Senior Development Scientist

Catalent • Greenville, NC

7d • Onsite

About The Position

Design, lead, and execute formulation and process development for early and late-stage pharmaceutical products, act as the primary client liaison for development and clinical manufacturing activities. Design, coordinate, and execute product development and technology transfer activities, including material characterization, excipient selection, prototype formulation, equipment selection, preparation of batch records and protocols, QbD implementation, and registration batch execution. Author essential documentation including batch records, protocols, development reports, risk assessments, and campaign summaries, and other technical documents that support product development history and CMC regulatory documents on behalf of our clients. Ensure that all formulation and development work is accurate, precise, properly documented and, when appropriate, performed within GXP guidelines and in accordance with oral solid dosage form processes. Manage project logistics, collaborate with suppliers, vendors, planners, and buyers to maintain sufficient inventory of raw materials. Partner with cross-functional teams—including analytical scientists, project managers, quality assurance, and commercial operations—to ensure timely and appropriate formulation and process development. Collaborate with quality and analytical teams to conduct thorough investigations including root cause analysis of quality events, impact assessments related to product quality events, and develop effective corrective and preventive actions (CAPAs). Train manufacturing operators on procedures and critical process parameters (CPPs), troubleshoot scale-up challenges, and support deviations, investigations, change orders, and CAPAs throughout product development stages. Perform risk assessments and determine QTPP/CQA, solve formulation and process problems related to excipient incompatibilities, and provide recommendations to clients for optimizing dosage form and manufacturing process (e.g., compression, encapsulation, granulation, and coating).

Requirements

• Master’s degree in Pharmaceutical Science
• 4 years of experience in job offered or 4 years of experience in the Related Occupation.
• Drive new formulation development projects for early and late stage development projects.
• Perform tech transfer activities and scalability studies (product compatibility study, bulk hold study, equipment selection, preparation of batch record, QBD implementation).
• Draft and review protocol, batch records, product development reports, summary reports, failure mode and effect analysis and tech transfer documents.
• Lead multiple normal paced and rush projects with minimal supervision ensure all technical aspects are accurate, precise, properly documented, reviewed and planned to meet timelines and milestones.
• Ensure material and resources planning with collaboration with internal supply chain team and external vendors ensuring sufficient inventory of raw materials for project.
• Collaborate with multi-disciplinary teams (Project Managers, Analytical Scientist, Quality Assurance and Manufacturing) and compile experimental and analytical results, perform data interpretation, summarize conclusions, recommend subsequent steps and provide scientific presentations to internal and external teams.
• Participate in troubleshooting and problem-solving initiatives for formulations, equipment and process for assigned projects including FMEA, root cause analysis, CAPA's, investigations and deviation.
• Provide on floor support and training to manufacturing operators on CPPs, ensure smooth tech transfer and successful production run.
• Participate in troubleshooting and problem-solving initiatives for formulations, equipment and process for assigned projects.
• Perform risk assessment on incoming project assessing Quality target product profile (QTPP), evaluating critical process parameters (CPPs) and its impact on (critical quality attribute (CQAs).

Responsibilities

• Design, lead, and execute formulation and process development for early and late-stage pharmaceutical products.
• Act as the primary client liaison for development and clinical manufacturing activities.
• Design, coordinate, and execute product development and technology transfer activities, including material characterization, excipient selection, prototype formulation, equipment selection, preparation of batch records and protocols, QbD implementation, and registration batch execution.
• Author essential documentation including batch records, protocols, development reports, risk assessments, and campaign summaries, and other technical documents that support product development history and CMC regulatory documents on behalf of our clients.
• Ensure that all formulation and development work is accurate, precise, properly documented and, when appropriate, performed within GXP guidelines and in accordance with oral solid dosage form processes.
• Manage project logistics, collaborate with suppliers, vendors, planners, and buyers to maintain sufficient inventory of raw materials.
• Partner with cross-functional teams—including analytical scientists, project managers, quality assurance, and commercial operations—to ensure timely and appropriate formulation and process development.
• Collaborate with quality and analytical teams to conduct thorough investigations including root cause analysis of quality events, impact assessments related to product quality events, and develop effective corrective and preventive actions (CAPAs).
• Train manufacturing operators on procedures and critical process parameters (CPPs), troubleshoot scale-up challenges, and support deviations, investigations, change orders, and CAPAs throughout product development stages.
• Perform risk assessments and determine QTPP/CQA, solve formulation and process problems related to excipient incompatibilities, and provide recommendations to clients for optimizing dosage form and manufacturing process (e.g., compression, encapsulation, granulation, and coating).

Benefits

• rewarding opportunities to further your career
• global drug development and leader
• helping bring over 7,000 life-saving and life-enhancing products to patients around the world
• exciting and growing international company
• employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market
• makes a difference
• personal initiative
• dynamic pace
• meaningful work

What This Job Offers

• Job Type: Full-time
• Career Level: Senior