Current jobs related to Senior Director CMC Technical Innovation - cambridge - Proclinical Staffing

  • Senior Director of CMC Technical Innovation

    1 month ago

    Cambridge, Massachusetts, United States Proclinical Staffing Full time

    Senior Director CMC Technical InnovationProclinical 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...

  • Senior Director CMC Technical Innovation

    2 months ago

    Cambridge, United States Proclinical Staffing Full time

    Senior Director CMC Technical Innovation - Gene Therapies - Permanent - Massachusetts Proclinical is seeking a Senior Director of CMC Technical Innovation to focus on Gene Therapy. This role requires a combination of CMC technical expertise (e.g. gene therapy, RNA, gene editing), effective communication, business and strategic acumen. Primary...

  • Senior Director of Technical Innovation

    2 months ago

    Cambridge, Massachusetts, United States Proclinical Staffing Full time

    Job 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...

  • Senior Director of Technical Innovation

    2 months ago

    Cambridge, Massachusetts, United States Proclinical Staffing Full time

    Job 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...

  • Associate Director

    3 weeks ago

    Cambridge, United States Alkeus Pharmaceuticals, Inc. Full time

    About Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge, Mass., Alkeus was founded in 2010 since that time has been developing its lead compound, gildeuretinol acetate (ALK-001). Designated as a...

  • Associate Director

    3 weeks ago

    Cambridge, United States Alkeus Pharmaceuticals, Inc. Full time

    About Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge, Mass., Alkeus was founded in 2010 since that time has been developing its lead compound, gildeuretinol acetate (ALK-001). Designated as a...

  • Senior Director, Cell Therapy CMC/Process Development Lead

    3 weeks ago

    Cambridge, Massachusetts, United States Apex Systems Full time

    Job 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...

  • Associate Director, Regulatory Affairs, CMC

    2 days ago

    Cambridge, United States Alnylam Full time

    This role is considered Hybrid. Responsibilities: The Associate Director, Regulatory Affairs CMC is responsible for helping to derive and implement the global regulatory CMC strategy for commercial programs. The Associate Director is a key member of multidisciplinary teams responsible for preparation of high-quality regulatory submissions focusing on...

  • Senior Director, Cell Therapy CMC/Process Development Lead

    2 weeks ago

    Cambridge, Massachusetts, United States Stratacuity Full time

    Job Overview: We are seeking a highly experienced Senior Director to lead our Cell Therapy Process Development and CMC efforts. This individual will be responsible for developing innovative, scalable expansion and differentiation processes to manufacture cell therapy products.Key Responsibilities:Provide strategic and technical CMC leadership for process...

  • Senior Director, Cell Therapy CMC/Process Development Lead

    1 week ago

    Cambridge, Massachusetts, United States Stratacuity Full time

    Job Overview:At Stratacuity, we are seeking a highly experienced Senior Director to lead our Cell Therapy CMC/Process Development team. As a key member of our organization, you will be responsible for developing innovative, scalable expansion and differentiation processes to manufacture cell therapy products.Primary Job Responsibilities:Provide strategic and...

  • Head of Sustainable CMC and Innovation

    2 weeks ago

    Cambridge, Massachusetts, United States Takeda Full time

    Job 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...

  • Head of Sustainable CMC and Innovation

    4 weeks ago

    Cambridge, Massachusetts, United States Takeda Pharmaceuticals Full time

    About 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...

  • Senior Director, Regulatory Affairs CMC

    2 weeks ago

    Cambridge, Massachusetts, United States Takeda Full time

    About 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...

  • Senior Director, Cell Therapy CMC/Process Development Lead

    3 weeks ago

    Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full time

    Job 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...

  • Senior Director, Cell Therapy CMC/Process Development Lead

    1 week ago

    Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full time

    Job Overview:Stratacuity seeks a Senior Director to lead process development, scale-up, optimization, and technical transfer of Cell Therapy Products. This role involves close collaboration with Contract Development and Manufacturing Organizations (CDMOs) for process development and manufacturing activities.Key Responsibilities:Provide strategic and...

  • Head of Sustainable CMC and Innovation

    1 week ago

    Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    About the Role:As 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 first" approach and ensure sustainability is embedded across all CMC activities, from...

  • Senior Director, Cell Therapy CMC/Process Development Lead

    2 weeks ago

    Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full time

    Job 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...

  • Associate Director, Regulatory Affairs CMC

    2 days ago

    Cambridge, United States Voyager Therapeutics, Inc. Full time

    The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in...

  • Director - GRA CMC, Small Molecules

    2 days ago

    Cambridge, United States Takeda Full time

    Job DescriptionAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as...

  • Associate Director Regulatory Affairs CMC

    3 weeks ago

    Cambridge, Massachusetts, United States Agios Pharmaceuticals Full time

    Associate 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...

Senior Director CMC Technical Innovation

2 months ago

cambridge, United States Proclinical Staffing Full time

Senior Director CMC Technical Innovation - Gene Therapies - Permanent - Massachusetts

Proclinical is seeking a Senior Director of CMC Technical Innovation to focus on Gene Therapy. This role requires a combination of CMC technical expertise (e.g. gene therapy, RNA, gene editing), effective communication, business and strategic acumen.

Primary Responsibilities:

This leader will drive technical innovation by both enhancing and leveraging our Technical Operations capabilities to maintain our position as a world leader and change driver in the industry. This role will collaborate with internal stakeholders, including but not limited to: Process Development, Analytical Development, Manufacturing, Supply Chain, Quality, R &D, Business Development, Legal (IP and contracts) and Finance, as well as external collaborators. Success in this role will be to advance Technical Operations' platform through new technology and internal inventions; technical presence through publications, conferences, collaborations and industry consortiums; and strategic opportunities identified through data analytics and sciences.

The Senior Director of CMC Technical Innovation's responsibilities will be:

  • Establishes formation of a centralized innovation framework, including creation and leadership of the strategy, forum, and process that drives implementation of new technology, and streamlines IP engagement
  • Expands the organization's Technical Operations presence through publications, speaking engagements participation in industry consortiums
  • Screens, analyzes and negotiates potential technical collaborations from a scientific, financial and strategic perspective
  • Drives identification and enablement of novel technologies and cross-functional Technical Operations improvements
  • Serves as the liaison to Technical Operations scientific and business teams to provide proposals to senior leadership and prioritizes innovation in alignment with the organizational and Technical Operations strategy
  • Demonstrates influential leadership capabilities and fosters a collaborative team environment
  • Leads organizational initiatives and represents Technical Operations on behalf of the organization
  • Participates in project related teams and other internal/external collaborations to support the client's objectives

Skills & Requirements:

  • Bachelor's degree in Life Sciences or Engineering with 15+ years of relevant experience with 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

If you are having difficulty in applying or if you have any questions, please contact Dominic Williams at d.williams@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.