Director of Drug Product R&D

Department: Drug Product Development R&D Location: Onsite, Cranbury NJ Job Type: Full Time Position Reports to: EVP Job Summary: The Director of Drug Product R&D will provide strategic and technical leadership for both Drug Product Development and GMP Manufacturing activities at Porton J-STAR. This role is responsible for establishing and managing drug product formulation and process development programs, overseeing GMP manufacturing operations for clinical and commercial supplies, and ensuring successful technology transfer from development to manufacturing. The Director will lead cross-functional teams to deliver high-quality drug product solutions while ensuring compliance with cGMP regulations, quality standards, client requirements, and business objectives. This position will play a key role in expanding the company's drug product development and manufacturing capabilities, driving operational excellence, and supporting client programs from early-stage development through GMP production. Responsibilities Establish drug product development system, including but not limited to procure, and installation of equipment, establish appropriate procedures for maintaining high standards. Support the GMP drug product manufacturing system. Manage the drug product R&D activities to ensure that all results and reports conform to the requirements of the established customer, project goal and company quality standards. Oversee and manage the end-to-end drug product development process, from formulation to manufacturing. Act as a key point of contact for clients, providing project updates, addressing concerns, and ensuring client satisfaction. Develop and maintain project timelines, budgets, and resource allocation plans. Provide technical leadership in the design and optimization of drug product formulations and processes. Evaluate and implement new technologies and methodologies to enhance drug product development capabilities. Review/approve protocols, updates, development reports, BMRs, SOPs, CMC regulatory documents & other quality documentation. Ensure adherence to regulatory guidelines and quality standards throughout drug product development. Collaborate closely with QC, QA, Maintenance & other groups to ensure timely formulation and process development, production & release of clinical trial materials. Identify, recommend, develop, and implement necessary changes, within the appropriate regulatory confines to improve productivity and for continuous process improvements. Adhere to EHS policies and maintain work areas in a safe, clean, and orderly fashion. Ensure the training program for all levels of R&D and manufacturing are current and complete, and production and R&D personnel are qualified to perform work assigned. Establish GMP drug product manufacturing system, including but not limited to qualify the facility, procure and perform IQ/OQ of equipment, establish appropriate procedures for maintaining high standards. Support drug product development R&D system, including but not limited to procurement of equipment and establishing appropriate procedures. Manage the manufacturing activities to ensure that all products conform to established customer and company quality standards. Ensure all GMP planning, manufacturing, cleaning, and storage operations run efficiently. Author/review/approve protocols, updates, development reports, BMRs, SOPs, CMC regulatory documents & other quality documentation according to regulatory guidelines. Work with R&D scientists and drug product GMP manufacturing team to ensure smooth technology transfer of R&D processes into the GMP manufacturing suites. Collaborate closely with QC, QA, Maintenance & other groups to ensure timely production & release of clinical trial materials. Lead root cause investigations, risk management, deviations, CAPAs as required. Identify, recommend, develop, and implement necessary changes, within the appropriate regulatory confines to improve productivity and for continuous process improvements. Adhere to EHS policies and maintain work areas in a safe, clean, and orderly fashion. Ensure the training program for all levels of manufacturing are current and complete and production personnel are qualified to perform work assigned. Ensure a rigorous preventative maintenance schedule is implemented and sustained for all GMP equipment and instrumentation. Qualifications Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field, with a focus on drug product manufacturing, preferably within a CDMO or pharmaceutical environment. Minimum of 10 years of progressive experience in drug product development and GMP manufacturing within the pharmaceutical, biotechnology, or CDMO industry, including management and leadership responsibilities. Ability to lead root cause investigations, manage CAPAs, and implement corrective actions to address manufacturing issues. Strong working knowledge of FDA, ICH, EU GMP, and other applicable regulatory requirements governing drug product development and manufacturing. Proven experience establishing and managing GMP manufacturing operations, including facility qualification, equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, and manufacturing readiness activities. Hands-on experience authoring, reviewing, and approving GMP documentation, including batch records, SOPs, protocols, investigations, deviations, CAPAs, change controls, and regulatory submissions. Experience leading technology transfer activities from R&D to GMP manufacturing and supporting clinical and commercial production programs. Strong understanding of pharmaceutical quality systems, risk management principles, data integrity requirements, and inspection readiness. Proven leadership experience managing multidisciplinary teams and collaborating effectively with QA, QC, Regulatory Affairs, Manufacturing, Engineering, and Client Project Teams. Excellent communication, client-facing, project management, and organizational skills. In-depth knowledge of regulatory guidelines, quality systems, and industry best practices. Strong communication skills, both written and verbal, with the ability to convey complex scientific concepts clearly. Leadership skills with experience mentoring or coaching junior scientists. Excellent project management skills, including the ability to prioritize tasks, manage timelines, and meet deadlines. Experience in working on and positively contributing to scientific teams. Ability to perform the physical requirements of the position. #J-18808-Ljbffr Porton Pharma Solutions Ltd.