Principal Scientist (Director), Analytical R&D Full-time

Principal Scientist

Our ability to excel relies on the innovation, integrity, expertise and teamwork of our scientists. We value rigorous scientific exploration, cross-functional collaboration, creative-thinking and dedication to building strong and operationally excellent teams. As part of our industry-leading drug development programs, you will have the opportunity to collaborate with highly talented and dedicated colleagues, working urgently to develop lifesaving medicines and vaccines and deliver the next medical breakthroughs.

The Analytical Research & Development department of our Company Research Laboratories Division is seeking an experienced and highly-motivated Principal Scientist with extensive cell-based characterization assay development expertise. The successful candidate will have experience with the design, execution and optimization of a broad range of characterization assays and be responsible for development of analytical control strategies for structure function assessment of biologic modalities (e.g. mAb, antibody-drug conjugates, fusion proteins, immunomodulatory molecules, immune-cell engagers, and complex peptide/protein modalities). The applicant will have the opportunity to engage in cross-functional teams to drive effective problem solving and innovation across the Biologics pipeline in a fast-paced, multidisciplinary environment.

This is a full-time position reporting to the Director in the Analytical Research and Development department and is located at our corporate headquarters and research facilities in Rahway, New Jersey.

Responsibilities include, but are not limited to:

• Work closely with the group Director to define and execute analytical control strategy for biological characterization at all stages of clinical development, as well as for post-approval support.
• Lead experimental design, development and implementation of robust MoA-reflective in vitro cell-based functional assays (i.e. binding, proliferation, cell-signaling, cytotoxicity, cytokine production), using primary cells, luminescence- and fluorescence-based reporter assays, flow cytometry, and cell imaging.
• Serve as scientific supervisor providing technical and scientific expertise to a team of scientists, enabling delivery of pipeline and strategic initiatives. Guide and mentor junior scientists in experimental design, data interpretation and documentation. Inspire, encourage and support employee development, partner with the director to build independent ownership and evolution of specializations within the team.
• In active collaboration with management, contribute to continuous improvement of team productivity via enhancing effective organizational skills, accurate resource planning and prioritization, utilization of best practices and standardization of processes, and evaluation of innovative scientific and technological tools.
• Drive scientific objectives associated with the development of new/improved products or technology and utilize effective networking to solve complex scientific and technical problems. Lead the development of a toolkit for characterization of novel biologics modalities for deep structure-function understanding.
• Author and review experiment lab notebooks, independently analyze results and effectively communicate results and scientific data to cross-functional teams. Provide data interpretation for structure-function assessments, connecting PTM relationships with deep mechanistic characterization of functional biological activity to inform critical product and process quality attributes.
• Author analytical reports and analytical sections of regulatory filings. Primary author of external publications, presentations, regulatory documents and/or primary inventor of patents.
• Represent the team on internal scientific forums and leading external scientific conferences and actively engage with the external scientific community, industry and regulatory landscape.

Minimum Education Requirements:

• Ph.D. with 8+ years, MS with 10+ years, or BS with 14+ years of experience in Immunology, Cell Biology, Molecular Biology, Biochemistry, Pharmacology, Biotechnology or a related field.

Required Experience, Skills, and Competencies:

• Strong technical expertise in the design of biological characterization assays for therapeutic proteins, monoclonal antibodies and antibody-drug conjugates. In-depth understanding and hands-on experience with the development of cell-based functional assays, flow cytometry, molecular biology and mammalian cell-line engineering.
• Demonstrated expertise in comprehensive characterization of molecular function and impact of structural changes on biological activity, CQA assessment, expertise in interpretation of data in context of broader process and product development, critical reagent characterization and overall analytical control strategy.
• Excellent interpersonal, verbal and written communication skills, with the ability to convey complex scientific concepts clearly. Demonstrated initiative, creativity, and innovation in problem solving.
• Demonstrated ability to develop talent, supervise, coach and mentor others.
• Ability to adapt to and prioritize complex objectives under tight timelines in a dynamic cross-functional environment.
• Demonstrated expertise with authoring of regulatory submissions and interactions with health authority agencies.
• Established scientific reputation and external influence, supported by publications, patent authoring, external presentations at scientific meetings, membership in (or leading) cross-company working groups or consortia.

Preferred Experience & Skills:

• Previous experience in project management or leading cross-functional teams is a plus
• In vitro immunogenicity assessment, with focus on risk assessment for biologics and novel biologic modalities is a plus.
• Proficiency in statistical analysis and equivalency assessment is a plus
• Previous working experience with pharmacokinetics (PK) assessment and bioanalytical assay development is a plus.
• Proficiency in confocal microscopy and high-content imaging is a plus.

Required Skills: Analytical Method Development, Assay Development, Bioanalytical Analysis, Chromatographic Techniques, Dosage Forms, Liquid Chromatography (LC), Manufacturing, Mentoring Staff, Method Validation, Stability Testing

Preferred Skills: Characterization Techniques, Flow Cytometry, Mammalian Cell, Molecular Biology, Scientific Publications