Senior Sterile & Ophthalmic Formulations Scientist

Nevakar Pharmaceuticals Inc; Bridgewater (MA); On-site; USD 110,000 - 170,000; Full time

Job summary

Nevakar Pharmaceuticals, Inc. is seeking a Formulations Scientist on-site in Bridgewater, NJ to support sterile injectable and ophthalmic drug product development.

The role involves pre-formulation, formulation development, process development, and optimization, with emphasis on small molecule candidates and regulatory submissions. The successful candidate will design experiments, analyze data, and communicate results while contributing to scalable manufacturing processes and collaboration with

Qualifications

• Master’s degree in Pharmaceutical Sciences, Chemical Engineering, or a related field is required; Ph.D. is preferred.
• Minimum of 2+ years of experience in early- or late-stage formulation development of small molecule drug products.
• Experience with sterile dosage form development, including parenteral and/or ophthalmic formulations.
• Experience with drug-device combination product development.
• Strong understanding of small molecule chemistry, degradation pathways, characterization methods, and stabilization techniques.
• Ability to design and conduct experiments, analyze data, troubleshoot technical challenges, and clearly communicate results.
• Experience with hospital injectable products, 505(b)(2) product development, and container closure systems preferred.
• Knowledge of extractables and leachables considerations and familiarity with FDA and EMA pharmaceutical development expectations is preferred.
• Experience managing or working with external CROs and CDMOs is preferred.
• Technical writing skills for pIND & NDA filings required.

Responsibilities

• Design, conduct, and interpret pre-formulation, formulation development, process development, and process optimization studies for sterile injectable and ophthalmic drug products.
• Develop and evaluate formulations for small molecule drug candidates, including solutions, lyophilized products, sterile injectable suspensions, and alternate drug delivery systems.
• Support screening activities to optimize solubility, stability, manufacturability, and product performance.
• Manufacture prototype dosage forms and support the development of robust, scalable manufacturing processes.
• Prepare, review, and contribute to product development reports, technical documents, and regulatory submissions, including Pre-IND, IND, NDA, and ANDA filings.
• Maintain accurate laboratory documentation in accordance with scientific, regulatory, and intellectual property requirements.
• Collaborate with cross-functional development teams and external partners to support project goals, milestones, technology transfer, and commercialization activities.
• Demonstrate scientific creativity, initiative, sound judgment, and a commitment to team and company objectives.

Skills

Formulations development

Sterile dosage forms

Ophthalmic formulations

Parenteral formulation

Data analysis

Independent experimentation

Education

Master’s degree in Pharmaceutical Sciences or related field

Ph.D. preferred

Job description

Nevakar Pharmaceuticals, Inc. is seeking a Formulations Scientist on-site in Bridgewater, NJ to support sterile injectable and ophthalmic drug product development.

The role involves pre-formulation, formulation development, process development, and optimization, with emphasis on small molecule candidates and regulatory submissions. The successful candidate will design experiments, analyze data, and communicate results while contributing to scalable manufacturing processes and collaboration with