Sr. RA, Analytical Development

Company : Thymmune Therapeutics

Job Description - Sr. RA, Analytical Development

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 Sr. Research Associate to join our team.

Role Description
The Analytical Development Sr. Research Associate will play a critical role in advancing the development of our immunotherapeutic products by doing 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/functionality, ELISAs, qPCR/ddPCR and flow cytometry, to characterize iPSC-derived Thymic Epithelial Progenitor Cells (TEPs) and related drug products.

Maintain detailed documentation of all experimental work, supporting information, and data in an electronic lab notebook in a timely and accurate manner.
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.
Perform process development experiments, 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:

B.Sc. + 4 years or Master’s degree + 0-1 years in Immunology, Cell Biology, Biotechnology, or a related field with relevant industry experience.
Proven experience in analytical method development preferably within cell-based therapies or biologics.
Experience with qPCR/ddPCR, flow cytometry, potency assays, and other cell-based analytical techniques.
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 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.

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Sr. RA, Analytical Development

Job Description - Sr. RA, Analytical Development

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