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Tris Pharma - Monmouth Junction, NJ

posted 4 days ago

Full-time - Senior
Monmouth Junction, NJ
Chemical Manufacturing

About the position

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. Our AR&D lab is located in our Monmouth Junction, NJ headquarters has an immediate need for an experienced Associate Director/Director, Analytical Research & Development. 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. The incumbent ensures timeline, quality and compliance with applicable Standard Operating Procedures (SOPs)/current Good Manufacturing Practices (cGMPs)/policies are met and develops project strategies, approaches, timelines and goals for analytical milestones and deliverables as per project priorities.

Responsibilities

  • Carries out responsibilities in accordance with the organization's policies, Standard Operating Procedures (SOPs), and state, federal and local laws.
  • 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.
  • Represents AR&D in cross-functional discussions, issue resolutions and decisions.
  • Leads designs of method development and physical characterization studies for raw materials, in process materials and finished products.
  • 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.
  • Ensures AR&D resources are properly managed to meet workload demands.
  • Reviews and approves all AR&D SOPs.
  • Searches and reviews scientific literature and regulatory guidances to remain current with developments in analytical chemistry.
  • Prepares and presents written and oral reports on research findings, project status, literature reviews, and technical issues.
  • Leads AR&D department matters and initiatives, including continuous improvement and streamlining of processes/systems.
  • Functions as Analytical Development Deputy in Executive Director's absence.
  • 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.
  • Proven success in leading analytical R&D, including method development and physical characterization.
  • Current, in depth experience with, and understanding of, physical characterization, thermal, spectroscopic, mass spectrum and chromatographic techniques.
  • 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 FDA, cGMPs, DEA, OSHA, SOPs and regulatory rules, regulations and guidelines.
  • Proven track records of analytical R&D experience in Chemistry Manufacturing and Controls (CMC) environment.
  • Ability to influence without direct authority.
  • Proficiency with Microsoft Office.
  • Excellent verbal and written communication skills.
  • Ability to work independently and collaboratively in a fast paced, matrixed, team environment.
  • Analytical thinking with excellent problem-solving skills.
  • Excellent planning, organization and time management skills.
  • Fluent in English (verbal and written).

Nice-to-haves

  • PhD degree.
  • Experience working with biologics.
  • Experience managing direct and indirect reports.
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