Senior Development Scientist

Catalent•Greenville, NC

About The Position

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.

Requirements

Requires a 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
Serve 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.