Job Title: Drug Product Research Scientist
Department: Drug Product R&D
Location: Onsite, Cranbury NJ
Job Type: Full Time
Position Reports to: VP of Drug Product Development
Job Summary:
We are seeking a highly motivated and skilled Research Scientist to join our Drug Product R&D Department at Porton J-STAR. In this role, this position is responsible for leading formulation development and optimization for oral (tablets, capsules, solutions, suspensions) and injectable dosage forms. This includes operating various processing equipment (e.g., granulators, tablet presses, spray dryers) and applying analytical techniques (e.g., HPLC, DSC, TGA) to generate reliable data. The role also involves assisting in scaling up products from lab to GMP scale for clinical trial material, presenting findings to management and stakeholders, and documenting all data in compliance with GDP. The scientist will manage multiple projects, prioritize tasks, and ensure adherence to protocols, SOPs, and EHS guidelines for continuous improvement.
Responsibilities
• Lead the planning, design, and implementation of assigned research projects, integrating innovative methodologies and technologies to meet project goals.
• Collaborate with multidisciplinary teams to incorporate scientific insights into broader project objectives, ensuring alignment with development timelines and client requirements.
• Foster a collaborative and inclusive work environment, promoting knowledge-sharing and teamwork. Mentor and guide junior scientists to enhance team performance and skill development.
• Conduct formulation development and optimization studies for oral (tablets, capsules, solutions, suspensions) and injectable dosage forms. Focus on developing robust formulations for both small and large molecules.
• Operate various processing equipment (e.g., wet/dry granulation, fluid bed dryers, tablet presses, capsule fillers, spray dryers, hot melt extruders) and apply advanced analytical techniques (e.g., HPLC, DSC, TGA, SEM, XRD, dissolution) to generate high-quality, reproducible data.
• Lead the analysis, interpretation, and presentation of complex experimental data using statistical software and other data analysis tools. Ensure data integrity and quality.
• Lead the scaling-up process from laboratory scale to GMP scale for the production of clinical trial material, ensuring smooth transition and process validation.
• Prepare and review research protocols, updates, master batch records, development reports, CMC regulatory documents, and SOPs in compliance with regulatory and quality standards (e.g., FDA, EMA, ICH).
• Ensure all research activities comply with applicable regulatory requirements, quality standards, and industry best practices. Maintain compliance with GDP during data documentation.
• Perform laboratory work adhering to safety protocols, PPE utilization, and regulatory guidelines, ensuring safe work practices and environmental compliance.
• Effectively communicate complex scientific findings, technical concepts, and project status to both internal teams and external stakeholders (e.g., clients, regulatory bodies). Present research findings clearly and concisely.
• Manage multiple projects simultaneously, prioritize tasks, and meet deadlines. Provide regular updates on project status, risks, and milestones, contributing to project planning and scheduling.
• Stay up to date with the latest scientific advancements and industry trends. Lead the identification and integration of emerging technologies to improve research capabilities and efficiency.
• Actively participate in Environmental Health & Safety (EHS) discussions and initiatives, fostering a culture of safety and continuous improvement.
Qualifications
• Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field, with a focus on drug formulation or drug product development. Alternatively, a Master’s degree with significant relevant experience may be considered.
• Minimum of 3-5 years of hands-on experience in drug product formulation and process development, ideally within a CDMO or pharmaceutical environment.
• Expertise in the development of oral and injectable dosage forms, as well as familiarity with GMP and regulatory requirements.
• Strong experience in operating and troubleshooting various formulation and processing equipment (e.g., granulators, tablet presses, coaters, extruders, etc.).
• Knowledge of advanced analytical techniques (e.g., HPLC, DSC, TGA, SEM, XRD) and data analysis using statistical tools (e.g., Minitab, JMP).
• Strong communication skills, both written and verbal, with the ability to convey complex scientific concepts clearly.
• Proven ability to work independently and as part of a cross-functional team.
• Leadership skills with experience mentoring or coaching junior scientists.
• Excellent project management skills, including the ability to prioritize tasks, manage timelines, and meet deadlines.
• Track record of scientific success as measured by publications and presentations.
• Experience in working on and positively contributing to scientific teams.
• Ability to perform the physical requirements of the position.