Analytical Product Leader

Within the Analytical R&D group, the Analytical Product Leader will be in charge of managing and implementing the global analytical strategy of her/his products portfolio (2-4 projects), in alignment with the GSK Vaccines R&D and TRD strategies, and in accordance with Quality by Design (QbD) principles.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Deliver and implement the consolidated global analytical strategy of her/his products portfolio (2-4 projects), in alignment with the GSK Vaccines R&D and TRD strategies, and in accordance with Quality by Design (QbD) principles.
• Influence the success of Analytical Technical Development by being one voice of ARD with TDT, RA and QC from early through late stage and life-cycle management.
• Accountable for the methods development according to the Analytical Target Profile (responsibility for SM Dev) and the GMP release and stability testing plan, through both the Analytical Development platforms and the GMP unit.
• Manage the product understanding (characterization) of clinical phase 1-2 and Phase 3, commercial products and LCM.
• Manage the analytical support to process understanding (antigen and product characterization needs) with other TRD functions using state of the art technologies for analytics and data interpretation.
• Manage the critical material and reagents strategy and ensure their availability in due time.
• Raise and manage any risk/issues on critical path to TDT and to ARD functions (budget, capacity, technical).

Why you?

Basic Qualifications:

• Ph.D. in biological, analytical, or pharmaceutical chemistry, or similar science/engineering field with 5+ years in analytical development.
• OR MS in biological, analytical, or pharmaceutical chemistry, or similar science/engineering field with 10+ years in analytical development.

Preferred Qualifications:

• Experience with product characterization of vaccines drug candidates and/or recombinant proteins, monoclonal antibodies, fusion proteins, conjugates.
• Strong influencing and communication skills.
• Experience leading/managing in a matrix team or having had direct reports.
• Experience in technology transfer in manufacturing.
• Ability to work with cross-functional teams and communicate effectively.
• Sound scientific methodology and thinking.