P&PF/Product Development Director

Description

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have more >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We 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 fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. But of equal importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success.

We have an opening in our Monmouth Junction, NJ facility for an experienced, Director, Platform and Product Feasibility to join our Product Development team.

The Director, Platform and Product Feasibility (PPF) leads the development team in building novel technology platforms and early-phase product portfolio to support a robust pipeline. She/he provides technical guidance within and outside R&D for due diligence, regulatory and quality matters and other cross-functional discussions, issue resolutions and activities.

RESPONSIBILITIES

• Carries out responsibilities in accordance with the organization's policies, Standard Operating Procedures (SOPs), and state, federal and local laws
• Builds early-phase product portfolio to establish robust and Intellectual Property (IP) protected pipeline for novel technology platform together with PPF Chief Scientist and senior R&D leadership; Conducts due diligence and feasibility analysis in collaboration with BD for products/assets being considered for acquisition or in-licensing
• Leads, directs and oversees PPF team in building novel technology platforms for molecular/chemical entities and drug delivery technology; Develops project strategies and approaches for novel technology platform to meet business goals and IP/FTO strategies. Performs competitive analysis
• Directs conceptualization of technology platforms and oversees early-phase feasibility/development activities, including characterization, pre-formulation, formulation evaluation and pilot scale up studies to ensure commercializability and good scientific understanding; Ensures proper documentation in notebooks/batch records is compliant with current Good Documentation Practices (cGDP) and cGMP; Reviews and approves protocols, master batch records and reports
• Creates invention disclosures; collaborates with internal and external counsel to perform patent landscape analysis, draft patent applications and responds to office actions
• Performs critical data analysis and modeling using statistical tools, including stability, In Vitro In Vitro Correlation (IVIVC) and PK modeling; Uses problem solving tools to troubleshoot
• Builds external academic and CRO/CDMO network to expand technical and development capabilities; Liaises, coordinates and manages early development activities with network
• Presents and updates product ideas, research findings, project status, and issues/challenges to senior leadership
• Reviews and finalizes regulatory submission documents for Pre-Investigational New Drugs and Investigational New Drugs (INDs) covering pre-formulation and formulation development
• Searches and reviews scientific literature to remain current with the developments in drug delivery technologies, pharmaceutical sciences, pharmaceutics, and pharmacokinetics; Enhances internal technical competence
• Creates and revises PD Standard Operating Procedures (SOPs), as needed
• Leads PD department matters and initiatives, including continuous improvement and streamlining of R&D processes/systems
• Provides technical guidance within and outside R&D for regulatory and quality matters; Authors and reviews scientific information packages for internal and external use
• Manages, coaches and mentors direct reports

Requirements

REQUIRED QUALIFICATION

• Masters degree in Pharmaceutical Science or related scientific field and minimum 20 years experience in pharmaceutical formulation and product development in positions of increasing strategic and leadership responsibility (minimum 10 of those years managing direct reports) OR PhD degree in Pharmaceutical Science or related scientific field and minimum 15 years experience in pharmaceutical formulation and product development in positions of increasing strategic and leadership responsibility (minimum 8 of those years managing direct reports).
• Proven success in leading early-phase feasibility and proof-of-concept evaluations for innovative concepts with high scientific standard
• Proven success in in identifying and implementing new delivery platforms and innovative dosage form designs, especially complex and difficult-to-formulate controlled release products.
• Proven ability in building and overseeing product portfolios to establish robust pipeline and developing project strategies and approaches
• Proven experience guiding early feasibility using pharmaceutics and PK/biopharmaceutic principles
• Proven experience in product technical viability evaluation
• In-depth, working 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 ability to build team culture that emphasizes on quality, performance, collaboration and continuous improvement

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.

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