Analytical Operations SME

Subject Matter Expert - Analytical Operations & Process Optimization (CDMO)

Location:

Europe (Multi-site travel required - up to 70%)

Industry:

Contract Development and Manufacturing Organization (CDMO) - Pharmaceuticals / Biotech

Position Overview

We are seeking an experienced and driven Subject Matter Expert (SME) in large-scale analytical testing to join a high-impact team supporting a leading CDMO client across multiple European sites. This role is ideal for a professional with deep expertise in operational efficiency, analytical process improvement, and troubleshooting complex laboratory operations, who thrives in a dynamic, multi-site environment.

As a trusted advisor to the client's operations, you will play a pivotal role in scaling up, standardizing, and optimizing analytical processes in line with global best practices. Your contributions will directly support commercial and late-stage development programs.

Key Responsibilities

• Act as a technical lead and subject matter expert for analytical laboratory operations across multiple CDMO sites in Europe.
• Identify and implement operational efficiencies, including automation opportunities, data workflows, and right-first-time improvements.
• Drive harmonization and standardization of processes and documentation across labs.
• Support analytical method optimization, troubleshooting, and tech transfer initiatives.
• Collaborate with Quality, Production, and R&D teams to ensure GMP compliance and regulatory readiness.
• Deliver training, workshops, and mentoring to site teams on best practices in analytical operations and continuous improvement (CI).
• Analyze KPIs and operational data to identify trends, root causes, and performance gaps.
• Champion the adoption of LEAN, 5S, and OPEX methodologies to increase lab productivity and reduce variability.

Ideal Candidate Profile

• Degree in Chemistry, Pharmaceutical Sciences, or related scientific discipline.
• 8+ years of experience in analytical laboratories within pharmaceutical or biotech environments, ideally in a CDMO setting.
• Proven track record of process improvement, troubleshooting, and analytical scale-up.
• In-depth knowledge of GMP, ICH guidelines, and analytical instrumentation (e.g., HPLC, GC, Empower).
• Experience implementing LEAN/OPEX/5S principles in laboratory settings.
• Strong communication and interpersonal skills, with ability to influence cross-functional teams and engage at all organizational levels.
• Willingness to travel extensively across Europe (up to 70%).

What We Offer

• Strategic and impactful role with high visibility
• Exposure to cutting-edge pharmaceutical and biotech projects
• Opportunity to work across diverse European operations
• Competitive compensation and travel package
• Collaborative, innovation-driven culture