Principal Engineer

Alkermes

4d•Hybrid

About The Position

Join the Alkermes Process Development team as a Principal Engineer, where you will lead late-stage drug product Process Development activities at internal and external manufacturing sites. You will be responsible for providing technical guidance and driving execution for small molecule process development, scale-up and technical transfer to manufacturing from Phase 3 up to PPQ. You will play a key role in the CMC team and work closely with the Operations organization. This role will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs.

Requirements

PhD (>8 years’ experience) or MS (>15 years’ experience) in Science or Engineering
Expertise and demonstrated experience in small molecule process development, scale up and technical transfer.
Expertise in design of experiments, data analysis and data interpretation for process development studies.
Experience managing contract drug development (CDMO) activities.
Technical problem-solving ability utilizing current research and technologies.
Broad understanding of the drug development process and the role and impact of process development within this process
Demonstrated collaborative leadership, strong people skills, and excellent verbal and written communication skills.
Expert understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development.
Subject matter proficiency across a range of processing techniques such as, powder blending granulation, compression, encapsulation, Wurster coating and pan coating.
Demonstrated ability to work successfully in a fast-paced team/matrix environment as well as independently manage priorities and maintain timelines for multiple activities.

Nice To Haves

Previous experience with Process Analytical Technology is preferred.

Responsibilities

Provide subject matter expertise in process development methodologies at Alkermes requiring internal/external execution and technical oversight/supervision.
Guide and drive process development, design of experiments, product characterization and control strategy development for development programs.
Design and execute process development activities suitable for progressive stages of small molecule pharmaceutical development that follow ICH and FDA guidance.
Work closely with colleagues across Pharmaceutical Development and Manufacturing organizations to best leverage internal and/or external capabilities to assist in process development effort.
Provide timely technical support and management oversight of process development activities at external partners.
Develop, review, and approve process development source documents, and author and review drug product process development sections for regulatory submissions.
Present technical data to cross functional teams and senior management as a process development expert, and effectively communicate critical process issues and solutions.
Identify and advocate new and emerging technology opportunities for process development.
Manage, train and mentor junior Process Development staff.
Perform other duties as assigned.