Job DescriptionJoin 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.
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.
Qualifications- 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.
- Previous experience with Process Analytical Technology is preferred.
Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.
The annual base salary for this position ranges from $173,000 to $193,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
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