Technical Project Lead

Responsibilities

Serve as the technical project lead for Analytical Services programs, providing overall coordination and technical oversight of analytical activities from project initiation through completion.

Lead cross-functional analytical project teams and coordinate activities across analytical disciplines to ensure program objectives, deliverables, and timelines are clearly defined and achieved.

Serve as a primary technical interface between Analytical Services, Project Management, clients, and internal cross-functional teams.

Develop and maintain the overall analytical strategy and execution plan in collaboration with analytical subject matter experts and functional leadership.

Coordinate analytical activities including method development, qualification, validation, transfer, characterization, release, stability, and investigational testing, as applicable.

Ensure analytical project scope, assumptions, deliverables, dependencies, and technical requirements are clearly defined and communicated.

Monitor project execution against agreed timelines and proactively identify resource constraints, technical challenges, dependencies, and risks that could affect delivery.

Lead analytical project risk management, including identification of risks, development of mitigation strategies, and timely escalation of significant technical or operational issues.

Coordinate with analytical SMEs to evaluate technical data, method performance, investigations, deviations, change controls, and other issues that may impact program execution.

Facilitate analytical project meetings, technical discussions, and client meetings and ensure decisions, actions, owners, and due dates are appropriately documented and followed through to closure.

Provide clear and timely communication of project status, milestones, risks, dependencies, resource needs, and critical issues to Analytical Services leadership, Project Management, and other stakeholders.

Support development and review of analytical project scopes, proposals, change orders, timelines, and resource requirements in partnership with Business Development, Project Management, and functional leadership.

Partner with Analytical Services management on capacity and resource planning to support realistic project schedules and delivery commitments.

Ensure analytical deliverables, including protocols, reports, specifications, methods, technical assessments, and other project documentation, are completed to the appropriate scientific and quality standards.

Support preparation and technical review of analytical content for regulatory submissions and responses to client or health authority questions, as applicable.

Ensure project activities are performed in accordance with applicable GMP requirements, Abzena procedures, approved protocols, client requirements, and regulatory expectations.

Build strong collaborative relationships with clients and internal stakeholders and represent Analytical Services professionally in technical and project discussions.

Drive continuous improvement in analytical project execution, communication, planning, standardization, and tracking practices.

Qualifications

Education and Experience

Bachelor’s, Master’s, or Ph.D. degree in Analytical Chemistry, Biochemistry, Biological Sciences, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline.

Advanced degree preferred.

Significant experience in biopharmaceutical analytical development, analytical sciences, or quality control, preferably within a CDMO, biotechnology, or pharmaceutical environment.

Demonstrated experience leading complex analytical programs or coordinating analytical activities across multiple technical functions.

Experience working in a client-facing or cross-functional project environment is strongly preferred.

Technical Knowledge

Strong understanding of the analytical lifecycle, including method development, qualification, validation, transfer, characterization, release testing, and stability testing.

Working knowledge of analytical technologies used for biologics, which may include HPLC/UPLC, SEC, CE-SDS, icIEF/cIEF, LC-MS, UV/Vis, SoloVPE, potency assays, and other physicochemical and biochemical characterization techniques.

Understanding of analytical control strategies, critical quality attributes, specifications, reference standards, and stability programs.

Knowledge of GMP requirements and applicable regulatory expectations for analytical development and testing.

Experience reviewing technical protocols, reports, methods, specifications, investigations, and other controlled documentation.

Leadership and Core Competencies

Demonstrated ability to lead technical teams in a matrix environment without relying on direct reporting authority.

Strong project management and organizational skills with the ability to manage multiple programs, priorities, and deadlines.

Ability to translate complex scientific information into clear project decisions, risks, and actions.

Strong client-facing communication and presentation skills.

Demonstrated ability to identify risks early, establish mitigation strategies, drive decisions, and escalate appropriately.

Strong interpersonal and influencing skills with the ability to collaborate effectively across Analytical Services, Manufacturing, Quality, Project Management, and client organizations.

Strong written communication skills with the ability to prepare and review technical and GMP documentation.

Highly organized, accountable, and execution-focused with a strong commitment to quality and on-time delivery.