Director of Process Development

20 hours ago

Cambridge, Massachusetts, United States Thymmune Therapeutics Full time
About Us

Thymmune 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 with leading labs to drive cutting-edge research and development. Our team is backed by early investors and founders of successful high-profile biotechnology companies, providing a solid foundation for growth and success.

Job Description

We are seeking a highly skilled and experienced Director, Process Development to join our rapidly growing CMC team. As a key member of our organization, you will lead and empower a high-performing process development team to develop scalable manufacturing processes for our iPSC-derived cell therapy pipeline.

Your primary responsibilities will include defining and executing process development and tech transfer activities to enable iPSC expansion and differentiation in GMP manufacturing throughout the product lifecycle. You will work closely with external CDMOs to provide technical oversight for process development and manufacturing activities.

The ideal candidate will possess a strong understanding of GMP processes, process design for drug substance and drug product, scale-up, control strategy, GMP facility readiness, and risk assessments. You will contribute to overall CMC strategy development and partner with CMC leadership to align CMC development plans with overall project plans.

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, including 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 and provide person-in-plant support as needed.
  • Recruit, manage, train, motivate, develop, and mentor Process Development staff, supporting 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 efforts.
  • Present technical data to cross-functional teams and senior management as a process development expert, effectively communicating critical process issues and solutions.
  • Develop, review, and approve process development source documents, author and review CMC sections for regulatory submissions, and 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

We are seeking a highly qualified candidate with the following qualifications:

  • 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, plus 5+ years of supervisory experience.
  • Deep expertise and industry experience in cell therapy process development principles, 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 a high sense of urgency and drive for results.
Preferred Qualifications
  • 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.
Location

Cambridge, MA / Hybrid (Partially work from home)

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