Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. The variety of clients and issues that we support give our team and our organization an ever-increasing breadth of experience to add to our deep industry and functional expertise. Headquartered in the Philadelphia area, we also have a presence in Washington DC, and Boston.
We are seeking support of a Quality Control / Analytical SME for an engagement with a CDMO in Denmark. This is a full-time contract role. Work will need to be completed onsite. Project is estimated at 6 months (possible extension).
Role Title: Quality Control / Analytical SME – CDMO

QUALIFICATIONS:

• BS or MS degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or related discipline.
• 5-8+ years of experience in GMP QC laboratory, with direct involvement in mammalian cell culture - upstream and/or downstream operations.
• Strong knowledge of analytical techniques (e.g., HPLC, GC, spectroscopy, compendial methods) and associated GMP documentation requirements.
• Proven experience reviewing QC documents, analytical data, and technical reports.
• Familiarity with deviation, OOS, and OOT investigation processes.
• Excellent attention to detail, organizational skills, and ability to manage multiple priorities in a client-driven environment.
• Strong communication skills and ability to interact effectively with both internal teams and external clients.
  Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
  Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols

ROLE SUMMARY:

The QC / Analytical SME is responsible for ensuring the accuracy, completeness, and compliance of all QC documentation, including test records, analytical reports, and data packages for a client-sponsored program. The QC/Analytical SME will provide subject matter expertise in analytical testing, data review, and GMP documentation practices. QC SME partners with QC analysts, QA, and client teams to ensure high-quality, on-time deliverables that meet regulatory, internal, and client-specific requirements.

KEY RESPONSIBILITIES:

• Review QC documentation, including analytical test records, raw data, and final reports, for completeness, accuracy, and compliance with GMP, regulatory guidelines, and client specifications.
• Verify calculations, data integrity, and adherence to approved analytical methods and SOPs.
• Act as QC subject matter expert for analytical testing and documentation review in a CDMO environment.
• Collaborate with QA, manufacturing, and client representatives to resolve data discrepancies or documentation issues.
• Support deviation investigations, OOS/OOT assessments, and root cause analysis related to QC testing.
• Ensure reviewed documents meet both regulatory requirements and client-specific quality standards.
• Participate in client audits and regulatory inspections, providing documentation and subject matter expertise.