1-617-500-6690 [email protected]

Company:  Confidential

Job Title: Associate Director of Quality Control, mRNA & LNP-mRNA

Job Number: 31420

Location: Burlington, VT

Job Description

Summary

The Associate Director of Quality Control will build and lead a team of analytical scientists to develop and validate a suite of platform analytical methods for receipt testing of raw materials, and in-process and release testing of pDNA, mRNA and lipid nanoparticle formulated mRNA.

The incumbent will oversee lab operations by supervising methods development and set priorities to rapidly achieve success across several test panels.  Success will depend on previous experience in regulatory matters associated with methods validations, filings, and investigations, stability studies, facility management (e.g. metrology strategy), and subject matter expertise in complex analytical methods (e.g. cell-based potency assays, LC-MS, qPCR, or NGS).   Importantly, the incumbent will partner with Research, Technical Operations, Quality Assurance, and Regulatory to set an efficient QC strategy and to maximize transparency and reporting. 

Responsibilities

Responsibilities

  • Staff and supervise QC laboratory responsible for testing raw materials, intermediates, pDNA, mRNA drug substance, and LNP-mRNA
  • Plan and initiate development of all analytical methods and reference materials
  • Operate within a Quality by Design framework for analytical methods by developing risk management plans
  • Manage the optimization, qualification, and validation of analytical methods for the characterization of pDNA, mRNA, LNP-mRNA, nucleotides, and proteins
  • Ensure that analytical methods are maintained in a state of validation that is fit for use and that supply chain of critical reagents and supplies, including reference standard materials is maintained
  • Develop and apply statistical methods as needed 
  • Ensure that all plans and work is documented in electronic lab notebooks, QbD system, document control system, LIMS, or other cGMP systems 
  • Draft regulatory filings, author QMS records (e.g. deviations, change control, CAPAs)
  • Manage routine testing of raw materials, in-process intermediates, finished products, and stability
  • Recognize, report, and investigate out-of-specification or unexpected results 
  • Cultivate a culture of shared success

Required Skills

Desired skills and background

  • Masters or Ph.D. degree in cell or molecular biology, biomedical or chemical engineering, biochemistry, or a related field
  • 7-15 years in cGMP QC environment with significant regulatory documentation experience
  • In-depth knowledge of relevant FDA, EU, ICH guidelines and regulations
  • Expertise in either nucleic acid chemistry, pDNA, mRNA, or LNP analytical technologies such as capillary electrophoresis, LC/MS, next generation sequencing, qPCR, or gel electrophoresis
  • Method optimization through design of experiments and proficiency in statistical data analysis
  • Project management skills, including scheduling and reporting
  • Demonstrated proficiency with Quality System Records
  • High attention to detail including planning, executing, and documenting experiments
  • Communication skills including protocol writing, working directly with clients, Power Point

 

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