timeJob SummaryWe are seeking a highly experienced Senior Director of Technical Innovation to lead our Gene Therapy team at Proclinical Staffing. This is a permanent position based in Massachusetts.Key ResponsibilitiesDevelop and implement a centralized innovation framework to drive the implementation of new technology and streamline IP engagement.Expand our...
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Cambridge, Massachusetts, United States Apex Systems Full timeJob Title: Senior Director, Cell Therapy CMC/Process DevelopmentApex Systems is seeking a highly experienced Senior Director to lead process development, process scale-up, optimization, and technical transfer of Cell Therapy Products. This role will work closely with Contract Development and Manufacturing Organizations (CDMOs) for process development and...
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Head of Sustainable CMC and Innovation
14 hours ago
Cambridge, Massachusetts, United States Takeda Full timeJob SummaryAs the Head of Sustainable CMC and Innovation, you will lead the strategic integration of sustainability and digital innovation within the Chemistry, Manufacturing, and Controls (CMC) function. Your primary objective will be to champion our "In Silico" approach and ensure sustainability is embedded across all CMC activities, from research through...
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Head of Sustainable CMC and Innovation
2 weeks ago
Cambridge, Massachusetts, United States Takeda Pharmaceuticals Full timeAbout the Role:We are seeking a highly skilled and experienced professional to lead our Chemistry, Manufacturing, and Controls (CMC) function in a sustainable and innovative manner. As the Head of Sustainable CMC and Innovation, you will be responsible for championing our "In Silico first" approach and ensuring sustainability is embedded across all CMC...
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Senior Director, Regulatory Affairs CMC
15 hours ago
Cambridge, Massachusetts, United States Takeda Full timeAbout the Role:We are seeking a highly experienced Senior Director, Regulatory Affairs CMC to join our team at Takeda. As a key member of our Regulatory Affairs CMC team, you will be responsible for establishing collaboration with Global CMC teams and leadership through networks and enabling CMC regulatory team's success in meeting goals/objectives.Key...
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Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full timeJob OverviewStratacuity is seeking a highly experienced Senior Director to lead process development, process scale-up, optimization, and technical transfer of Cell Therapy Products. The ideal candidate will have a strong background in human pluripotent stem cell culture and differentiation or scale-up of allogeneic cell therapies.Key ResponsibilitiesProvide...
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Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full timeJob OverviewStratacuity is seeking a Senior Director to lead process development, scale-up, optimization, and technical transfer of Cell Therapy Products. This role will work closely with Contract Development and Manufacturing Organizations (CDMOs) for process development and manufacturing activities.Key ResponsibilitiesProvide strategic and technical CMC...
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Associate Director Regulatory Affairs CMC
5 days ago
Cambridge, Massachusetts, United States Agios Pharmaceuticals Full timeAssociate Director, Regulatory Affairs - CMCAgios Pharmaceuticals is seeking a highly skilled Associate Director of Regulatory Affairs - CMC to join our Regulatory Affairs team. As a key member of our team, you will be responsible for leading CMC regulatory strategy to support global development and lifecycle management.The Impact You Will MakeYou will be...
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Director, Regulatory Affairs CMC
1 week ago
Cambridge, Massachusetts, United States Takeda Full timeJob DescriptionTakeda is a global biopharmaceutical company committed to bringing innovative therapies to patients worldwide. We are seeking a highly skilled Director, Regulatory Affairs CMC to join our team.Key Responsibilities:Develop and execute regulatory CMC development and registration strategies for assigned products.Lead cross-functional teams to...
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Director, Regulatory Affairs CMC
3 weeks ago
Cambridge, Massachusetts, United States Takeda Full timeDirector, GRA CMC Small MoleculesTakeda is seeking a highly skilled Director, GRA CMC Small Molecules to lead the development and execution of regulatory CMC development and registration strategies. As a key member of the Global Regulatory Affairs CMC team, you will oversee the development and execution of regulatory CMC development and registration...
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Senior Manager, CMC Regulatory Expert
4 weeks ago
Cambridge, Massachusetts, United States Relay Therapeutics Full timeThe OpportunityWe are seeking a highly skilled Senior Manager, CMC Regulatory to join our Pharmaceutical Development team. As a key member of our team, you will play a critical role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs.This position requires weekly onsite presence and involves...
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Director, CMC Regulatory Affairs Specialist
3 weeks ago
Cambridge, Massachusetts, United States Takeda Full timeJob DescriptionTakeda is a global pharmaceutical company committed to delivering innovative therapies to patients worldwide. We are seeking a highly skilled Director, GRA CMC Small Molecules to join our team.Key ResponsibilitiesDevelop and execute regulatory CMC development and registration strategies for assigned products.Lead cross-functional teams to...
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Senior Manager, CMC Regulatory Expert
4 weeks ago
Cambridge, Massachusetts, United States Relay Therapeutics Full timeThe OpportunityWe are seeking a highly skilled Senior Manager, CMC Regulatory to join our Pharmaceutical Development team. As a key member of our team, you will play a critical role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs.Your RoleDevelop and execute CMC global submission plans and...
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Director of Chemistry Innovation
4 weeks ago
Cambridge, Massachusetts, United States Moderna Therapeutics Full timeAbout the RoleWe are seeking a highly skilled and experienced Director-level chemist to join our Discovery Chemistry group at Moderna Therapeutics. As a key member of our team, you will be responsible for leading the design and synthesis of novel LNP components and oligonucleotides, driving multiple research projects across various therapeutic areas.Key...
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Associate Director, Regulatory Affairs
3 weeks ago
Cambridge, Massachusetts, United States Agios Pharmaceuticals Full timeJob Title: Associate Director, Regulatory Affairs - CMCAgios Pharmaceuticals is seeking a highly skilled Associate Director of Regulatory Affairs - CMC to join our team. As a key member of our Regulatory Affairs department, you will be responsible for leading CMC regulatory strategy to support global development and lifecycle management.Key...
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Cambridge, Massachusetts, United States Takeda Pharmaceutical Full timeJob DescriptionTakeda is seeking a Senior Director and Regulatory Platform Lead for CMC, Device and Drug-Device Combinations Material Sciences to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing innovative regulatory strategies for pure device and combination product submissions, with a focus on...
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Associate Director, Analytical Development, CMC
3 weeks ago
Cambridge, Massachusetts, United States Agios Pharmaceuticals Full timeJob Title: Associate Director, Analytical Development, CMCAgios Pharmaceuticals is seeking a highly motivated and experienced Associate Director, Analytical Development, CMC to join our growing CMC team. As a key stakeholder within analytical development, you will be responsible for building and leading the analytical development function within CMC and...
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Senior Manager, CMC Regulatory Expert
1 week ago
Cambridge, Massachusetts, United States Relay Therapeutics Full timeThe OpportunityWe are seeking a highly skilled Senior Manager, CMC Regulatory to join our Pharmaceutical Development team. As a key member of our team, you will play a critical role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs.This position requires weekly onsite presence and involves...
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Cambridge, Massachusetts, United States Takeda Pharmaceutical Full timeJob OverviewWe are seeking a highly experienced Senior Director and Regulatory Platform Lead to join our team at Takeda Pharmaceutical. This role will be responsible for leading the development and implementation of innovative regulatory strategies for CMC, Device and Drug-Device Combinations Material Sciences.Key ResponsibilitiesDevelop and implement...