Hybrid MS&T SME bei Tunnell Consulting
Tunnell Consulting · Berwyn, Vereinigte Staaten Von Amerika · Hybrid
- Senior
- Optionales Büro in Berwyn
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.
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 an MS&T 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: MS&T SME
Position Summary:
The MS&T SME will play a critical role within a CDMO providing technical and strategic support for mammalian biologics manufacturing. This position is responsible for supporting both upstream and/or downstream operations, managing process investigations, deviation resolution, and ensuring execution of PPQ batches. The ideal candidate will bring deep process knowledge, hands-on experience within GMP manufacturing, and proven ability to collaborate with external clients and internal teams.
Key Responsibilities:
- Manufacturing Support: Provide hands-on support for GMP manufacturing (upstream and/or downstream), ensuring process execution aligns with technical expectations and regulatory requirements.
- PPQ Expertise: SME in PPQ planning and execution, including process readiness, sampling strategies, and data analysis.
- Investigations: Manage deviation investigations related to process performance, material variances, or equipment issues. Author and close investigations including CAPAs in a timely manner.
- Client Interaction: Technical POC during client meetings and project reviews; ensure alignment between client expectations and manufacturing outcomes.
- Process Monitoring: Analyze and trend process performance data to assess consistency, identify risks, and recommend improvements.
- Documentation: Prepare and review technical protocols, reports, batch records, and SOPs.
Qualifications:
- BS or MS degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or related discipline.
- 5+ years of experience in biologics manufacturing, with direct involvement in mammalian cell culture - upstream and/or downstream operations.
- Proven experience in a CDMO or multi-client manufacturing environment.
- Demonstrated expertise in PPQ execution and associated regulatory expectations.
- Strong knowledge of GMP regulations, quality systems, and deviation/investigation lifecycle.
- Exceptional written and verbal communication skills; experience presenting to clients and cross-functional stakeholders.
Preferred Qualifications:
- Trackwise experience is a plus.
- Experience with BLA or other regulatory submission preparedness.
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.
