Product Development Scientist II – Formulation & PoC Innovator

BioSpace; South Brunswick (NJ); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with match

Life insurance

Paid company holidays

Paid time off

Job summary

Tris Pharma, Inc. is seeking two PD Research Scientists II at our Monmouth Junction, NJ facility to join the Platform and Product Feasibility (PPF) team.

You will plan and execute pre-formulation and formulation activities, contributing to development of novel drug delivery platforms and IP from concept to PoC. The role includes planning cGMP pilot batches, documenting results, and collaborating with Analytical and Project Management to meet milestones; you will prepare regulatory submissions

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
• 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, DEA, cGMPs and GLPs regulations and guidances REQUIRED

Responsibilities

• Plans and executes pre-formulation and formulation activities to assess feasibility of novel drug delivery platforms and differentiated products from conceptualization to pilot proof of concept (PoC); generates data for IP and creates invention disclosures
• 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 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 status to management
• Collaborates with Clinical Development to coordinate pilot PK studies and submits data to CROs; reviews PK data for regulatory understanding
• Authors regulatory submission documents for Pre-INDs and INDs
• Creates and revises SOPs, and collaborates with QA on investigations, CAPAs and Change Controls

Skills

Pharmaceutical formulation

Pre-formulation

Process development

Technical writing

Education

Masters degree in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy or related scientific discipline

Ph.D. degree in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy or related scientific discipline

Job description

Tris Pharma, Inc. is seeking two PD Research Scientists II at our Monmouth Junction, NJ facility to join the Platform and Product Feasibility (PPF) team.

You will plan and execute pre-formulation and formulation activities, contributing to development of novel drug delivery platforms and IP from concept to PoC. The role includes planning cGMP pilot batches, documenting results, and collaborating with Analytical and Project Management to meet milestones; you will prepare regulatory submissions