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Genezen

Viral-vector and cell-therapy CDMO provider

Lead Engineer - Manufacturing Sciences & Technology

Bioprocess & BiomanufacturingPosted on Nov 10
Full-timeLexington, MA, USA$125k - $150k /yrIn-person

About the Job

Requirements

  • A BS, MS, or PhD degree in Engineering or another related scientific discipline is listed as essential.
  • At least 5 years of relevant experience in gene therapy or the biotechnology industry is required.
  • Experience in process development, especially upstream processes, and sterile GMP manufacturing for cell and gene therapy is required.
  • Experience developing and executing technology transfer from process development into GMP manufacturing is required.
  • Ability to drive process failure mode and effects analyses and risk assessments is required.
  • A good understanding of upstream processes for viral vectors, cell and gene therapy, or recombinant biologics is required.
  • Knowledge and experience of risk-based approaches to process development and validation are required.
  • Knowledge and experience in cell culture and cell and virus banking are required.
  • Ability to generate, manage, evaluate, and maintain critical data in an organized manner is required.
  • Experience with statistical analysis of process data, including control chart generation and trending, linear regression, and multivariate analysis, is required.
  • Strong written and oral communication at individual, team, and organizational levels is required.
  • Ability to manage multiple topics in parallel, meet strict timelines, and handle pressure is required.
  • A criminal background check is required.
  • Ability to regularly sit for long periods; frequently stand, sit, use hands to finger, handle, or feel, reach, and communicate by talking, hearing, telephone, and email; occasionally walk, climb or balance, and stoop, kneel, crouch, or crawl; frequently lift or move up to 10 pounds and occasionally lift or move up to 25 pounds; and frequently use close vision and adjust focus is required.

Responsibilities

  • Lead technology transfer to GMP manufacturing by drafting and reviewing process description documents and technology transfer reports, reviewing master batch records and protocols, and providing on-floor support for transfer operations.
  • Provide manufacturing technical support, including process troubleshooting, root cause analysis, and investigation of process or quality discrepancies and deviations during GMP production, change controls, and corrective and preventive actions.
  • Support planning and execution of process and product lifecycle management, including continuous upstream process improvement to improve robustness, capacity, productivity, and compliance.
  • Collaborate cross-functionally with Process Development, Manufacturing, Quality Control, Quality Assurance, Engineering, Validation, and Supply Chain as needed.
  • Lead process validation campaigns to develop a thorough understanding of operating and performance parameters.

Desired Qualifications

  • Experience working in the contract development and manufacturing organization (CDMO) space is desired.
  • Knowledge of current pharmaceutical, regulatory, and technology trends is desired.
  • Knowledge of data management tools and statistical process controls is desired.
  • Understanding of downstream processes for viral vectors, cell and gene therapy, or recombinant biologics is desired.

About the Company

Genezen

Viral-vector and cell-therapy CDMO provider

Genezen is a contract development and manufacturing organization (CDMO) focused on gene and cell therapies, specializing in viral vectors and transduced cells. It provides end-to-end, fee-for-service development and cGMP manufacturing, from early development through clinical-grade vector production for trials. The company differentiates itself by offering a global, single-partner solution that covers the entire viral vector and cell-therapy pipeline. Its goal is to help clients advance gene and cell therapy programs by delivering reliable development, manufacturing, and testing support toward clinical trials.

Company size
201-500
Company stage
Growth Equity (Venture Capital)
Total funding
$18.5M
Headquarters
Lexington, MA
Founded
2014

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