Verista, Inc.-posted 2 days ago
$85,000 - $150,000/Yr
Full-time • Mid Level
Berkeley, CA
501-1,000 employees

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise The Cell & Gene Therapy SME / Lead Process Engineer will serve as the subject matter expert (SME) for process validation and regulatory compliance in cell and gene therapy manufacturing. This role ensures that all processes meet global regulatory standards and are validated for consistency, safety, and efficacy.

  • Lead end-to-end process validation activities for cell and gene therapy manufacturing, including qualification of equipment, cleaning, and analytical methods
  • Develop and execute validation protocols (IQ/OQ/PQ) and maintain validation master plans for cell & gene therapy processes
  • Ensure compliance with FDA, EMA, and ICH guidelines, as well as cGMP/cGTP requirements
  • Review regulatory documentation for IND, BLA, and other submissions and provide recommendations for requirements on highly manual processes
  • Monitor changes in global regulatory requirements and implement updates in SOPs and cell therapy processes
  • Provide cell therapy technical expertise during risk assessments and CAPA implementation
  • Train cross-functional teams on cell therapy validation and compliance best practices
  • Support technology transfer and scale-up activities with a focus on regulatory alignment
  • Bachelor’s or Master’s degree in Biotechnology, Pharmaceutical Sciences, or related field
  • 5+ years of experience in process validation within cell/gene therapy or biologics manufacturing
  • In-depth knowledge of cGMP/cGTP, FDA, EMA, and ICH regulatory frameworks
  • Strong experience with validation protocols, regulatory submissions, and audit readiness
  • Excellent communication and leadership skills to influence cross-functional teams
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance.
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Supplemental Life, Hospital, Critical Illness and Legal Insurance
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • As Needed Sick Time
  • Tuition Reimbursement
  • Team Social Activities (We have fun!)
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement
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