Formulations Scientist/Sr. Scientist

Description

Company Description

Nevakar Pharmaceuticals, Inc. is a privately held specialty pharmaceutical company headquartered in Bridgewater, New Jersey. The Company develops enhanced sterile injectable products designed to address unmet clinical and commercial needs by improving existing FDA-approved molecules through innovative formulation, functional packaging, novel drug delivery approaches, and thoughtful regulatory and clinical strategies. Nevakar’s work is focused on creating patient-centered products that improve quality of life and healthcare outcomes while providing value to the healthcare system. Its development programs include IP-protected dosage forms, such as ready-to-use infusion bags and prefilled syringes, and are primarily advanced through the FDA’s 505(b)(2) regulatory pathway. As Nevakar enters its next chapter, the Company remains committed to scientific excellence, innovation, collaboration, and delivering accessible products that support better outcomes for patients and providers.

Position Summary

Nevakar Pharmaceuticals is seeking a Formulations Scientist onsite in Bridgewater, NJ to support the development of sterile injectable and ophthalmic drug products. The successful candidate will contribute to pre-formulation, formulation development, process development, and process optimization activities for small molecule drug candidates. This role requires strong scientific judgment, hands-on laboratory experience, and the ability to design experiments, analyze data, and communicate results in support of product development and regulatory submissions. Position title will be commensurate with experience. The formulation Scientist will be responsible for understanding small molecule chemistry, degradation pathways, characterization and stabilization techniques. The selected candidate will be supporting screening formulations for optimizing solubility and stability of drug candidates for ophthalmic and injectable drug products. Develop formulations for preclinical studies. Work with regulatory team in preparing PreIND meeting request and support IND and NDA submissions. Design and conduct pre-formulation, formulation development, process development and process optimization of parenteral and ophthalmic formulations and related alternate drug delivery systems such as solutions, lyophilized products, sterile injectable suspensions etc. Design and develop robust, scalable formulations, manufacture prototype dosage forms, and conduct drug product process development and process optimization activities in-house. Conduct literature search for the assigned projects. Demonstrate scientific creativity, initiative and contribution to the team and company goals. The individual will also be responsible for designing and executing different laboratory experiments, making observations, performing data analysis and reporting results.

Role and 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.
• •Conduct literature searches, evaluate scientific and technical information, and apply findings to assigned projects.
• •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.

Requirements

• •Master’s degree in Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline is required; Ph.D. is preferred.
• •Minimum of 2+ years of experience in early - or late-stage formulation development of small molecule drug products is required .
• •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.
• •Demonstrated ability to independently 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, including vials, syringes, and infusion bags, is 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.
• •Strong organizational, written and verbal communication, technical writing skills for pIND & NDA filles required , and interpersonal skills.
• •Ability to work effectively in a collaborative, multidisciplinary team environment.