Senior Development Scientist

Job Title:

Senior Development Scientist

City:
Greenville

State: NC

• 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.

Requires a Master’s degree in Pharmaceutical Science and 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.

Full Time

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to Disabili This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration to the application or hiring process.