Current jobs related to Director, Process Development - Cambridge - Thymmune Therapeutics

  • Director of Process Development

    1 month ago

    Cambridge, Massachusetts, United States Thymmune Therapeutics Full time

    About Thymmune TherapeuticsThymmune Therapeutics is a preclinical biotechnology company based in Cambridge, MA, dedicated to developing and commercializing innovative iPSC-derived immune cell therapy products addressing significant opportunities with unmet clinical need across immunology.Job DescriptionWe are seeking a highly skilled Director of Process...

  • Director of Process Development

    4 weeks ago

    Cambridge, Massachusetts, United States Thymmune Therapeutics Full time

    About UsThymmune Therapeutics is a pioneering biotechnology company based in Cambridge, MA, dedicated to harnessing the power of thymic engineering to develop and commercialize innovative iPSC-derived immune cell therapy products addressing significant unmet clinical needs across immunology.We are committed to building a strong foundation for our rapidly...

  • Associate Director of Process Development

    2 weeks ago

    Cambridge, Massachusetts, United States Vor Bio Full time

    Unlocking Cancer Treatment through Innovative ScienceVor Bio is seeking an Associate Director/ Director of Process Development to join our Process and Analytical Development group. As a key member of our team, you will oversee the design, development, and characterization of gene edited hematopoietic stem cells (eHSC) and CAR-T manufacturing processes to...

  • Director of Process Development

    2 weeks ago

    Cambridge, Massachusetts, United States Thymmune Therapeutics Full time

    About UsThymmune Therapeutics is a preclinical biotechnology company based in Cambridge, MA, applying proprietary insights in thymic engineering to develop and commercialize iPSC-derived immune cell therapy products addressing significant opportunities with unmet clinical need across immunology.Role DescriptionWe are seeking a highly skilled Director,...

  • Director of Process Development

    3 weeks ago

    Cambridge, Massachusetts, United States Thymmune Therapeutics Full time

    About UsThymmune Therapeutics is a pioneering biotechnology company based in Cambridge, MA, dedicated to harnessing the power of thymic engineering to develop and commercialize innovative iPSC-derived immune cell therapy products addressing significant unmet clinical needs across immunology.We are committed to building a strong IP position and collaborating...

  • Director of Upstream Process Development

    2 weeks ago

    Cambridge, United States EPM Scientific Full time

    Job DescriptionJob DescriptionDirector of Upstream Process Development Job Summary:The Director of Upstream Process Development will lead the design, optimization, and scale-up of upstream processes for biologics production, focusing on cell culture and fermentation technologies. The position will be pivotal in developing robust, scalable, and cost-efficient...

  • Associate Director, Downstream Process Development

    4 weeks ago

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

    Job Title: Associate Director, Downstream Process DevelopmentStratacuity is seeking an experienced Associate Director to lead our Downstream Process Development team. As a key member of our organization, you will be responsible for developing and optimizing downstream processes for protein therapeutics.Key Responsibilities:Develop and optimize downstream...

  • Director of Downstream Process Development

    4 weeks ago

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

    Job Title: Associate Director, Downstream Process DevelopmentLocation: Cambridge, MA (Onsite)Science: Protein TherapeuticsJob Overview:This hands-on leader will operate in a cross-functional leadership role to facilitate the development and technology transfer efforts of protein therapeutics to external CDMOs.Key Responsibilities:Develop and optimize...

  • Director, Process Development Lead

    1 month ago

    Cambridge, Massachusetts, United States Arbor Biotechnologies Full time

    About The Role:As the Director, Process Development, you will report to the VP of CMC and provide strategic leadership to develop, establish, and drive the execution of the organization.You will develop scalable manufacturing processes to support Arbor's gene editing pipeline.You will define and execute process development and tech transfer activities to...

  • Senior Director, Cell Therapy CMC/Process Development Lead

    2 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...

  • Senior Director, Cell Therapy CMC/Process Development Lead

    1 week 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

    6 days 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...

  • 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 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

    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...

  • Senior Director, Cell Therapy CMC/Process Development Lead

    6 days 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...

  • Development Director

    2 weeks ago

    Cambridge, Massachusetts, United States Harvard University Full time

    Job SummaryHarvard University is seeking a seasoned Development Director to lead a high-performing team of fundraising professionals in the Faculty of Arts and Sciences. As a key member of the Alumni Affairs and Development team, you will be responsible for developing and executing strategic plans to secure major gifts from alumni, parents, and friends of...

  • Senior Director, Cell Therapy CMC/ Process Development

    2 weeks ago

    Cambridge, United States Apex Systems Full time

    Job#: 2049643 Job Description: Senior Director, Cell Therapy CMC/ Process Development 2049643Location: Cambridge, MA (Onsite / Hybrid)Job Overview: Lead process development, process scale-up, optimization, and technical transfer of Cell Therapy Products working closely with CDMOs for process development and manufacturing activities.Primary Job...

  • Senior Research Associate

    2 weeks ago

    Cambridge, Massachusetts, United States Takeda Development Center Americas, Inc Full time

    Job Title: Senior Research AssociateTakeda Development Center Americas, Inc. is seeking a highly skilled Senior Research Associate to join our team in Cambridge, MA.Job Summary:We are looking for a talented individual to develop and optimize downstream processes for viral vector production, including purification and filtration. The ideal candidate will have...

  • Senior Director of Development

    2 weeks ago

    Cambridge, Massachusetts, United States Harvard University Full time

    Job Title: Senior Director of DevelopmentHarvard University is seeking a seasoned fundraising leader to serve as the lead strategist in formulating and executing plans to advance fundraising priorities for the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS).About the RoleThis senior fundraising leader will partner with major and...

  • Business Development Director

    2 weeks ago

    Cambridge, Massachusetts, United States Talent Masters Full time

    Job Title: Director of Business DevelopmentTalent Masters is seeking a seasoned Director of Business Development to lead our skilled nursing liaison team in Maryland. As a key member of our organization, you will drive growth and increase patient census across multiple skilled nursing facilities.Key Responsibilities:Develop and implement strategies to boost...

Director, Process Development

3 months ago

Cambridge, United States Thymmune Therapeutics Full time
Job DescriptionJob DescriptionAbout Us

Thymmune Therapeutics is a preclinical biotechnology company based in Cambridge, MA applying proprietary insights in thymic engineering to develop and commercialize iPSC derived immune cell therapy products addressing significant opportunities with unmet clinical need across immunology. Building on work from leading labs, Thymmune has strong IP positioning and is backed by early investors and founders of successful high-profile biotechnology companies.

Role Description

Our innovation and value-driven organization is seeking to hire a Director, Process Development to join our rapidly growing CMC team. You will build and lead a high performing process development team to develop scalable manufacturing processes to support Thymmune’s iPSC derived cell therapy pipeline. You will define and execute process development and tech transfer activities to enable iPSC expansion and differentiation in GMP manufacturing throughout the product lifecycle. This position requires broad technical experience in cell culture and must have expertise in human pluripotent stem cell culture and differentiation or in scale-up of allogeneic cell therapies.

The Director, Process Development will be responsible for leading and empowering the Process Development Team for process development, formulation development, process scale-up, optimization, and technical transfer of the Company’s product candidates. They will also work with external CDMOs to provide technical oversight for process development and manufacturing activities.

They should be detail oriented and have strong understanding and technical knowledge of GMP processes, process design for drug substance and drug product, scale-up, control strategy, GMP facility readiness (equipment, raw material, documents, etc.) and risk assessments. They will contribute to overall CMC strategy development and partner with CMC leadership to align CMC development plans with overall project plans. 

A successful candidate will be a self-starter, always up for a challenge and someone who finds the unique demands of the fast-paced startup environment motivating. 

Key Responsibilities
  • Provide strategic and technical CMC leadership for developing innovative, scalable expansion and differentiation processes to manufacture iPSC derived cell therapy products.
  • Lead process development strategy for the Company’s products and ensure processes are suitable for the phase of development. This includes process design and development, scale-up and optimization, characterization, and control strategy development.
  • Support due diligence activities for selection of CDMOs and capacity planning for clinical/commercial manufacturing.
  • Lead activities required to ensure successful transfer and execution of expansion and differentiation processes in GMP manufacturing, including technical oversight of external CDMOs.
  • Provide technical support to troubleshoot manufacturing issues during clinical production at CDMOs. Provide person-in-plant support, as needed
  • Recruit, manage, train, motivate, develop, and mention Process Development staff.  Support process development work in laboratory settings, as necessary.
  • Collaborate closely with colleagues across different functions to best leverage internal and/or external capabilities to assist in process development effort.
  • Present technical data to cross functional teams and senior management as a process development expert, and effectively communicate critical process issues and solutions.
  • Develop, review, and approve process development source documents, and author and review CMC sections for regulatory submissions. Support the Regulatory group in responding to agency questions.
  • Ensure the team stays up to date with current technologies and manufacturing trends focusing on continuous improvement and operational excellence.
  • Support the team budget and the planning of capital requirements.
Qualifications and Experience

Required
  •  PhD in biological sciences, immunology, cell biology, biomedical or biochemical engineering with over 10 years of experience or BS/MS with over 15 years of relevant experience. In addition, 5+ years of supervisory experience.
  • Deep expertise and industry experience in cell therapy process development principals including control strategy development.
  • Experience with current technologies in iPSC process development and manufacturing, particularly scalable stem cell culture systems such as bioreactors.
  • Experience in cell line development, cell banking, and characterization.
  • Expertise in design of experiments, data analysis, and data interpretation for process development studies.
  • Direct experience working with CDMOs and supporting tech transfer and/or GMP clinical manufacturing operations.
  • Excellent problem-solving skills, with a strong ability to troubleshoot critical issues or problems.
  • Expert understanding of ICH and FDA guidelines and the ability to apply these guidelines in context of the stage of drug development.
  • Experience supporting regulatory filings and interaction.
  • Strategic thinking and planning ability.
  • Demonstrated collaborative leadership, strong people skills, and excellent verbal and written communication skills.
  • Demonstrated ability to work successfully in a fast-paced team/matrix environment as well as independently manage priorities and maintain timelines for multiple activities.
  • Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for result.
Preferred
  • Experience in the characterization of pluripotent stem cells, flow cytometry, RT-PCR, and genomic sequencing methodologies.
  • Experience in formulation development as well as process development associated with drug product unit operations such as cryopreservation and fill-finish.

 

Powered by JazzHR

1mvBuYMfJr