About Us

Thymmune Therapeutics is a cutting-edge biotechnology company focused on advancing innovative immunotherapies to treat a variety of diseases. Our mission is to harness the power of thymic epithelial cells (TECs) derived from induced pluripotent stem cells (iPSCs) to develop novel immune-based therapies. As we grow and expand our capabilities, we are seeking a highly motivated and skilled Analytical Development Scientist to join our team.

Role Description

The Analytical Development Scientist will play a critical role in advancing the development of our immunotherapeutic products by leading analytical testing, characterization, and analytical development studies. This position involves developing and validating assays to evaluate the quality, potency, and stability of iPSC-derived Thymic Epithelial Cell products and collaborating with cross-functional teams to ensure successful drug substance and drug product development.

Key Responsibilities:

Execute a variety of analytical methods, including cell-based assays, ELISAs, dPCR and flow cytometry, to characterize iPSC-derived iPSC-derived Thymic Epithelial Cells (TECs) and related drug products
Lead and execute in-depth characterization studies of drug products to fully understand the characteristics and potency of drug product
Analyze and interpret complex data, generating detailed reports to guide product development and regulatory filings
Maintain detailed documentation of all experimental work, supporting information, and data in an electronic lab notebook in a timely and accurate manner
Act as a Subject Matter Expert (SME) in the transfer of analytical methods, protocols, procedures, and know-how from internal labs to external labs
Provide technical support to troubleshoot QC testing issues during clinical production at CDMOs. Provide person-in-plant support, as needed
Compile, present, and interpret data in collaboration with cross-functional teams, and assist in authoring and reviewing method development reports, test methods, SOPs, and supporting documentation
Work closely with the R&D, Process Development, and other internal teams to ensure smooth workflow and the alignment of analytical development with product development goals
Cross-train and mentor research associates on various assays, providing guidance and training as needed
This is a hands-on laboratory-based position, requiring direct involvement in the execution of experiments and the optimization of analytical methods

Qualifications:

Education: Bachelors/Master’s degree in Immunology, Cell Biology, Biotechnology, or a related field is required. Advanced Degree (Ph.D.) is preferred
Experience: PhD with 0-2 years; MS with 3-5 years; BS with 5-7 years of relevant industry experience is required
Proven experience in analytical method development and validation, preferably within cell-based therapies or biologics
Strong expertise in qPCR, flow cytometry, potency assays, and other cell-based analytical techniques
Experience in process characterization, formulation studies, and stability testing
Familiarity with regulatory guidelines (FDA, EMA) related to cell therapy and biologics
Excellent problem-solving skills, with the ability to analyze complex data and provide actionable insights
Strong communication skills, both written and verbal, with the ability to interact effectively with cross-functional teams
Ability to work independently, manage multiple projects simultaneously, and meet deadlines in a fast-paced environment

Preferred Qualifications:

Experience working with iPSC-derived products or stem cell technologies
Knowledge of GMP or GLP regulations in a laboratory setting
Experience in training and mentoring junior scientists and research associates

Thymmune Therapeutics

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