Associate Principal Scientist – Bioassay, Cell Based Sciences, AR&D

Job Description

Large Molecule Analytical within our Companys Research Laboratories is seeking a highly motivated senior scientist with extensive experience developing potency assays for biologics to join the Biologics Potency team within Cell-Based Sciences in Rahway New Jersey. The successful candidate will apply scientific expertise and creativity to solve complex project challenges across the large molecule portfolio including therapeutic proteins monoclonal antibodies antibody-drug conjugates and/or complex modality-based products. The 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 enhance functional capability and operational excellence.

Key Responsibilities:

• Define potency strategy and develop and optimize immune binding assays and cell-based assays for biologics development.

• Conduct non-GMP qualification and robustness studies and perform non-GMP sample testing.

• Support potency method transfers and validation at GxP testing laboratories.

• Represent potency on cross-functional product development teams.

• Contribute to the authoring and review of regulatory submissions and technical reports.

• Provide scientific mentoring to junior scientists.

• Communicate effectively with stakeholders in partner organizations management and governance teams.

• Maintain accurate and detailed laboratory records.

Qualifications:

• Ph.D. in cell biology immunology biochemistry molecular biology or a related field with a minimum of 4 years of industry experience in the biopharmaceutical industry; M.S. in cell biology immunology or a related field with a minimum of 8 years of relevant industry experience; or B.S. in cell biology immunology or a related field with a minimum of 12 years of relevant industry experience.

• Expertise in cell biology and immunology with application to solving complex scientific and operational challenges related to designing and developing GxP potency assays to support a variety of large molecule modalities; experience in new modality-based therapy development is preferred.

• Hands-on experience developing immune binding assays and cell-based functional assays with proficiency in a variety of biological and immunological techniques such as stable cell line generation cytotoxicity assays ELISAs flow cytometry and reporter gene assays.

• Working knowledge of Quality by Design (QbD) and Design of Experiments (DOE) principles as well as strong statistical skills for data interpretation in the context of broader process and product development.

• Proficiency in common bioassay software and data analysis packages such as SoftMax Pro JMP PLA software GraphPad Prism and Microsoft Office tools.

• Experience mentoring peers and junior scientists.

• Working knowledge of regulatory guidance and quality standards with experience authoring and reviewing regulatory submissions and responses and interacting with health authorities.

• Track record of scientific engagement which may include scientific publications industry white paper contributions and presentations at scientific meetings.

• Ability to excel in a team-based environment by partnering and influencing in a professional and positive manner.

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

• Excellent verbal and written communication skills.

#AR&D

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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.

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