Product Development Research Scientist II

Tris Pharma•Monmouth Junction, NJ

1d•Onsite

About The Position

Tris Pharma, Inc. is a biopharmaceutical company focused on developing and commercializing innovative medicines. They have an opening for a Product Development (PD) Research Scientist II to join their Platform and Product Feasibility (PPF) team at their Monmouth Junction, NJ facility. This role involves planning and executing pre-formulation and formulation activities to develop novel drug delivery platforms and differentiated products from conceptualization to pilot proof of concept (PoC), creating commercially viable intellectual property (IP). The incumbent will also plan and execute pilot-phase process development and manufacture cGMP pilot batches, including documentation. Collaboration with Analytical and Project Management is key to meeting project timelines and milestones. The role requires preparing technical reports, feasibility reports, invention disclosures, and early-phase regulatory submission documents.

Requirements

Masters degree in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy or related scientific discipline AND 3-5 years experience in a product development or formulation laboratory in the pharmaceutical or biotechnology industry OR Ph.D. degree in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy or related scientific discipline AND 0-2 years experience in a product development or formulation laboratory in the pharmaceutical or biotechnology industry
Hands on experience in designing and conducting pharmaceutical formulation and process development studies with high scientific rigor, supporting multiple dosage forms (i.e., solid, liquid and/or extended release, etc.)
Good understanding of Physical Pharmacy and Pharmaceutics
Good technical writing skills, including SOPs, investigations, protocols, reports
Working knowledge of Food and Drug Administration (FDA), Occupational Safety and Health Administration (OSHA), Drug Enforcement Administration (DEA), cGMPs and GLPs regulations and guidances

Responsibilities

Carries out responsibilities in accordance with the organization’s policies, Standard Operating Procedures (SOPs), and state, federal and local laws
Plans and executes pre-formulation and formulation activities with good scientific standards to assess feasibility of novel drug delivery platforms and differentiated products from conceptualization to pilot proof of concept (PoC); generates supporting data for Intellectual Property (IP) and creates relevant invention disclosure forms
Plans, coordinates and executes cGMP pilot batches, including protocols, master batch records and reports, under the guidance of senior staff
Documents all study details and results in laboratory notebooks and batch records compliant with current Good Documentation Practices (GDPs) and cGMP
Summarizes data, discusses results and makes conclusions in technical reports
Performs physical and chemical characterization in liaison with analytical teams
Ensures cleanliness and functioning of lab areas and proper maintenance of equipment and instruments
Collaborates with Analytical and Project Management to ensure project timelines and study milestones are met; Presents and updates project status and issues/challenges to management
Collaborates with, and assists, Clinical Development with the coordination of pilot PK studies, including protocol review, submission of pilot batches to Contract Research Organizations (CROs), Pharmacokinetics (PK) data review and understanding
Authors regulatory submission documents for Pre-Investigational New Drugs (Pre-INDs) and Investigational New Drug Applications (INDs), covering pre-formulation and formulation development
Creates and revises SOPs, as needed
Collaborates with Quality Assurance (QA) on investigations, Corrective Action Preventive Action (CAPAs) and Change Controls to ensure timely closure