Director of Biologics Potency - Analytical R&D

Job Description

The Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion of the Biologics portfolio from candidate selection through launch.  The successful candidate will be responsible for resourcing planning, risk assessment strategies, talent development, and partnering to build a culture of innovation and inclusion. 

The Director reports to the Executive Director, Cell Based Sciences and will be directly responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey.  The position is accountable for developing integrated potency strategy and required analytical methods, including supporting assay transfer to GxP laboratories.  He/she will be responsible for managing quality science and effective prioritization to bring analytical representation and expertise to project teams and support regulatory filings (e.g., INDs/IMPDs and BLAs). 

The Director selects, trains, and effectively works with colleagues to action development plans of personnel under her/his direction within the framework of Company policy.  The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit and promotion planning). Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific excellence, compliance mindset and collaboration with various partners and stakeholders in development.

The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.  Research and industry experience should demonstrate successful application and management of state-of-the-art analytical techniques to solve problems, sound scientific understanding of Critical Quality Attributes and Quality by Design principles, and advanced data analysis for drug development applications. 

Requirements:

• Ph.D. in biochemistry, analytical chemistry, molecular biology, cell biology, virology or related field with a minimum of 5 years of relevant experience; OR M.S. with a minimum of 8 years of experience; OR Bachelors with a minimum of 15 years of experience in the Pharmaceutical Industry.

• A strong aptitude for and previous experience in managing inclusive scientific teams and attracting, developing, and retaining diverse talent.

• Expertise in applying advanced concepts in cell biology and immunology to solve complex scientific and operational challenges related to designing and developing GxP assays, including ELISA and cell-based assays for Biologics development.

• Expertise in a variety of technologies, such as cell line engineering to build reporter gene assays, flow cytometry, natural killer (NK) cell assays for cytotoxicity, and/or effector function assays.

• Strong knowledge and statistical skills for interpretation of potency data in context of broader process and product development, control strategy, and specifications-setting. 

• Deep working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing regulatory submissions and responses and interacting with Health Authorities.

• Ability to effectively manage a portfolio of projects, multi-task in a highly dynamic environment, and influence cross-functional teams in a professional and positive manner.

• Excellent verbal and written communications skills and an ability to excel in a team-based environment.

• Strength in delivering results on firm deadlines in support of compound discovery, development and commercial filing.

Preferred Experience and Skills:

• Strong external scientific reputation including publications, regulatory guidance documents, presentations at scientific meetings, membership on (or leading) cross-company working groups or consortia.

• Proven ability to direct development of new, innovative approaches including your past work with new assay or robotic technology evaluation and shaping scientific strategy both at the platform and program level.

• Project management and/or scientific over-sight of work outsourced to Clinical Research Organizations (CROs).

#AR&D #EligibleforERP

NOTICE FOR INTERNAL APPLICANTS

In accordance with