Product Development Research Scientist II

About the role

Tris Pharma, Inc. is seeking two Product Development (PD) Research Scientists II to join the Platform and Product Feasibility (PPF) team at its Monmouth Junction, NJ facility. The PD Research Scientist II plans and executes pre‑formulation and formulation activities, contributing to the development of novel drug‑delivery platforms and differentiated products from conceptualization through pilot proof‑of‑concept (PoC). The role also includes pilot‑phase process development, cGMP pilot batch manufacturing, documentation, and collaboration with Analytical, Project Management, Clinical Development, and Quality Assurance teams.

Responsibilities

• Carry out work in accordance with company policies, SOPs, and applicable state, federal, and local laws.
• Plan and execute pre‑formulation and formulation activities with rigorous scientific standards to assess feasibility of novel drug‑delivery platforms, generate supporting data for intellectual property, and create invention disclosure forms.
• Plan, coordinate, and execute cGMP pilot batches, including protocols, master batch records, and reports, under senior staff guidance.
• Document all study details and results in laboratory notebooks and batch records compliant with Good Documentation Practices (GDPs) and cGMP; summarize data, discuss results, and draw conclusions in technical reports.
• Perform physical and chemical characterization in liaison with analytical teams.
• Ensure cleanliness and proper functioning of laboratory areas and maintain equipment and instruments.
• Collaborate with Analytical and Project Management to meet project timelines and study milestones; present and update project status, issues, and challenges to management.
• Assist Clinical Development with coordination of pilot pharmacokinetic (PK) studies, including protocol review, submission of pilot batches to CROs, and PK data review.
• Author regulatory submission documents for Pre‑INDs and INDs covering pre‑formulation and formulation development.
• Create and revise SOPs as needed.
• Work with Quality Assurance on investigations, CAPAs, and Change Controls to ensure timely closure.

Requirements

• Masters degree in Pharmaceutical Sciences, Pharmaceutics, Industrial Pharmacy, or a related scientific discipline + 3–5 years experience in product development or formulation laboratory in the pharmaceutical/biotechnology industry; OR Ph.D. in the same fields + 0–2 years experience.
• Hands‑on experience designing and conducting pharmaceutical formulation and process development studies with high scientific rigor, supporting multiple dosage forms (solid, liquid, extended‑release, etc.).
• Strong understanding of Physical Pharmacy and Pharmaceutics.
• Excellent technical writing skills, including preparation of SOPs, investigations, protocols, and reports.
• Working knowledge of FDA, OSHA, DEA, cGMP, and GLP regulations and guidances.

Compensation

Anticipated salary range: Masters degree + 3–5 years experience – $90,000 to $115,000 per year; Ph.D. degree + 0–2 years experience – $85,000 to $110,000 per year. Base salary is contingent on education, experience, industry standards, and internal equity.

Benefits

• Bonus eligibility
• Medical, dental, vision, and prescription drug insurance
• 401(k) plan with employer match
• Life insurance
• Paid company holidays
• Paid time off (PTO)
• Paid volunteer time
• Employee Resource Groups