Manager, Process Development

Alkermes•Wilmington, OH

About The Position

The Manager, Process Development manages development, scale-up, optimization, and transfer of robust manufacturing processes for solid oral dosage forms. The role operates GMP manufacturing suites with a broad range of processing capabilities and technologies, and serves as a subject matter expert on processing equipment and technical matters. It designs and leads process trains and process flows, experiments, and process development activities to build science-driven process understanding and achieve robust, repeatable control at all scales. The position manages systems and procedures for its area of responsibility, including batch records, change controls, and standard operating procedures, with an emphasis on efficiency and continuous improvement. It selects parameters for prototype and finished dosage production to support product quality and reproducibility, and manages systematic process development and technology transfer activities to ensure consistency and quality. The role also prepares, reviews, and approves protocols, reports, and regulatory submission sections; maintains compliance with cGMP, safety and environmental legislation, and company policy; communicates technical data and process issues to cross-functional teams and senior management; and manages, trains, and mentors junior Process Development staff.

Requirements

Bachelor’s degree in Pharmaceutical Manufacturing, Chemical Engineering, or a related field.
Ten years of experience in pharmaceutical solid oral dosage processing.
Ten years of experience with processing techniques including powder blending, granulation, compression, and coating.
Ten years of experience in small molecule process development, scale-up, and technical transfer.
Ten years of experience in design of experiments, data analysis, and data interpretation for process development studies.
Ten years of experience in technical problem-solving utilizing research and technologies.
Ten years of experience with the drug development process.
Ten years of experience applying ICH, FDA, and USP guidelines in stages of drug development.
Ten years of experience in drug product formulation. Experience may be gained concurrently.

Responsibilities

Manage process development activities to develop, scale up, optimize, and transfer robust manufacturing processes for solid oral dosage forms.
Operate GMP manufacturing suites with a broad range of processing capabilities and technology approaches.
Serve as a subject matter expert on processing equipment, assimilate and use new technologies, and provide technical guidance, training, and direction.
Design and lead selection of process trains and process flows.
Design and execute experiments to enhance process understanding and manufacture GMP batches at various scales.
Create, manage, and control systems and procedures, including batch records, change controls, and standard operating procedures, with a focus on efficiency and continuous improvement.
Design and lead process development activities that develop science-driven products and processes at all scales, achieving robust and repeatable control.
Select appropriate parameters for prototype and finished dosage production to achieve product quality and reproducibility.
Manage systematic process development and technology transfer activities to ensure consistency and quality of developed processes.
Prepare, review, and approve protocols, reports, and sections of regulatory submissions.
Maintain compliance with cGMP, safety and environmental legislation, and company policy.
Present technical data to cross-functional teams and senior management, and communicate critical process issues and solutions.
Manage, train, and mentor junior Process Development staff.