George Higginson is currently partnered with a leading biologics CDMO that is expanding its Analytical Services team in Philadelphia, PA.
As part of this growth, they are looking to hire a Technical Project Lead, Analytical Services. This is an excellent opportunity to take a key scientific and project-leadership role within a growing organization supporting the development and manufacture of innovative biotherapeutics.
This position will serve as the primary technical lead for analytical programs, coordinating activities across Analytical Development, QC, QA, Manufacturing, Regulatory and Project Management to ensure successful delivery of complex client projects.
You will take ownership of analytical project execution, technical strategy, timelines, resources and risks while serving as a key technical point of contact for internal stakeholders and external clients.
Responsibilities:
- Lead and coordinate analytical programs from project initiation through successful completion.
- Develop and oversee analytical project strategies, technical plans, timelines, resources and deliverables.
- Coordinate analytical method development, qualification, validation, transfer, characterization, release and stability testing activities.
- Serve as a primary technical interface between Analytical Services, Project Management, clients and cross-functional teams.
- Lead technical project meetings, communicate progress and ensure project milestones are achieved.
- Identify and mitigate technical risks, resource constraints and potential project delays.
- Work closely with Analytical Development, QC, QA, Manufacturing and Regulatory teams to resolve technical challenges.
- Provide scientific oversight of analytical data, method performance, investigations, deviations and change controls.
- Support analytical project scoping, proposals, change orders and resource planning.
- Review analytical protocols, technical reports, specifications and project documentation to ensure scientific accuracy and GMP compliance.
- Drive continuous improvement in analytical project execution, communication and operational efficiency.
Requirements:
- Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences or a related scientific discipline; MS or PhD preferred.
- Significant experience within Analytical Development, Analytical Sciences or QC in a pharmaceutical, biotechnology or CDMO environment.
- Strong understanding of the analytical method lifecycle, including development, qualification, validation, transfer, characterization and GMP testing.
- Technical knowledge of biologics analytical platforms such as HPLC/UPLC, SEC, CE-SDS, cIEF/icIEF, LC-MS, UV/Vis or potency assays.
- Demonstrated experience leading complex analytical projects or coordinating activities across multiple technical functions.
- Strong understanding of GMP requirements, analytical control strategies, stability programmes and regulatory expectations.
- Experience reviewing analytical methods, protocols, technical reports, investigations and controlled documentation.
- Excellent project management skills, including managing timelines, technical deliverables, resources and competing priorities.
- Strong communication and stakeholder-management skills, with the ability to translate complex scientific information into clear project decisions.
Preferred Experience:
- Previous experience within a biologics CDMO or client-facing analytical development environment.
- Technical leadership of analytical programmes supporting multiple stages of biopharmaceutical development.
- Experience coordinating cross-functional teams without direct line-management responsibility.
- Experience supporting analytical method transfers, GMP implementation and regulatory submissions.
- Familiarity with ADCs, monoclonal antibodies or other complex biologic modalities.
- Experience supporting multiple concurrent client programmes, including technical risk management and resource planning.
Why This Role?
This is an opportunity to take a key technical leadership position within a growing Analytical Services function at a leading biologics CDMO.
You will play an integral role in driving analytical strategy, coordinating complex scientific programmes and ensuring successful delivery of client projects, working closely with scientific, manufacturing, quality and project leadership teams.
The position offers the opportunity to combine deep analytical expertise with project leadership, cross-functional collaboration and direct client interaction, supporting innovative biotherapeutic programmes from early development through GMP manufacturing.