George Higginson is currently partnered with a leading biologics CDMO that is expanding its Analytical Services team in Philadelphia, Pennsylvania, and is looking to appoint an experienced Laboratory Services Manager.
This is an excellent opportunity for a hands-on laboratory operations leader to take ownership of sample management, laboratory infrastructure, equipment maintenance, safety, and GMP compliance while directly managing and developing a team of laboratory technicians.
The successful candidate will play a critical role in ensuring laboratory operations run efficiently, remain inspection-ready, and consistently support scientific teams in delivering high-quality analytical services.
Key Responsibilities:
- Lead, mentor, and develop a team of laboratory technicians, overseeing daily operations, workload allocation, performance management, and professional development.
- Oversee all sample management activities, including receipt, storage, tracking, chain of custody, stability samples, and temperature-controlled shipping.
- Manage laboratory infrastructure, equipment maintenance, calibration, preventive maintenance programs, and vendor service agreements.
- Ensure laboratory operations remain fully compliant with cGMP requirements, internal quality standards, and applicable EHS regulations.
- Lead laboratory inspection readiness initiatives and support regulatory audits, including FDA and other relevant inspections.
- Develop, implement, and continuously improve laboratory SOPs, training programs, inventory systems, and operational processes.
- Oversee laboratory safety programs, incident investigations, corrective actions, and ongoing facility upkeep.
- Manage third-party laboratory relationships, equipment procurement, vendor contracts, and external service providers.
- Partner closely with Analytical Services, QA, QC, Manufacturing, and Supply Chain teams to ensure seamless laboratory operations.
- Drive continuous improvement initiatives to enhance operational efficiency, data integrity, regulatory compliance, and laboratory performance.
Requirements:
- Bachelor's degree in Life Sciences, Chemistry, Biochemistry, Biology, or a related scientific discipline.
- 8-10+ years of laboratory operations experience, including at least 3 years of direct people management experience.
- Essential: Experience managing laboratory operations within a GMP-regulated pharmaceutical, biotechnology, or CDMO environment.
- Demonstrated expertise across both sample management/logistics and laboratory facilities, safety, and instrument maintenance.
- Proven experience supporting and leading successful regulatory inspections, including FDA, EMA, or equivalent.
- Strong knowledge of GMP quality systems, SOP management, deviations, CAPAs, change controls, and data integrity requirements.
- Experience developing or improving laboratory management systems, including preventive maintenance, training, and inventory programs.
- Strong vendor management, equipment procurement, and service contract negotiation experience.
- Excellent leadership, communication, organizational, and problem-solving skills.
Why Apply?
This is an exciting opportunity to join a growing biologics CDMO and take full ownership of laboratory operations within a highly collaborative Analytical Services environment.
You’ll have the opportunity to develop a high-performing team, implement operational improvements, and play an integral role in maintaining the quality, compliance, and efficiency of a growing laboratory function.