Associate Principal Scientist – Biologics Potency

Job Description

Position Description:

Associate Principal Scientist – Biologics Potency

We are seeking a highly motivated and experienced Associate Principal Scientist to join our Biologics Potency team within the Cell Based Sciences, Analytical Research and Development organization of our Research & Development Division.

The primary role of the successful candidate will be to lead the design, method development, optimization and transfer of immune- and cell-based assays for drug substance and drug product release, stability, and characterization that reflect the mechanisms of Action (MoAs) for our Biologics pipeline. As part of this role, they will author and review CMC sections of regulatory submissions and associated source technical reports and risk assessment documents. The ideal candidate should bring expertise in a wide variety of immunological and cell methods and technology for assessment of biological potency with an emphasis on subject matter expertise related to potency assays for biologicals and new drug modalities.

The qualified candidate will be responsible for program potency strategy, developing, establishing pre-qualification and robustness, and transferring immunoassays and cell-based potency assays to assess the biological activity of various biologics modalities such as antibodies, multifunctional proteins, peptide therapeutics, antibody-drug-conjugates, and novel biologics. In our framework of scientific excellence, the associate principal scientist will be an active individual contributor and guide fellow scientists to the design, execution, and interpretation of potency assays, as well as to the ongoing innovation by proposing, evaluating, and implementing innovative approaches in the field of potency assays.

The successful candidate would have a deep understanding of underlying biological mechanisms and assay principles, with experience in key techniques, such as immunoassay platforms, stable cell line generation and/or cell-based assay development to assess the potency of drug candidates. Experience with multiple techniques and technologies, e.g. flow cytometry or lab automation, will be advantageous. The successful candidate should cultivate and foster scientific and technological innovation, leverage external networks to stay current on industry best practices and emerging technologies in potency assay development, champion new initiatives, and seek to enhance functional capability and operational excellence.

The candidate will need to communicate results effectively, write technical reports, advise fellow scientists, and participate in cross-functional teams. Experience of working in a GxP regulated laboratory environment for routine sample testing, documentation, and data verification will be a plus.  Experience of working with novel biological drug modalities will be a plus.

Position Qualifications:

Education Minimum Requirement:

• Ph.D. in immunology, cell biology, bioengineering, biological sciences, or related discipline with a minimum of 4 years of experience in the biopharmaceutical industry.

• OR a Master’s degree with a minimum of 8 years of experience in the biopharmaceutical industry.

• OR a Bachelor’s degree with a minimum of 12 years of experience in immunology, cell biology, bioengineering, biological sciences, or related discipline in the biopharmaceutical industry.

Required Experience and Skills:

• Experience with design and development of robust and reliable immunoassays and cell-based potency assays that reflect the MOA of antibody, ADC and/or other biological drug modalities.

• Hands on experience with development of immunoassays, cell-based assays and proficiency in a variety of biological and immunological techniques such as stable cell line generation, cytotoxicity assays, ELISAs, flow cytometry, Octet, proliferation, phosphorylation and reporter gene assays.

• Proficient in common bioassay software and data analysis packages e.g. SoftMax Pro, JMP, PLA software, or GraphPad Prism, and Microsoft Office Tools.

• Demonstrated ability to deliver complex objectives with ability to work effectively in a collaborative, fast-paced and dynamic cross-functional team environment.

• A strong team player with excellent oral and written communication skills; to independently design, execute and troubleshoot experiments; and analyze, interpret, and clearly communicate complex analytical data.

Preferred Experience and Skills:

• Experience with novel biomolecule drug modalities.

• Background in the development of new methods and sound scientific understanding of Quality by Design (QbD) and Design of Experiments (DOE) principles as well as data analysis and statistics