Director, Small Molecule Analytical Research and Development

Job Description

We are seeking a strategic and technical leader with expertise in developing analytical methodologies and innovative medicines. The primary objective of the Small Molecule Analytical Research and Development (SMAR&D) team is to conduct research and development activities in collaboration with various partners to facilitate process and formulation development.

In this role, the SMAR&D Director will provide guidance, lead initiatives, and build teams responsible for developing characterization methods to evaluate and release clinical drug substances and products and their stability tests for our research pipeline.

This research opportunity supports the Development Sciences and Clinical Supplies (DSCS) goals, which focus on creating robust chemical and biochemical processes and pharmaceutical formulations for non-sterile and sterile products. The position also involves strategic collaboration with Chemistry, Manufacturing, and Controls (CMC) and Regulatory teams regarding control strategies and regulatory filings, alongside Quality and partners in the commercialization and manufacturing divisions.

This challenging position requires a clear vision for team development, demonstrated leadership skills, critical thinking abilities, effective technical and communication skills, and a strong understanding of the drug development and regulatory landscape to influence it positively.

Nature and Scope of Position:

The Director reports to the Executive Director of SMAR&D and will lead a team of approximately 10-15 scientists in Rahway, who collaborate closely within multidisciplinary teams. This role encompasses a broad range of responsibilities, including oversight of the development of analytical methods and testing for chemical and biochemical processes, as well as parenteral, oral, and specialty dosage formulations. The Director should be well-informed about regulatory and industry trends to effectively guide future activities for Analytical R&D. The candidate must have experience working in an innovative analytical, regulatory, and GMP environment.

The Director will collaborate with SMAR&D leadership and extended leadership teams to identify and advance key departmental strategic and cultural initiatives. They will also be responsible for identifying, recruiting, onboarding, and developing employees to realize their full potential. Additionally, the candidate will contribute to establishing a viable succession plan for key positions within the functional area, including both scientific and management pathways, as well as for their own role. This position is responsible for ensuring that disclosures prepared by the group serve as the basis for external publications and filings. Furthermore, the Director will oversee proactive resource planning, risk assessment strategies, and necessary budget management.

Maintaining an effective network both internally and with the external academic and regulatory community is expected. The Director will also advance a culture of scientific excellence, GMP compliance, 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

• SOP development

• Quality System experience

• Team and staff development

• Thorough working knowledge of GMPs, ICH, and relevant FDA guidelines

Qualifications:

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:

• Demonstrated ability in leading teams with proven talent development skillsets.

• 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 substance and product development for clinical and commercial filings

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