Senior Development Scientist

Catalent • Greenville, NC

2d

About The Position

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where 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. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.

Requirements

• Master’s degree in Pharmaceutical Science
• 4 years of experience in job offered or 4 years of experience in the Related Occupation.
• Designing, coordinating, and executing all product development activities including material characterization, excipient selection, prototype manufacture, equipment selection, generation of batch records/protocols, scale-up, QbD, and registration batch activities.
• Writing all the required documentations including batch records, protocols, product development reports, risk assessments, and campaign summaries.
• Managing the projects and working with suppliers/vendors, logistics and planner/buyers to help ensure that an adequate inventory of raw materials is maintained at all times.
• Working closely with analytical scientists, project management, quality, and commercial operations to ensure that formulation and process development are appropriate and timely.
• Collaborating with quality and analytical groups in performing robust quality event investigations and proposing sound CAPAs.
• Trouble shooting manufacturing scale up issues during different stages of product development.
• Maintaining competence and training documentation for relevant equipment and processes.

Responsibilities

• Lead and support formulation and process development activities while serving as a primary point of contact with the client regarding pharmaceutical development and clinical manufacturing project related activities.
• Design, coordinate, and execute all product development activities including material characterization, excipient selection, prototype manufacture, equipment selection, generation of batch records/protocols, scale-up, QbD, and registration batch activities.
• Write all the required documentations including batch records, protocols, product development reports, risk assessments, and campaign summaries.
• Manage the projects and work with suppliers/vendors, logistics and planner/buyers to help ensure that an adequate inventory of raw materials is maintained at all times.
• Work closely with analytical scientists, project management, quality, and commercial operations to ensure that formulation and process development are appropriate and timely.
• Collaborate with quality and analytical groups in performing robust quality event investigations and proposing sound CAPAs.
• Trouble shoot manufacturing scale up issues during different stages of product development.
• Work with schedulers to design an efficient schedule of equipment and resources to minimize machine down times and maximize usage of high demand equipment.
• Maintain competence and training documentation for relevant equipment and processes.

What This Job Offers

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