GMP Manufacturing Associate, Clinical Materials (MA)

Job Description
Semma Therapeutics is a biotechnology company pioneering the development of a stem cell-based cure for diabetes. We are seeking an outstanding manufacturing associate for clinical materials to join our growing team. This full-time role reports to the Director of Manufacturing, and will be responsible for the technology transfer and production of cell therapy products to support Semma’s Phase I/II clinical trials. Clinical materials produced in the facility will be manufactured according to Good Manufacturing Practices (GMP) and conducted under Investigational New Drug (IND) applications with the US Food and Drug Administration (FDA).

Responsibilities:

  • Perform product manufacturing for clinical materials according to cGMP standards. Includes assembling raw materials, following specific standard operating procedures (SOP), aseptic technique, completing batch records, reporting deviations. Participates and facilitates technology transfer and final process development from the Research to the Manufacturing group. Assists in the development of Standard Operating Procedures (SOPs) for manufacturing in collaboration with Research and Quality Systems groups
  • Ensures raw materials are identified and available in time for manufacturing activities
  • Participates in clinical materials production activities and completes production batch records
  • Supports Operations group to ensure proper coordination of resources
  • Ensures cGMP compliance through manufacturing oversight and tracking
  • Other duties and projects as assign as required to meet departmental requirements

Required qualifications:

  • Bachelor’s degree in Biological, Bioengineering, Chemical Engineering or process related sciences required. Some cell culture experience required. Experience with iPSC cells and their derivatives preferred.
  • Prefer prior GMP manufacturing experience
  • Expertise in cell processing and culture technologies for clinical materials production required

Preferred qualifications:

  • Advanced degree
  • At least 6 months working in process development and/or manufacturing of cell therapy products preferred
  • Experience with 3-15 liter scale perfusion bioreactors for cell culture preferred
  • Knowledge of federal requirements for GMP manufacturing (21CFR 210,211) and Quality Systems (21CFR 820)
  • Experience with embryonic or induced pluripotent stem cell culture
  • Experience with bioreactor-based cell culture

Please note that applicants should have authorization to work in the United States. Semma offers competitive pay, health insurance, time-off among other benefits. Please, fill out the form below and include your resume.

.

Submit Your Resume


Name:*
E-mail:*
Phone:*
-
Job Title:
Cover Letter:
Upload Resume:
Security Check: