Director/Sr. Director, Analytical Development & Quality Control

Andover Permanent USD200,000 - USD240,000
  • Join a biotech company with an advancing portfolio in viral immunotherapies
  • Exciting opportunity to join a fast growing company

About Our Client

Clinical-stage biotechnology company focused on developing next-generation viral immunotherapies to transform patient lives.

Job Description

  • Grows the analytical and quality departments by attracting, training, engaging, and retaining talent.
  • Leverage regulatory guidance and Quality-by-Design
  • Evaluates production operations from a strategic level
  • Collaborates with management and senior staff across production departments
  • Selects, develops, and qualifies phase-appropriate test methods for the characterization of HSV and Synthetic oncolytic viruses
  • Responsible for environmental monitoring program for GMP manufacturing
  • Collaborates with purchasing manager to ensure raw materials from external suppliers meet quality requirements
  • Assesses test results and approve recommended changes
  • Reviews quality control documentation such as SOPs, logs, and reports for effectiveness, accuracy, and relevance
  • Authors SOPs, method and instrument qualification protocols, reports, certificates of analysis, and CMC sections of regulatory filings
  • Serves as a subject matter expert and aiding in the investigation of out of specification or out of trend analytical results
  • Interfaces with contract research organizations (CROs) and collaborators to lead method transfer and method qualification activities

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

  • Bachelor's degree with +15 years relevant experience or Master's/PhD degree with +10 years relevant experience in analytical development and/or quality control of biologics, viral products, gene therapy, RNA or lipid nanoparticle (LNP) products
  • A strong background in characterization of biologics, viral products, RNA, LNPs or gene therapy products, including chromatographic, electrophoretic, spectroscopic, and biophysical characterization techniques
  • Thorough understanding of quality control standards and methodologies
  • Thorough understanding of biologics or gene therapy manufacturing, testing, and production in industry
  • Deep understanding of analytical methods required for development and characterization of viral products
  • Experience transferring methods and managing relationships with CROs or CMOs

What's on Offer

  • Offers a comprehensive benefits package including health, dental, life insurance, 401k, unlimited vacation and much more.
  • Job Type: Full-time
  • Travel: Minimal
  • Salary: commensurate with role and experience
Meghan Landry
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Job summary

Life Sciences
Sub Sector
Healthcare / Pharmaceutical
Contract Type
Consultant name
Meghan Landry
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