Associate Director/Director AR&D

1 week ago

Monmouth Junction, New Jersey, United States Tris Pharma Full time
Job Title: Associate Director/Director AR&D

Tris Pharma, Inc. is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Job Summary

The Associate Director/Director, Analytical Research and Development (R&D) leads Analytical Research and Development (AR&D) teams in analytical method development, physical characterization, formulation support, interim validation, pilot release testing and stability testing activities for all R&D and Technical Services (TS) projects. The incumbent ensures thorough characterization of formulations and drug delivery technologies under development and builds in-house analytical capabilities, when needed.

Key Responsibilities
  • Leads and directs AR&D teams for all analytical method development, physical characterization, formulation support, interim validation, pilot testing release and stability testing activities for all R&D and TS projects.
  • Ensures approaches, strategies, timelines, quality and goals compliant with SOPs/cGMPs/policies are met across AR&D.
  • Reviews and approves all regulatory submissions and other relevant scientific packages for internal and external use.
  • Ensures all testing details and results are documented in laboratory notebooks and appropriate record sheets compliant with Good Documentation Practices (GDPs) and SOPs.
  • Manages, coaches and mentors direct reports.
Requirements

Masters degree in Analytical Chemistry and minimum 10 years experience in the pharmaceutical, biotechnology or related scientific field with relevant research background and characterization of complex chemistry in positions of increasing strategy, operational and leadership responsibilities.

Proven success in leading analytical R&D, including method development and physical characterization with high scientific standard. Current, in depth experience with, and understanding of, physical characterization, thermal, spectroscopic, mass spectrum and chromatographic techniques and concepts. Deep understanding of analytical sciences and up-to-date on novel analytical instrumentation and techniques.

Ability to manage/oversee method development needs, including ability to develop unique methods for complex technologies. In depth knowledge of Food and Drug Administration (FDA), cGMPs, Drug Enforcement Administration (DEA), Occupational Safety and Health Administration (OSHA), SOPs and regulatory rules, regulations and guidelines.

Proven track records of analytical R&D experience in Chemistry Manufacturing and Controls (CMC) environment in the pharmaceutical field. Ability to influence without direct authority. Proficiency with Microsoft Office. Excellent verbal and written communication and skills. Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members.

Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

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