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.