Manager / Sr Manager Analytical Services

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.

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.