Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.
Associate Director, Process Development
This position will support the development of novel active compounds within the Alkermes pipeline. Specifically, this position will provide strategic leadership for drug substance unit operations, scale-up and optimization in development from R&D to cGMP Phase 3 manufacture to process validation. Specific areas of focus include reaction engineering, crystallization and process modeling. The individual is expected to integrate QbD principles, guide experimental design with a focus on process understanding & robustness, interpret data, participate in cross-functional teams, write technical reports and mentor fellow engineers. The candidate should have strong communication & interpersonal skills, be able to multi-task and have a commitment to continuous learning. A solid background in chemical engineering is required.
Responsibilities include but are not limited to:
- Collaborate within cross-functional teams, specifically with Chemical and Analytical Development to define and execute development strategies that enable successful launch of Alkermes products.
- Implement scale-up strategies for drug substance synthesis and crystallization unit operations with a focus on process understanding, identification of critical process parameter and process optimization.
- Apply reaction engineering and process modeling in development activities. Identify and deploy new technologies as needed.
- Design crystallization processes that deliver solids of desired attributes
- Support technology transfer of drug substance unit operations and production at CMO(s)
- Integrate Quality Risk Management (QRM) and Quality by Design (QbD) principles into project activities in accordance with ICH Q9 & Q11
- Write technical reports and deliver presentations to technical, CMC and broader project groups.
- Author & review CMC sections of regulatory filing documents
- Mentor fellow engineers
Minimum Education & Experience Requirements:
- MS in Chemical Engineering with 15+ years of experience
- PhD in Chemical Engineering with 10+ years of experience
- Excellent written and oral communication.
- Experience in introducing, implementing and/or executing new chemical processes in pilot, commercial plants and/or contract manufacturing facilities
- Proven ability to apply scientific principles to design, execute and interpret experiments
- Experience in drug substance crystallization
- Pharmaceutical cGMP manufacturing experience
- Statistical design of experiment experience
- Team player with good interpersonal skills
Desired but not required
- PAT experience & chemometrics (e.g. ReactIR, Raman, FBRM)
- Experience with process modeling software (e.g., Matlab, Dynochem)
- Experience in working with DEA controlled substances
- Quality by Design experience
Personal Attributes Needed:
- Motivated self-starter
- Positive, adaptable, can-do attitude
- Ability to work independently
- Ability to travel and work flexible hours as required
- Functional ability to work in a pilot plant and commercial facility
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.