Principal Scientist, Biological Characterization Analytical R&D Full-time

Principal Scientist

The Analytical Research & Development department of our Company Research Laboratories Division is seeking applicants for a Principal Scientist position available at its Rahway, New Jersey research facility. We are looking for a collaborative, self-motivated scientific leader with expertise in biological characterization and structure function assessment of biologic modalities (e.g. mAb, antibody-drug conjugates, fusion proteins, immunomodulatory molecules, immune-cell engagers, and complex peptide/protein modalities). We collaborate closely with colleagues in Discovery, Pre-clinical, Early Development, Analytical, Formulation, and Commercial Manufacturing, to drive effective problem solving and innovation across the Biologics pipeline in a fast-paced, multidisciplinary environment. We value rigorous scientific exploration, cross-functional collaboration, creative-thinking and dedication to building strong and operationally excellent teams. Our ability to excel depends on the integrity, expertise, innovation and teamwork of our scientists. We strive to create an environment of mutual respect, diversity, encouragement and collaboration. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing your career.

Responsibilities include, but are not limited to:

• Work closely with the group Director to shape and execute strategy for biological characterization in all stages of clinical development, as well as for commercialization and in line commercial projects.
• Lead development and implementation of robust non-GMP characterization methods, using quality by design principles and with focus on comprehensive life-cycle management.
• Mentor and supervise junior colleagues; coach, and develop talent within the group, contribute to employee career development; build independent ownership and evolution of specializations within the team. Inspire, encourage and support scientific excellence.
• Foster strategic thinking to anticipate and support key partner needs. Utilize effective networking to solve complex scientific and technical problems.
• In active collaboration with management, contribute to continuous improvement in 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.
• Partner with management and project teams to help drive pipeline progression and strategic initiatives. Contribute to assessment of capability gap(s) and expand toolbox for characterization of new biologics modalities for structure-function understanding.
• Champion compliance and safety while promoting a culture of diversity, equity, and inclusion.
• Stay updated on the scientific, industry and regulatory landscape, actively publish and engage with the scientific community to influence the field.

Minimum Education Requirements:

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

Required Experience, Skills, and Competencies:

• Demonstrated ability to develop talent, supervise, coach and mentor others.
• Strong leadership skills and record of effective cross-functional collaboration, demonstrating initiative, creativity, and innovation in problem solving.
• Strong fundamental knowledge and subject matter expertise in cell biology and immunology.
• Expertise in design and development of biological characterization assays for therapeutic proteins, monoclonal antibodies, antibody-drug conjugates, and/or cell and gene therapy products.
• Expertise in comprehensive mechanistic structure function understanding and impact on biological activity.
• Strong expertise in interpretation of characterization data in context of broader process and product development, critical reagents characterization and overall analytical control strategy.
• Ability to adapt to and prioritize complex objectives under tight timelines in a dynamic cross-functional environment.
• Established strong scientific reputation for scientific excellence supported by publications, patent authoring, external presentations at scientific meetings, membership in (or leading) cross-company working groups or consortia.

Preferred Experience & Skills:

• Expertise in authoring regulatory guidance and quality standards, authoring and reviewing of regulatory submissions and responses (IND and BLA) and interacting with Health Authorities.
• In-vitro immunogenicity assessment, with focus on risk assessment for biologics and novel biologic modalities.
• Molecular Biology and cell line engineering, gene engineering, CRISPR.
• In-vitro characterization assays for pharmacokinetics (PK) assessment.
• Flow cytometry, confocal microscopy and high-content imaging.

Required Skills: Accountability, Analytical Method Development, Assay Development, Bioanalytical Analysis, Biotechnology, Chromatographic Techniques, Clinical Judgment, Communication, Cross-Functional Teamwork, Dosage Forms, Ethical Compliance, Flow Cytometry, Gene Therapy, Genetic Engineering, Immunoassays, Immunochemistry, Immunogenicity Assays, Immunology, Liquid Chromatography (LC), Matrix Management, Mentoring Staff, Method Validation, Microbiology, Molecular Biology, and more.

Preferred Skills:

The salary range for this role is $153,800.00 – $242,200.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available.