Senior Analytical Services Lead (GMP)

Lever, Inc.; Bristol Township (Bucks County); On-site; USD 140,000 - 190,000; Full time

Job summary

Abzena is seeking a Manager/Sr. Manager, Analytical Services in the United States. This role provides technical and operational leadership for an analytical team, owning method development, qualification, and routine testing activities while ensuring GMP compliance and timely project delivery.

You will mentor scientists, coordinate with QA during qualifications, and maintain cross-functional alignment to support broader department goals.

Qualifications

• Platform leadership in analytical area (HPLC/UPLC, CE/CE-SDS/cIEF, GC, or related testing).
• GMP testing readiness and compliance.
• Oversee stability testing in GMP/non-GMP.
• Lead qualification/validation strategy and investigations.
• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field; Master's or PhD preferred.
• 10-12 years of relevant analytical experience.
• Demonstrated experience in a GMP environment.
• Prior supervisory, team lead, or senior scientist mentoring experience.

Responsibilities

• Lead, mentor, and manage an analytical team.
• Provide day-to-day technical guidance and hands-on laboratory support.
• Conduct regular 1:1s, performance reviews, and development planning for direct reports.
• Allocate resources and manage workload across team members.
• Foster a culture of collaboration, accountability, and continuous improvement.
• Develop and update project timelines; own assigned programs.
• Ensure data is compiled and available to stakeholders.
• Support QA with Laboratory Investigations (LIs).
• Review documents before submission to QA for final review.
• Lead method development activities and qualification strategies.
• Own qualification strategies and timelines for assigned platforms.
• Lead OOS investigations and CAPAs; GMP testing liaison.
• Ensure all practices comply with quality, safety, regulatory standards.

Skills

Team Leadership

GMP Compliance

HPLC/UPLC

CE/CE-SDS/cIEF

Method Development

OOS Investigations

CAPA

Cross-functional Collaboration

Education

Bachelor's degree in Chemistry

Master's or PhD preferred

Tools

HPLC/UPLC

CE/CE-SDS/cIEF

GC

Job description

Abzena is seeking a Manager/Sr. Manager, Analytical Services in the United States. This role provides technical and operational leadership for an analytical team, owning method development, qualification, and routine testing activities while ensuring GMP compliance and timely project delivery.

You will mentor scientists, coordinate with QA during qualifications, and maintain cross-functional alignment to support broader department goals.