Porton Pharma Solutions Ltd. · 1 day ago
Sr. Research Scientist (Drug Product)
Cranbury, NJ
Full-time
Onsite
Mid, Senior Level
3+ years expPorton Pharma Solutions Ltd. is seeking a highly motivated and skilled Research Scientist to join their Drug Product R&D Department. In this role, the scientist will lead formulation development and optimization for various dosage forms and manage multiple projects while ensuring compliance with regulatory standards.
Pharmaceuticals
Hiring Manager
孙于文
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
Qualification
Required
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
Company
Porton Pharma Solutions Ltd.
With over 4,200 employees and 18 operations and commercial offices across the US, EU, and China, Porton Pharma Solutions provides global pharmaceutical and biotech companies with innovative, reliable, and end-to-end process R&D and GMP manufacturing services across Small Molecules, Tides, Biologics and Conjugates (ADCs, AOCs, PDCs, RDCs, etc.), as well as Advanced Therapy Medicinal Products.
5001-10000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase