Associate Director/Director, Analytical Development
1 month ago
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 an Associate Director/Director of Analytical Development to join our rapidly growing CMC team.
The Associate Director/Director of Analytical Development will be leading the Company’s analytical development strategy to support Thymmune's iPSC derived cell therapy pipeline. You will define and execute analytical development and method transfer activities to enable iPSC expansion and differentiation in GMP manufacturing throughout the product lifecycle. This position requires broad technical experience in analytical development and must have expertise in characterizing cell therapy products. Your work will be instrumental in ensuring the safety, efficacy, and quality of our cell therapy products.
The Associate Director/Director, Analytical Development will be responsible for leading the characterization of drug substances and drug product, developing analytical assays for release and stability testing, setting specifications, and ensuring methods are robust, reliable, and fit-for-purpose. They will also work with external CDMOs and Contract Testing Labs (CTLs) to provide technical oversight for method transfer and method qualification activities.
The 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
- Lead analytical development strategy and develop phase-appropriate and risk-based analytical assays and potency testing strategies to support Thymmune’s pipeline of iPSC derived cell therapy products.
- Author and review SOPs, test methods, technical reports, and supporting procedures for analytical method development and qualification in support of process development and GMP manufacturing.
- Support due diligence activities for selection of CDMOs and Contract Testing Labs (CTLs).
- Act as an SME for analytical development and be responsible for knowledge/technology transfer of in-process, release, and product characterization methods to the CDMOs/CTLs.
- Provide technical support to troubleshoot QC testing issues during clinical production at CDMOs. Provide person-in-plant support, as needed.
- Recruit, manage, train, motivate, develop, and mentor Analytical Development staff. Execute analytical development work and perform assays in laboratory setting, as necessary.
- Collaborate closely with colleagues across different functions to best leverage internal and/or external capabilities to assist in analytical development effort.
- Present technical data to cross functional teams and senior management as an analytical development expert, and effectively communicate critical analytical issues and solutions.
- Develop, review, and approve analytical development source documents, and author and review relevant 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 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 8 years of experience or BS/MS with over 10 years of relevant experience. In addition, 2-5 years of supervisory experience.
- Technical expertise in cell therapy analytical methods, such as potency assays, flow cytometry-based assays, and product characterization assays.
- Experience in analytical method development, optimization, qualification, and transfer, in accordance with regulatory guidelines and industry standards.
- Hands-on experience in characterization of cell therapy products, flow cytometry, RT-PCR, genomic sequencing methodologies, and single cell analysis.
- Working knowledge of safety assays required for lot release such as endotoxin, mycoplasma, and sterility, including rapid release tests.
- Expertise in analytical control strategies including specification setting.
- Experience in setting and managing stability studies per ICH guidelines and establishing shelf life for drug substance and drug product.
- Experience with cell-based potency assay development and defining potency testing strategy for cell therapy products.
- Experience establishing and managing interactions with CDMOs and CTLs.
- In-depth understanding of regulatory guidelines and experience with CMC regulatory filings.
- Excellent communication, technical writing, and presentation skills
- Exceptional teamwork and interpersonal skills with the ability to motivate others, influence, and negotiate difficult situations.
- Strong attention to detail and demonstrated ability to collaborate effectively on cross-functional teams and within a dynamic environment.
- Excellent analytical and problem-solving skills, with a strong ability to troubleshoot critical issues or problems.
- Ability to balance/prioritize efforts across multiple programs, meet deadlines, and shift plans in service of a rapidly changing startup environment.
- Hands-on, roll-up-your-sleeves approach with high sense of urgency and rive for results.
Preferred
- Knowledge and experience in developing and qualifying analytical methods for iPSC derived cell therapy products
- Experience with new advances in analytics such as real time monitoring technologies, RNA PrimeFlow, digital PCR, spatial transcriptomics, etc.
- Understanding of stem cell therapy characteristics and critical attributes
- Experience with bioinformatics is nice to have
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