Director, Small Molecule AR&D Strategic Operations Lead

Job Description

The Small Molecule Analytical Research and Development (SMAR&D) group has an exciting opportunity for a director role as Strategic Operations Lead based in Rahway, NJ. As the Strategic Operations Lead within the SMAR&D GxP Operations group, you will drive the strategy and logistics for the team responsible for analytical release of raw materials, package components, medical device components, clinical drug substance, and clinical drug product for our small molecule portfolio.

In this individual contributor role, you will help define the business and operational strategies enabling analytical release and ensure operational excellence across the GxP analytical team. The role also involves strategic partnering with Development Quality, Process Research & Development, Pharmaceutical Operations, and other parts of the AR&D organization to deliver on the small molecule portfolio. Your main responsibilities will include: 

Strategy and Operational Excellence:

• Driving operational deliverables including timely release of clinical materials by actively partnering with the Analytical teams and other functional areas.

• Serving as the analytical point of contact for key partner groups, maintaining open and active communication.

• Defining and implementing operational control strategies to ensure efficient and compliant processes while maintaining scientific rigor.

• Proactively identifying and escalating operational risks.

• Partnering with director-level management to develop and execute operational and enterprise strategies.

Leadership:

• Representing the team and/or department in strategic and operational discussions with key partner groups.

• Serving as a subject matter expert during audits and inspections.

• Fostering strong collaborations with internal stakeholders and external partners by actively engaging in two-way communication to build trusting relationships.

• Serving as a facilitator and mentor to empower others to succeed.

Impact and Influence:

• Anticipating and solving operational problems that may have broad impact to the business.

• Promoting our Company's scientific excellence and regulatory influence through leadership in the scientific community.

Qualifications

Education Minimum Requirements

Applicants must hold one of: ​

• PhD Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 7 years of pharmaceutical industry experience​.

• Master’s Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 10 years of pharmaceutical industry experience. ​

• Bachelor’s Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 12 years of pharmaceutical industry experience.   ​

Required Experience and Skills

A strong team player with excellent written and oral communication skills, as well as strong leadership and interpersonal skills are essential to this role. Additional skills:

• Experience in operational control strategy and execution.

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

• Demonstrated track record of taking initiative, creative problem solving, and innovation.

• Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.

• Demonstrated technical or operational leadership with significant and measurable project impact.

• Demonstrated ability to develop talent through good mentoring skills.

Preferred Experience and Skills ​

While not required, experience in one or more of the following areas is preferred: ​

• Project management skills

Current Employees apply HERE

Current Contingent Workers apply