Executive Director, Biologics Analytical Research and Development

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Job description

Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover the next medical breakthrough.

Our team in Rahway, New Jersey, is seeking an exceptional leader who is passionate about leading a team of Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering to build an integrated culture of innovation across modalities and will partner with cross-functional development teams to enable pipeline decisions.

The Executive Director, Biologics Analytical Research and Development (B-AR&D) is responsible for providing strategic and technical leadership for analytical development of candidates from the discovery interface, through first product registration. They will be responsible for a portfolio of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic partnering with Biologics Analytical Research and Development method development GMP laboratories, complementary areas of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing is essential.

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, including strong background and experience in separations science, extensive experience with UPLC/HPLC analysis of biologics (e.g. SEC, RP, IEX), experience in microbiological techniques, ELISA, PCR, cell based analytics, background in analytical methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications. The incumbent will be responsible for the recruiting, appraisal and development of personnel under their supervision.

The Executive Director selects, trains, and effectively works with colleagues to action development plans of personnel under their direction within the framework of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and mentoring organizational leaders in talent Development. 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.

Education:

• BS Degree with 17+ years of relevant experience or MS with 10+ years of relevant experience or Ph.D. in analytical chemistry or related field with 8+ years of relevant experience in the pharmaceutical industry

Required Experience and Skills:

• Excellent verbal and written communication skills, demonstrated creativity, strong interpersonal and collaborative skills

• Demonstrated ability in leading cross-functional groups with proven talent development skillsets.

• Ability to work in a team environment with cross-functional interactions is essential

• Strength in delivering results on firm deadlines in support of compound from development through Commercialization

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

• Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and safety.

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