Manager / Sr Manager Analytical Services

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

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.

Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.

We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

The Manager/Sr. Manager, Analytical Services provides technical and operational leadership for an assigned analytical team. This role leads method development, qualification, and routine testing activities within its area of focus, ensures team delivery against project timelines and quality standards, and holds full project ownership for assigned programs. The Manager/Sr. Manager mentors team members, drives GMP compliance, and maintains cross-functional alignment to support broader department goals.

Responsibilities

Team Leadership & Supervision

• 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 across team members to meet project demands.
• Foster a culture of collaboration, accountability, and continuous improvement.

Project Management & Accountability

• Develop and continuously update project timelines, ensuring alignment with project goals and deliverables; maintain a live list of all projects led by you or a team member.
• Demonstrate full ownership and accountability for every assigned task, ensuring timely, high-quality delivery at all stages.
• Keep project stakeholders informed with accurate, up-to-date information, and help guide teams toward informed decisions.
• Maintain regular touch points with cross-functional teams (e.g., Process Development) and coordinate closely with QA during qualification activities.
• Take full responsibility for ensuring data is compiled, reviewed, and available to stakeholders at any stage of a project.
• Actively support QA with Laboratory Investigations (LIs) arising on assigned projects.
• Review all documents generated by the team before submission to QA for final review.

Method Development, Qualification & GMP Compliance

• Lead method development activities within the team's area of focus, including complex method design and execution.
• Own method qualification strategies, documentation, and timelines for the assigned platform(s).
• Lead OOS investigations and CAPAs, and serve as the GMP testing liaison for the team.
• Ensure all laboratory practices comply with quality, safety, and regulatory standards.

Training, Stability & Cross-Functional Collaboration

• Drive training execution for assigned methods/platforms across the team.
• Support process development testing and stability testing (GMP and non‑GMP).
• Serve as the technical representative for the assigned area of focus in cross-functional project meetings.
• Collaborate with SMEs and other Managers/Sr. Managers to identify and mitigate technical risks.

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 sufficient cross-platform understanding to assess technical risk, resource work, and challenge scientific conclusions.
• HPLC/UPLC: Able to oversee development and lifecycle performance of chromatographic methods, including column/mobile‑phase/gradient selection, system suitability, integration strategy, troubleshooting, robustness, qualification/validation, transfer, and GMP readiness.
• GMP testing: Accountable for team readiness and compliant execution of release, in‑process, characterization, and other GMP testing; ensures trained analysts, qualified instruments, approved methods/specifications, contemporaneous documentation, peer review, deviation management, and on‑time delivery.
• Stability testing: Oversees GMP and non‑GMP stability testing, including schedule/capacity planning, timepoint execution within protocol windows, sample and method readiness, data review, trend awareness, OOS/OOT escalation, and coordination with Stability, QA, QC, and project teams.
• Method lifecycle and investigations: Leads qualification/validation strategy, transfer readiness, method changes, OOS/OOT/Laboratory Investigations, root‑cause assessment, CAPA, and continuous improvement using sound scientific and regulatory judgment.
• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field; Master's or PhD preferred.
• 10-12 years of relevant analytical experience, with a focus aligned to the assigned team (chromatography/HPLC, CE/GC, or compendial/raw material testing).
• Demonstrated experience in a GMP environment.
• Prior supervisory, team lead, or senior scientist mentoring experience.

FLSA

Exempt

Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.