PD Research Scientist II: Formulation & Pilot PK

Tris Pharma, Inc.; New Jersey; On-site; USD 90,000 - 115,000; Full time

Benefits offered by this job

Bonus eligible

Medical

Dental

Vision

Rx insurance

401K with match

Life insurance

Paid Holidays

PTO

Paid Volunteer Time

Employee Resource Groups

Job summary

Tris Pharma, Inc. in Monmouth Junction, NJ is seeking a Product Development (PD) Research Scientist II to join the Platform and Product Feasibility (PPF) team.

You will plan and execute pre-formulation and formulation activities to develop novel drug delivery platforms from concept to PoC, creating IP and supporting early regulatory submissions. Responsibilities include piloting cGMP batches, coordinating with Analytical and Project Management to meet milestones, and preparing technical reports.

Qualifications

• Master's degree with 3–5 years in product development or formulation lab.
• PhD with 0–2 years experience in product development or formulation lab REQUIRED.
• Experience designing and conducting formulation and process development studies.
• Strong understanding of Physical Pharmacy and Pharmaceutics.
• Excellent technical writing for SOPs, investigations, and reports.
• Knowledge of FDA/OSHA/DEA regulations, cGMPs and GLPs.

Responsibilities

• Plan and execute pre-formulation and formulation activities for PoC development.
• Coordinate and execute cGMP pilot batches with protocols and reports.
• Document study details in notebooks and batch records per GDPs and cGMP.
• Collaborate with analytical and project management to meet milestones.
• Assist QA on investigations, CAPAs and change controls.
• Prepare regulatory submission documents for Pre-INDs and INDs.

Skills

Pharmaceutical formulation

Process development

Technical writing

Regulatory knowledge

cGMP/GLP knowledge

Regulatory compliance

Education

Master's degree in Pharmaceutical Sciences

PhD in Pharmaceutical Sciences

Job description

Tris Pharma, Inc. in Monmouth Junction, NJ is seeking a Product Development (PD) Research Scientist II to join the Platform and Product Feasibility (PPF) team.

You will plan and execute pre-formulation and formulation activities to develop novel drug delivery platforms from concept to PoC, creating IP and supporting early regulatory submissions. Responsibilities include piloting cGMP batches, coordinating with Analytical and Project Management to meet milestones, and preparing technical reports.