Head of Analytical Services - Biologics GMP Leader

AL Solutions; Philadelphia (Philadelphia County); On-site; USD 140,000 - 190,000; Full time

Job summary

AL Solutions in Philadelphia is seeking a Manager/Senior Manager for Analytical Services to lead a growing team, drive method development, validation, transfer, and GMP testing, and own key analytical programs.

You will mentor Scientists and Associates, provide hands-on technical guidance, and partner with QA and cross-functional teams to ensure timely, compliant deliverables for biotherapeutic programs.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, or Pharmaceutical Sciences; MS/PhD preferred.
• 10–12+ years of analytical experience in biotech, pharma, or CDMO environments.
• Advanced expertise in HPLC/UPLC, chromatography, CE/CE-SDS/cIEF, GC or related platforms.
• GMP-regulated lab experience; release, characterization, in-process, and stability testing.

Responsibilities

• Lead, manage, and mentor a team of Scientists and Associates within Analytical Services.
• Provide day-to-day technical guidance and hands-on lab support to team members.
• Lead analytical method development, 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, deviations, 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 mitigate risks.
• Allocate resources and manage workload to meet milestones and client deliverables.
• Conduct 1:1s, performance reviews, development planning, and technical training for direct reports.

Skills

Leadership

Team management

Project management

Technical mentoring

Education

Bachelor’s degree in Chemistry/Biochemistry/Pharmaceutical Sciences

MS or PhD preferred

Tools

Empower

GMP testing instruments

Job description

AL Solutions in Philadelphia is seeking a Manager/Senior Manager for Analytical Services to lead a growing team, drive method development, validation, transfer, and GMP testing, and own key analytical programs.

You will mentor Scientists and Associates, provide hands-on technical guidance, and partner with QA and cross-functional teams to ensure timely, compliant deliverables for biotherapeutic programs.