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Manager, Quality Engineer

Philadelphia, PA

About the Position

The Manager, Quality Engineer will be responsible for supporting the development and implementation of quality standards and processes both internally and for Contract Development and Manufacturing Organization (CDMO) manufacturing operations. The position will report to the Sr. Director GMP Quality and be part of the Quality and Compliance team. The role will work in close collaboration with Process Development (PD), Analytical (AD), Regulatory, Quality Assurance, and other areas.

Responsibilities Include

  • Technical review of development and clinical manufacturing batch records, SOPs, deviations, and investigations
  • Provide technical support on viral vector usage in cell manufacturing process
  • Support projects involving the introduction and qualification of finished product and development of specifications
  • Analysis of manufacturing process data including statistical process control and trending, process performance and capability assessments, and revision of specifications.
  • Execute experiments in collaboration with PD/AD and other teams to support investigations and process improvements for clinical and commercial MFG
  • Conduct, review, and inform Risk Assessments and FMEAs related to analytical testing, manufacturing process changes, technical transfers, and facility fit activities
  • Proactively monitor manufacturing products Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs) using statistical analysis to maintain updated process definition and control strategies and to inform technical transfer, manufacturing, and regulatory activities
  • Evaluate process improvements to support cell product therapies during clinical, technical transfers, and commercial production
  • Provide necessary technical analysis to support analytical and manufacturing related investigations, ensuring compliance with internal standards and regulatory requirements
  • Perform technical diligence to contract development manufacturing sites with cross-functional teams
  • Support Regulatory submissions with technical content and expertise
  • Serve as a Quality subject matter expert in autologous cell therapy
  • Thoroughly understand the viral vector and cell manufacturing processes along with associated instruments and technologies to support issue resolution and ongoing manufacturing operations via hands on process work
  • Build strong relationships with stakeholder groups to create a culture of high performance

Required Qualifications

  • B.S., M.S. or Ph.D. in Biochemistry, Chemical/Biomedical Engineering or Biology/Immunology discipline or equivalent
  • 4+ years relevant industry experience with preference for previous MSAT, manufacturing, Quality or Process Development experience, and 2 years + direct experience developing, implementing, and executing quality risk management programs. Title to be commensurate with experience
  • Subject matter expert in cell therapy manufacturing and aseptic processing
  • General understanding of regulatory/compendial requirements used in cell therapy manufacturing
  • Experience with manufacturing process technical transfer, qualification, and validation
  • Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs
  • Ability to assess risk and develop contingency plans for process risks
  • Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities
  • Detail oriented with excellent verbal and written communication skills
  • Strong interpersonal and leadership skills to work with teams in different functions and organizations
  • Strong team orientation and passion for continuous self-development.
  • Experience with Quality Management System (Ex. Deviation, CAPA, Change Management)
  • Extensive knowledge of GMP manufacturing practices and documentation requirements
  • Technical experience working with CDMO for biopharmaceutical or cell therapy manufacturing, including collaborative engagement on investigations, technical diligence, and strategic initiatives.

Preferred Qualifications:

  • Experience writing and/or supporting protocols and testing.
  • Previous experience with CDMO supplier relationship management and performing technical diligence visits and/or supporting quality audits.
  • Understanding of key considerations for primary packaging of cell therapy products.
  • Familiarity with cell therapy supply chains and manufacturing methods.

How to Apply

Please email careers@cabalettabio.com directly to submit an application.

Please include your CV along with the title of the position you are applying for.

Benefits

Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Equal Opportunity Employer

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.