Job Description
The Small Molecule Analytical Research and Development (SMAR&D) group has an exciting opportunity for a Director role as GxP Strategic Lead based in Rahway, NJ. Join us and experience our culture firsthand - one of strong ethics & integrity, diversified experiences, exceptional science, and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
As GxP Strategic Lead, you will be part of a team that supports execution of analytical methodologies to characterize and release raw materials, package components, clinical drug substance, and clinical drug product for our small molecule portfolio. In this role, you will work with the GMP Analytical and Raw Materials teams on strategies associated with Operational Excellence. The role also involves strategic partnering with Development Quality, Process Research & Development, Pharmaceutical Operations, and other parts of the AR&D organization in aspects of quality control and compliance. Your main responsibilities will include:
Strategy and Operational Excellence:
- Driving operational deliverables including timely release of clinical materials by actively partnering with the GxP 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 GMP processes while maintaining high-level of compliance and 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 via presentations to key partner groups or serving as a subject matter expert during GxP 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.
- Planning critical business needs, which can include impact of the external business, regulatory, and compliance environment.
- Promoting our company's scientific excellence and regulatory influence through leadership in the scientific community.
Qualifications
Education Minimum Requirements:
- 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.
- Thorough working knowledge of GMPs, ICH, and relevant FDA guidelines.
- Possess strategic experience in operational control strategy development and execution.
- Demonstrated ability for taking initiative, creativity, and innovation in problem solving.
- 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:
- Ability to design, execute and/or direct the development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development.
- Project management skills.
- Established scientific or regulatory reputation supported by publications and/or external presentations.