Product Development Scientist II - Formulation & PoC

BioSpace; South Brunswick (NJ); On-site; USD 90,000 - 115,000; Full time

Job summary

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

You will plan and execute pre-formulation and formulation activities for novel drug delivery platforms, developing PoC concepts and supporting IP creation. You will also manage pilot cGMP batches, document results, and collaborate across Analytical, Clinical Development and QA to ensure timely milestones and regulatory readiness.

Qualifications

• Master's or PhD with relevant experience in product development or formulation lab
• Hands-on experience designing and conducting pharmaceutical formulation and process development studies
• Good understanding of physical pharmacy and pharmaceutics
• Strong technical writing skills including SOPs, investigations, protocols, and reports
• Working knowledge of FDA, OSHA, DEA, cGMPs and GLPs and related guidances

Responsibilities

• Plan and execute pre-formulation and formulation activities to assess feasibility of novel drug delivery platforms and generate supporting IP data
• Plan, coordinate and execute cGMP pilot batches with master batch records and reports under supervision
• Document study details in notebooks and batch records following GDPs and cGMP; summarize data and prepare technical reports
• Collaborate with analytical and project management teams to meet timelines and milestones
• Coordinate with Clinical Development on pilot PK studies and coordinate outsourcing to CROs as needed
• Prepare regulatory submission documents for Pre-IND and IND development
• Create and revise SOPs as required
• Collaborate with QA on investigations, CAPAs and change controls

Skills

Pharmaceutical formulation

Scientific writing

Regulatory knowledge

Laboratory skills

Education

Master's degree in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy

PhD in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy

Tools

cGMP equipment

Job description

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

You will plan and execute pre-formulation and formulation activities for novel drug delivery platforms, developing PoC concepts and supporting IP creation. You will also manage pilot cGMP batches, document results, and collaborate across Analytical, Clinical Development and QA to ensure timely milestones and regulatory readiness.