Technical Project Lead

Abzena•Bristol, PA

About The Position

The Technical Project Lead serves as the primary technical integrator for Analytical Services, coordinating cross-functional analytical activities and aligning project scope, timelines, technical strategy, resources, risks, and client expectations. The role works closely with Analytical Development, Quality Control, Manufacturing, Quality Assurance, Regulatory, Project Management, and other technical functions to support successful client programs. The position provides technical oversight of analytical activities from project initiation through completion, including method development, qualification, validation, transfer, characterization, release testing, in-process testing, stability testing, and other analytical support as applicable to program scope. The role combines scientific knowledge, project leadership, and client-facing capabilities to ensure project deliverables meet scientific and quality standards and are completed in accordance with GMP requirements, company procedures, approved protocols, client requirements, and regulatory expectations. The Technical Project Lead also supports project scoping, proposals, change orders, schedules, resource planning, regulatory content, and continuous improvement in analytical project execution and communication.

Requirements

Bachelor’s, Master’s, or Ph.D. degree in Analytical Chemistry, Biochemistry, Biological Sciences, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline.
Significant experience in biopharmaceutical analytical development, analytical sciences, or quality control.
Demonstrated experience leading complex analytical programs or coordinating analytical activities across multiple technical functions.
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, potentially including 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.
Ability to lead technical teams in a matrix environment without relying on direct reporting authority.
Strong project management and organizational skills, including 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.
Ability to identify risks early, establish mitigation strategies, drive decisions, and escalate appropriately.
Strong interpersonal and influencing skills, with the ability to collaborate across Analytical Services, Manufacturing, Quality, Project Management, and client organizations.
Strong written communication skills and 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.

Nice To Haves

Advanced degree in a relevant scientific discipline.
Experience in a CDMO, biotechnology, or pharmaceutical environment.
Experience in a client-facing or cross-functional project environment.

Responsibilities

Serve as the technical project lead for Analytical Services programs, coordinating and overseeing analytical activities from project initiation through completion.
Lead cross-functional analytical project teams and coordinate analytical disciplines to define and achieve program objectives, deliverables, and timelines.
Act as a primary technical interface among Analytical Services, Project Management, clients, and internal cross-functional teams.
Develop and maintain analytical strategy and execution plans with analytical subject matter experts and functional leadership.
Coordinate method development, qualification, validation, transfer, characterization, release, stability, and investigational testing, as applicable.
Define and communicate project scope, assumptions, deliverables, dependencies, and technical requirements.
Monitor project execution against timelines and identify resource constraints, technical challenges, dependencies, and delivery risks.
Lead analytical project risk management, including mitigation planning and timely escalation of significant technical or operational issues.
Coordinate with analytical subject matter experts to evaluate technical data, method performance, investigations, deviations, change controls, and other execution-impacting issues.
Facilitate analytical project, technical, and client meetings; document decisions, actions, owners, and due dates and track them through closure.
Communicate project status, milestones, risks, dependencies, resource needs, and critical issues to leadership, Project Management, and stakeholders.
Support development and review of analytical project scopes, proposals, change orders, timelines, and resource requirements with Business Development, Project Management, and functional leadership.
Partner with Analytical Services management on capacity and resource planning to support realistic schedules and delivery commitments.
Ensure analytical deliverables, including protocols, reports, specifications, methods, and technical assessments, meet 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 comply with applicable GMP requirements, Abzena procedures, approved protocols, client requirements, and regulatory expectations.
Build 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.