Technical Project Lead

Abzena Inc.•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 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. This position combines scientific knowledge, project leadership, and client-facing capabilities. It provides oversight of analytical activities such as method development, qualification, validation, transfer, characterization, release testing, in-process testing, stability testing, and other analytical support, as applicable to program scope. The role also supports analytical strategy, execution planning, project risk management, resource planning, technical documentation, and regulatory content, while ensuring work meets applicable GMP, company, client, and regulatory requirements.

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, preferably in a CDMO, biotechnology, or pharmaceutical environment.
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, 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.
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 and 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 preferred.
Experience in a client-facing or cross-functional project environment is strongly preferred.

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 activities across analytical disciplines to achieve defined objectives, deliverables, and timelines.
Act as a primary technical interface between 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 execution against timelines and identify resource constraints, technical challenges, dependencies, and risks that may affect delivery.
Lead analytical project risk management, including identifying risks, developing mitigation strategies, and escalating significant issues.
Coordinate with analytical subject matter experts to evaluate technical data, method performance, investigations, deviations, change controls, and other program-impacting issues.
Facilitate project, technical, and client meetings; document decisions, actions, owners, and due dates and follow through to closure.
Communicate project status, milestones, risks, dependencies, resource needs, and critical issues to leadership and stakeholders.
Support development and review of 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.
Ensure analytical deliverables and project documentation 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 practices.