Associate Director/Director AR&D

Associate Director/Director, Analytical Research and Development Monmouth Junction, NJ • Analytical Development, R&D Tris Pharma, Inc. (www.trispharma.com) 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 science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other, and we believe in respectful, open and honest communications to help support individual and team success. 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. Job Title commensurate with experience. 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. 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. She/he also reviews and approves all scientific, technical and regulatory packages per International Council for Harmonization (ICH)/Food and Drug Administration (FDA) guidance and provides technical guidance within and outside R&D for regulatory and quality matters. The Associate Director/Director, AR&D serves as Deputy to the Executive Director, Analytical Development and provides technical guidance within and outside R&D for due diligence, regulatory and quality matters and other cross-functional discussions, issue resolutions and activities. ESSENTIAL FUNCTIONS Primary duties/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 to ensure method robustness and facilitate full product understanding; Ensures thorough characterization of formulations and drug delivery technologies under development; Ensures sound research into literature and critical data and statistical analysis are performed Reviews and approves all regulatory submissions and other relevant scientific packages for internal and external use; Leads design and execution of all development studies and ensures proper evaluation/trending of stability data for New Drug Application (NDA)/Abbreviated New Drug Application (ANDA) submissions Ensures all testing details and results are documented in laboratory notebooks and appropriate record sheets compliant with Good Documentation Practices (GDPs) and SOPs; Ensures accuracy of all data analysis and calculations associated with test analyses Ensures AR&D resources are properly managed to meet workload demands and all AR&D instruments are properly cleaned, calibrated and maintained in compliance with current Good Laboratory Practices (cGLPs) and cGMP Reviews and approves all AR&D SOPs Searches and reviews scientific literature and regulatory guidances to remain current with developments in analytical chemistry, physical characterization and pharmaceutical testing as well as latest regulatory requirements on specifications, methods, and nitrosamines; Continuously builds in-house analytical capabilities and enhances internal technical competence Prepares and presents written and oral reports on research findings, project status, literature reviews, and technical issues; Provides technical guidance within and outside R&D for regulatory and quality matters; Provides formal and informal training to AR&D department on technical subjects, administrative procedures and regulatory requirements Leads AR&D department matters and initiatives, including continuous improvement and streamlining of processes/systems; Justifies and implements appropriate instrumentation, computer programs and procedures Functions as Analytical Development Deputy in Executive Director’s absence; Builds and leads AR&D matters and initiatives, including continuous improvement and streamlining of AR&D processes/systems in productivity, efficiency and scientific quality standards Manages, coaches and mentors direct reports Requirements Requirements KNOWLEDGE/SKILLS/ABILITIES REQUIRED Minimum education and years of relevant work experience 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. Special knowledge or skills needed and/or licenses or certificates required 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 Fluent in English (verbal and written) Special knowledge or skills needed and/or licenses or certificates preferred PhD degree Experience working with biologics Experience managing direct and indirect reports Travel requirements 0% Physical requirements Laboratory based position.