Jobs at Nevakar Pharmaceuticals

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

• 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.

• 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 filings required, and interpersonal skills.
• Ability to work effectively in a collaborative, multidisciplinary team environment.