DIRECTOR, PROCESS DEVELOPMENT

About 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 Thymmunes 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 Companys 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 Companys 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.

Location

Cambridge, MA / Hybrid (Partially work from home)