Sr. Manufacturing Associate, Cell Therapy cGMP/GMP (Woburn, MA)

October 11, 2021

Location: Woburn, MA, USA

Position Summary:

At Minovia, you will be a vital contributor to our inspiring, bold mission to aim for a cure for mitochondrial diseases through our Mitochondrial Augmentation Technology approach.  As a Sr. Manufacturing Associate, working on the Cell Therapy cGMP/GMP Manufacturing team, you will be empowered to support the manufacturing of Minovia’s Cell Therapy platform and work with cross-functional peers to support clean room activities and QC testing.  The primary focus of the Manufacturing Associate role will be cGMP cell therapy manufacturing as we set up our facility and processes in the US. This position will directly contribute to the successful delivery of novel cell therapies in support of human clinical trials.

This is a full-time position, reporting to Minovia’s Global Head of Manufacturing and Supply Chain, located in the US.  The successful candidate will be driven to thrive in an early-stage clinical biotech environment, be comfortable with ambiguity and will require flexibility in performing assigned tasks and skill sets across manufacturing and quality.  The successful candidate will be hands-on and operationally strong.

This is an outstanding opportunity to have a broad influence on the development and success of Minovia as it builds its cell therapy manufacturing capability in the US.

Responsibilities:

  • Execute unit operations for manufacturing of patient therapies according to standard operating procedures and cGMP, regulatory and safety requirements. Duties may include basic cell culture as well as specialized techniques for cell selection, activation, transduction, and purification
  • Perform all QC assays, including LAL endotoxin, sterility, etc
  • Perform operations in a cleanroom environment, using proper controls to assure aseptic processing; includes gowning, cleaning, and isolation procedures
  • Perform supporting operations as needed, including preparation of consumables, media blending, cleaning, and environmental monitoring
  • Complete all daily manufacturing tasks following standard operating procedures and batch document instructions, completing forms, reports, logs and records of equipment, and batches as required
  • Ensure all training assignments are complete and up to date, to maintain necessary technical skills and knowledge
  • Ensure processing equipment and required materials are available, maintained, and qualified as required for the different manufacturing activities
  • Support investigations in manufacturing and technical deviations
  • Actively participate in problem identification, problem solving, and change initiatives in cooperation with other teams and functions
  • Collaborate with process development scientist and the head of quality to get trained and transfer new processes into cGMP manufacturing

Requirements:

  • Associates degree in biotechnology, chemistry, pharmacy, engineering or related pharmaceutical science and 4-6 years relevant cGMP manufacturing and/or QC cell therapy experience
  • Previous hands-on experience in a cGMP or clinically regulated environment is critical
  • Proficiency in QC assays for drug product/release criteria
  • Proficiency in pipetting; ELISA assay experience required
  • Knowledge of aseptic processing in ISO 7 biosafety cabinets strongly preferred
  • Manufacturing experience in biopharmaceutical operations, preferably involving cell cultures or Regenerative Medicines
  • Experience with culture and handling of human primary cells

Knowledge and Skills:

  • Teamwork – Ability to work well in a highly cross-functional team environment
  • Communication – Able to expresses one’s self clearly and concisely within team; timely and effectively communicates issues to supervisor
  • Analytical and Problem-Solving Skills – Able to troubleshoot critical issues or problems and determine causes and possible solutions using appropriate information
  • Organization – Exercises good time management and prioritization skills and can successfully manage multiple tasks simultaneously
  • Motivated – Self-motivated and willing to accept temporary responsibilities outside of initial job description, understanding that priorities may change quickly in our dynamic, patient-centric business
  • Must be willing to travel domestically based on cell processing locations in the US 10-15% and potentially to Israel 1x per year

 

Contact: bethany@minoviatx.com – Bethany Sensenig, CFO and Head of US Operations

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