Product Development Scientist II — Formulation & PoC

Tris Pharma Inc

South Brunswick (NJ)

On-site

USD 85,000 - 115,000

Full time

14 days+

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Benefits offered by this job

bonus eligible

medical

dental

vision

Rx insurance

401K with match

life insurance

paid Company Holidays

PTO

Paid Volunteer Time

Employee Resource Groups

Job summary

Tris Pharma, Inc. seeks a Product Development Research Scientist II to join the Platform and Product Feasibility team in Monmouth Junction, NJ.

The role plans and executes pre-formulation and formulation activities to support novel drug delivery platforms from concept to PoC, and to develop pilot cGMP batches with proper documentation. The candidate will collaborate with Analytical and Project Management to meet timelines, prepare technical reports, and contribute to IP creation and regulatory

Qualifications

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 REQUIRED
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.) REQUIRED
Good understanding of Physical Pharmacy and Pharmaceutics REQUIRED
Good technical writing skills, including SOPs, investigations, protocols, reports REQUIRED
Working knowledge of FDA, OSHA, Drug Enforcement Administration (DEA), cGMPs and GLPs regulations and guidances REQUIRED

Responsibilities

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