Athersys
Published
09/29/2021
Location
3201 Carnegie Avenue, Cleveland
Category
Job Type
Contact Name
Peg Glover

Description

AT ATHERSYS:  Our people make the difference.  We owe our success to the passionate, driven and growth-oriented people who have chosen to align their careers with our mission, “Committed to developing therapies to extend and enhance the quality of human life.”

WE ARE SEEKING:  A MS&T Process Engineer to join our team. The MS&T Process Engineer is a part of a team that will lead the design and launch of our next generation manufacturing process.  This individual will evaluate, develop, and qualify new technology/equipment and materials for cell therapy manufacturing and will work with team members across process development, quality, facilities, and supply chain to ensure the successful launch of the facility. Work closely with process characterization teams to assure process reliability and robustness in preparation for comparability and process validation. Participate in evaluation of new technology, single-use materials qualification, and process automation for introduction into GMP manufacturing.

SUMMARY:

  • Lead process FMEAs to understand process and product risks as a pre-requisite for process validation
  • Collaborates with internal stakeholders and external vendors and suppliers to support materials changes, secondary source qualification and define requirements and understand functional specifications
  • Support investigations, identify root cause for critical deviations during process validation and determine CAPA for manufacturing
  • Ensure technical documentation is written and/or edited in a timely manner (SOPs, protocols & reports for FATs, SATs, IQ/OQ/PQ testing, comparability, aseptic process simulation and cell therapy manufacturing process validation testing)
  • Participate and report to a cross-functional development team to advance production activities
  • Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues
  • Participate in evaluation of new technology, materials and process automation for introduction into GMP manufacturing

EDUCATION/EXPERIENCE: 

  • Bachelor’s Degree in the life sciences, chemical/biomedical engineering or a related field of study preferred
  • 3 to 5 years of relevant pharmaceutical manufacturing, technology transfer & process development experience including mammalian cell culture (human stem cells preferred)

KNOWLEDGE/SKILLS:

  • Practical expertise with cGMP manufacturing and regulatory requirements for biologics, biopharmaceuticals and/or medical devices
  • Mastery of scientific and engineering principles
  • Knowledge of validation principles for equipment (IQ/ OQ/PQ), including automation compliance to 21CFR Part 11/ EMA Annex 11 requirements
  • Knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products and process development
  • Ability to think critically, and demonstrated troubleshooting and problem-solving skills
  • Excellent interpersonal, verbal, and written communication skills
  • Ability to function efficiently and independently in a changing environment
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description
  • Well-developed computer skills

Athersys is an equal opportunity employer. Qualified applicants are considered for all positions without regard to age, race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other status protected by applicable law.

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