Director, Analytical R&D

Job Description

The Director reports to the Executive Director of SMAR&D and will lead a team of approximately 10-15 analytical scientists in Rahway that works closely within multidisciplinary DSCS teams.  This role has a wide responsibility for analytical method development and testing for chemical and biocatalytic synthetic processes, and / or a variety of formulations (e.g., oral, parenteral, and specialty dosage).  The director should be well engaged with regulatory and industry trends to guide future activities for Analytical R&D and DSCS. The candidate will have experience in an innovative analytical/regulatory/GMP environment.

The Director will effectively partner with the SMAR&D leadership team in order to identify and advance key departmental technical, strategic and cultural initiatives. The Director will identify, recruit, onboard and develop employees to their full potential. The candidate will establish a viable succession plan for key positions within SMAR&D (scientific and management pathways), including their own role.  The position is responsible for disclosures prepared within the group to be used as the basis for external publications and filings.  The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management, as necessary.

Maintaining an effective network internally, and across the external academic and regulatory community, is expected, as is as advancing a culture of scientific excellence, GMP and compliance mindset, and collaboration with various partners and stakeholders in development.

Essential Knowledge, Duties & Responsibilities include:

• Analytical methodologies

• Project management skills

• Review and approval of data

• Representation of the laboratory for internal and external audits

• Team and staff development

• Thorough working knowledge of GMPs, ICH, and relevant Health Authority regulatory guidelines

Education: 

• BS or MS in chemistry or related science with 10 years of industrial experience with pharmaceutical drug substance and/or product development.

• Ph.D. in chemistry or related science with 7 years of industrial experience with pharmaceutical drug substance and/or product development.

Required Skills:

• Demonstrated ability in leading teams.

• Track record of effective talent development

• Excellent scientific communication skills, demonstrated creativity, effective interpersonal and collaborative skills

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

• Strength in delivering results on firm deadlines in support of drug development and commercial filing

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