Hybrid Quality Control/ Analytical SME bei Tunnell Consulting

Tunnell Consulting is an employee-owned, life sciences management consulting firm. We are known for solving complex problems in life science, and we support the mission and objectives of biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. Tunnell is headquartered in the Philadelphia area with offices 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

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.

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.