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Process Development Scientist

JOB ID: 2018MSTOPDS

POSTED: 04/16/2018

 

Job Detail

Tmunity is seeking a talented scientist to expand our Process Development Team. The Process Development Scientist will perform studies to develop and optimize the manufacturing process of gene-modified cellular products to support the company’s development programs.

Responsibilities

 

  • Collaborate closely with the University of Pennsylvania and other partner institutions to transition process development activities to Tmunity Labs and to conduct ongoing joint development activities.

  • Perform development studies including optimization of cell isolation, cell culture, cell transduction and cell cryopreservation processes.

  • Evaluate raw materials and develop proper analytical controls to screen and select those that are critical to the manufacturing process.

  • Evaluate innovative manufacturing & analytical technologies for engineered T cell manufacturing to improve process efficiency

  • Author technical and scientific documents including but not limited to SOPs, Master Batch Records, study protocols and reports.

  • Prepare protocols and reports for qualification and validation of manufacturing processes and equipment.

  • Working with the integrated program team, contribute to the creation of company IND enabling activities.

  • Participate in the preparation of CMC documents for regulatory filings

  • Other activities as assigned.

  • Will require some weekend and off-hours work.

Basic Qualifications

  • BS / MS in Immunology, Cell Biology, Bio-Engineering or a related field.

  • 5+ years of life sciences development experience; 2+ years’ experience in cell therapy product / process development strongly preferred.

  • Hands-on experience with primary cell culture and cell processing methods.

  • Experience with technology transfer, manufacturing process scale-up, equipment qualification, and process validation activities.

  • Strong record keeping skills; excellent oral and written communication skills.

  • Comfortable in a fast-paced small company environment, working with minimal direction and able to adjust workload based upon changing priorities

Preferred Qualifications

  • Knowledge of cGMP Quality Systems

  • Experience with flow cytometry and T cell phenotyping

  • Familiarity with statistical software applications (e.g. Minitab, JMP)

 

Location

  • Fulltime, based in East Norriton, PA

  • Will require periodic travel to the Tmunity offices and the University of Pennsylvania facilities in Philadelphia

Tmunity is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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Tmunity Therapeutics Inc.
3020 Market Street, Suite 535
Philadelphia, PA 19104

+1 215 966 1600

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