Analytical Services Manager - GMP Leadership Method Dev

Abzena; 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 to provide technical and operational leadership for an analytical team.

You will own method development, qualification, and routine testing activities, ensure GMP compliance, and maintain cross‑functional alignment to support program goals. You will mentor scientists, drive project timelines, and collaborate with QA during investigations while ensuring timely, high‑quality data delivery for stakeholders throughout

Qualifications

• Platform leadership: Advanced-to-expert working knowledge of the assigned analytical area (HPLC/UPLC, CE/CE-SDS/cIEF, GC, or compendial/physicochemical testing) with cross‑platform understanding to assess risk and guide team.
• HPLC/UPLC: Oversee development and lifecycle performance of chromatographic methods including validation, transfer, and GMP readiness.
• GMP testing: Ensure readiness and compliant execution of release, in‑process, characterization, and other GMP testing with proper documentation.
• Stability testing: Oversee GMP and non‑GMP stability testing, including planning, timepoint execution, data review, and cross‑functional coordination.
• Method lifecycle and investigations: Lead qualification/validation strategy, transfer readiness, method changes, OOS/OOT investigations, CAPA, and continuous improvement.
• Bachelor's degree + 10–12 years in analytical science with GMP experience and supervision experience.

Responsibilities

• Lead, mentor, and manage a team of Scientists and Associates within the assigned team.
• Provide day‑to‑day technical guidance and hands‑on laboratory support to team members.
• Conduct regular 1:1s, performance reviews, and development planning for direct reports.
• Allocate resources and manage workload distribution to meet project demands.
• Foster a culture of collaboration, accountability, and continuous improvement.
• Develop and continuously update project timelines and maintain ownership of project deliverables.
• Keep stakeholders informed with accurate information and guide teams toward informed decisions.
• Coordinate with QA during qualification activities and ensure data is ready for stakeholders at any stage.
• Lead GMP testing readiness and act as the testing liaison for the team.
• Ensure laboratory practices comply with quality, safety, and regulatory standards.
• Drive training for methods/platforms and support stability testing in GMP and non-GMP contexts.
• Serve as the technical representative in cross‑functional project meetings and mitigate technical risks.

Skills

Platform leadership

HPLC/UPLC

GMP testing

Stability testing

Method lifecycle & investigations

Cross-functional collaboration

Education

Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field

Master's or PhD preferred

Job description

Abzena is seeking a Manager/Sr. Manager, Analytical Services in the United States to provide technical and operational leadership for an analytical team.

You will own method development, qualification, and routine testing activities, ensure GMP compliance, and maintain cross‑functional alignment to support program goals. You will mentor scientists, drive project timelines, and collaborate with QA during investigations while ensuring timely, high‑quality data delivery for stakeholders throughout