Senior Manager, Analytical Services

George Higginson is currently partnered with a leading biologics CDMO that is expanding its Analytical Services team in Philadelphia, PA.

As part of this growth, they are looking to hire a Manager / Senior Manager, Analytical Services . This is an excellent opportunity to take a key technical and people-leadership role within a growing organization supporting the development and manufacture of innovative biotherapeutics.

This position will provide technical and operational leadership for an analytical team, overseeing method development, qualification, validation, transfer, and routine GMP testing while taking full ownership of assigned analytical programs.

You will lead and mentor a team of Scientists and Associates while serving as a technical subject-matter expert across analytical development, GMP testing, investigations, and method lifecycle activities.

Responsibilities:

• Lead, manage, and mentor a team of Scientists and Associates within Analytical Services
• Provide day-to-day technical guidance and hands-on laboratory support to team members
• Lead analytical method development, optimization, qualification, validation, and transfer activities
• Take full ownership of analytical projects, including timelines, resources, data delivery, and technical execution
• Oversee GMP and non-GMP testing supporting release, characterization, process development, and stability programs
• Lead OOS/OOT investigations, Laboratory Investigations, root-cause assessments, and CAPAs
• Review analytical data, protocols, reports, and technical documentation prior to QA approval
• Provide technical oversight of Empower/CDS, including data review, integration, audit trails, and ALCOA+ compliance
• Ensure analysts, instruments, methods, specifications, and documentation are ready for compliant GMP execution
• Oversee stability testing activities, including capacity planning, timepoint execution, data review, and trend assessment
• Partner closely with QA during method qualification and investigation activities
• Work cross-functionally with Process Development, QC, Stability, and project teams to identify and mitigate technical risks
• Allocate resources and manage team workload to ensure project milestones and client deliverables are achieved
• Conduct 1:1s, performance reviews, development planning, and technical training for direct reports

Requirements:

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline; MS or PhD preferred
• 10–12+ years of relevant analytical experience within biotechnology, pharmaceutical, or CDMO environments
• Advanced technical expertise in HPLC/UPLC, chromatography, CE/CE-SDS/cIEF, GC, or related analytical platforms
• Strong experience with analytical method development, qualification/validation, troubleshooting, and technical transfer
• Demonstrated experience working within a GMP-regulated laboratory environment
• Strong understanding of release, characterization, in-process, and stability testing
• Experience leading OOS/OOT investigations, deviations, Laboratory Investigations, root-cause assessments, and CAPAs
• Advanced knowledge of Empower or equivalent chromatography data systems, including data integrity and ALCOA+ principles
• Experience authoring and reviewing analytical protocols, reports, SOPs, and controlled documentation
• Previous supervisory, team-leadership, or senior-level mentoring experience
• Strong project-management skills with the ability to manage multiple analytical programs, resources, and timelines

Preferred Experience:

• Direct people-management experience within Analytical Development, Analytical Services, or QC
• CDMO or client-facing analytical development experience
• Method lifecycle management from development through GMP implementation and transfer
• Experience supporting GMP and non-GMP stability programs
• Cross-functional collaboration with QA, QC, Process Development, Manufacturing, and Stability teams
• Experience managing analytical teams supporting multiple concurrent development programs

Why This Role?

This is an opportunity to take a key leadership position within a growing Analytical Services function at a leading biologics CDMO, combining scientific leadership, people management, and hands-on technical expertise. You will take ownership of analytical programs from method development through GMP execution, lead and develop a team of Scientists and Associates, and collaborate closely with Development, Quality, and project teams supporting innovative biotherapeutic programs.

If you’re interested in learning more, feel free to apply or message George Higginson directly for a confidential discussion.