Manager, Process Development

Alkermes•Wilmington, OH

2d•$165,000 - $170,000

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 varied processing capabilities and technologies, serves as a subject matter expert on processing equipment, and provides technical guidance and training. It leads selection of process trains and flows, designs and executes experiments, and manufactures GMP batches at multiple scales. The position leads science-driven process development activities to build process understanding and achieve robust, repeatable control. It selects appropriate parameters for prototype and finished dosage production to ensure product quality and reproducibility, and manages systematic process development and technology transfer activities. The role also creates and controls procedures and systems, including batch records, change controls, and standard operating procedures, with a focus on efficiency and continuous improvement. Responsibilities include preparing, reviewing, and approving protocols, reports, and regulatory submission sections; maintaining compliance with cGMP, safety and environmental legislation, and company policy; presenting technical data and communicating process issues and solutions to cross-functional teams and senior management; and managing, training, and mentoring 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 designing experiments and conducting data analysis and interpretation for process development studies.
Ten years of experience in technical problem-solving using 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 requirements 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 technologies.
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.
Lead science-driven process development activities to create well-understood products and processes at all scales with robust and repeatable control.
Select appropriate parameters for prototype and finished dosage production to ensure 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.