Principal Scientist - Large molecule critical reagents and reference standards

Job Description

Large Molecule Analytical Validation group within Analytical Research & Development, our company's Research Labs is seeking a motivated Principal Scientist with technical expertise in developing large molecule critical reagent strategies. The Principal Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems at the interface of analytical, regulatory and quality disciplines to enable robust commercial testing. More specifically, the ideal candidate will be a recognized expert developing reference standard and critical reagents based on mechanistic understanding of large molecule analytical methods. The successful candidate is expected to provide scientific expertise, and creativity to solve complex situations across the portfolio. They will be accountable to inspire and cultivate scientific rigor through implementation of innovative technologies and approaches to enable efficient critical reagent management in the program’s life cycle.

The ideal candidate will provide technical and scientific leadership to a group of 3-5 individuals, to support the robust large molecule pipeline. Responsibilities include representing the group on product development teams, defining and implementing large molecule critical reagent strategy, oversight of reagent qualifications/ testing, documentation, and scientific mentoring. The candidate will be expected to effectively communicate with management, governance teams, and stakeholders across the organization.

Education Requirements:

• Ph.D. in biological science, biochemistry, molecular biology, cell biology, virology with a minimum of 8 years of relevant biopharmaceutical industry experience OR M.S. with a minimum of 10 years of relevant experience

Required Skills and Experience:

• In-depth knowledge and understanding of analytical development, technical knowledge of potency assays reflective of mechanism-of-action, and immunoassays used in the development of biologics and vaccine products.

• Strong leadership skills, team spirit, and a passion for mentoring with effective organizational and multi-tasking ability.

• Demonstrated ability to interpret complex experimental designs and detailed data analysis concepts related to analytical method validations and reagent qualification/ re-evaluations.

• Experience with monitoring reagent/ assay performance and control for drifts in key quality attributes between and within reference standards, and analytical bridging studies.

• Deep working knowledge of regulatory guidance and quality standards, with experience devising reference standard strategy for large molecules (Vaccines and Biologics including therapeutic proteins, monoclonal antibodies, Antibody-drug conjugates). Candidates should have experience with authoring and reviewing regulatory submissions, and prior Health Authority engagements (e.g. Biologics license application submission).

• Demonstrated scientific track record of delivering impactful solutions to complex problems, and evidence of …