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Principal QC Scientist

Reference Number: 2514
Location: MA

Principal QC Scientist

Our client is an international biopharmaceutical company.  They have asked us to assist them in their search for a Principal QC Scientist.  The Principal QC Scientist provides expertise and technical leadership in all aspects of Quality Control oversight for company products manufactured at CMOs including, but not limited to, commercial products. This position develops strategic short-term and long-term approaches for complex method changes, process improvements, or product comparability assessments.  

The person chosen for this position must demonstrate sound scientific judgment and leadership in decision-making while keeping open communications with all relevant units, ensure that all work and deliverables are of high quality and apply corrective measures as needed, and possess excellent communication skills and ability to work across departments and boundaries.

Essential Functions/Responsibilities:
  • QC activities related to external API and DP manufacturing including in-process, release, and stability testing. 
  • Transfer of analytical test methods for in process and release tests in support of manufacturing at CMOs and/or testing at contract labs. 
  • Oversight of method validation at contract labs and CMOs. 
  • QC representation to tech transfer and CMC teams as needed. 
  • Prospective tracking and trending of analytical data from contract labs and CMOs 
  • Definition and review of product specifications and specification changes 
  • Drive the resolution of OOS and major laboratory investigations at contract labs and CMOs. 
  • Compose and/or review investigations reports, analytical method, batch analysis, and specification sections for regulatory submissions and performs proactive data trend analysis. 
  • Management of change control requests related to QC testing at contract labs and CMOs 
  • Reference standard and control maintenance at contract labs and CMOs 
  • External audits of contract labs and CMOs. 
  • Contribute to the relevant sections of regulatory submissions.
  We seek candidates with the following skills and experience:
  • Advanced degree in Chemistry, Biology, Biochemistry, or other related fields with >10 years of relevant Postdoctoral/Industrial experience. A Ph.D. degree is preferred due to the highly technical aspect of the core responsibilities and areas of oversight. 
  • Experience in development of pharmaceutical and protein therapeutics, team leadership, and regulatory filings and inspections. Direct experience in a Quality organization is strongly preferred.
  • Ability to work effectively and concurrently on multiple projects in a goal-oriented, timeline-driven, and growth-oriented dynamic work environment to provide accurate data to support contract manufacturing and supply chain. 
  • Excellent interpersonal and communication skills. 
  • Ability to define problems, collect relevant data, analyze data, establish facts and draw conclusions. Also assesses technical data for compliance with stated acceptance criteria and recommends solutions to complex technical problems relating to quality control related issues are required. 
  • Must be well-organized and self-motivated and possess an independent work style with the ability to initiate and follow through on goals, assignments, and project schedules. 
  • Thorough knowledge of regulatory guideline as well as ICH and other industry guidelines for pharmaceuticals and biologics is desired, especially related to drug product manufacturing. 
  • Ability to work on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors
  • Experience developing and administering budgets, schedules, and performance requirements. 
  • Frequent contact with internal personnel and outside customer representatives at various management levels concerning operations or scheduling of specific phases of projects or contracts.  Internal (25-50%): QC, QA, Supply Chain, Contract Manufacturing, Analytical Development, Process Development, Regulatory Affairs, Logistics;   External (50-75%): CMOs, Contract test labs. 
  • Limited travel, national and international, is required.
 

Do you have the skills and experience we seek and want to advance your career with a growing international company?  If so, please email your resume as a Word attachment with full contact information to us today.