Scientist, Formulation R&D

RXinsider LTD.; Piscataway Township (NJ); On-site; USD 117,000 - 120,000; Full time

Job summary

RXinsider LTD. in Piscataway, NJ, seeks a Scientist, Formulation R&D to develop and optimize solid dosage form formulations (tablets, capsules, and modified release). The role covers pre-formulation, dissolution profiling, analytical method support, and regulatory submission support.

Requires a Master's degree in Pharmacy, Chemistry, Pharmaceutics, or related field and at least 12 months of relevant experience. Salary is $117k–$120k per year; hours are 40 per week, 8:30am–5:30pm.

Qualifications

• Master's degree in Pharmacy, Chemistry, Pharmaceutics, or related field.
• 12 months of experience in formulation development or related role.
• Experience with pre-formulation studies and dissolution profiling.

Responsibilities

• Develop and optimize formulations for oral solid dosage forms (tablets, capsules, and modified release products).
• Conduct pre-formulation studies and excipient compatibility assessments.
• Support analytical method development and validation for assay, dissolution, and stability-indicating methods.
• Design and execute stability studies per ICH guidelines to establish shelf life.
• Troubleshoot formulation and analytical issues during development and scale-up.
• Collaborate with manufacturing and quality teams for pilot-scale and commercial-scale technology transfer.
• Prepare technical reports, development documents, and regulatory submission support (ANDA/CTD).
• Ensure adherence to cGMP, GLP, and regulatory requirements throughout development.

Skills

Formulation development

Analytical support

Regulatory documentation

Education

Master's degree in Pharmacy or Chemistry or Pharmaceutics

Job description

Job Description

Scientist, Formulation R&D:

• Develop and optimize formulations for oral solid dosage forms (tablets, capsules, and modified release products).
• Conducting pre-formulation studies, excipient compatibility assessments, and dissolution profiling.
• Supporting analytical method development and validation for assay, dissolution, and stability- indicating methods.
• Design and execute stability studies as per ICH guidelines to establish product shelf life.
• Perform troubleshooting of formulation and analytical issues during development and scale-up.
• Collaborate with manufacturing and quality teams for pilot-scale and commercial-scale technology transfer.
• Prepare technical reports, development documents, and regulatory submission support (ANDA/CTD).
• Ensure strict adherence to cGMP, GLP, and regulatory requirements throughout the development process.

Qualifications

Requirements

Must have at least a Master's degree in Pharmacy or Chemistry or Pharmaceutics, or related field . Must have 12 months of experience in the position or in a related position.

Salary: $117K - $120K per annum.

Hours: 40 hrs/wk 8:30am - 5:30pm

Location: Piscataway, NJ