Principal Scientist, Biological Characterization Analytical R&D

Job Description

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:

• Stay updated on the scientific industry and regulatory landscape actively publish and engage with the scientific community to influence the field.

• 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.

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Required Skills:

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

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 employees 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 at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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