Principal Engineer, New Process Development

Job Description
THE COMPANY

Alkermes, Inc. is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression. Headquartered in Dublin, Ireland, Alkermes has an R&D center and US headquarters in Waltham, Massachusetts and manufacturing facilities in Athlone, Ireland, Wilmington, Ohio, and Gainesville, Georgia. For more information, please visit Alkermes’ website at www.alkermes.com.

POSITION SUMMARY:

Alkermes is seeking a senior-level engineer to lead a team of scientists and engineers in the development of new, small molecule clinical and commercial manufacturing processes.

ESSENTIAL AREAS OF RESPONSIBILITY:

The key duties of this role are to be the technical leader in the aspects of small molecule solid-state transitions, colloidal dispersions, and particle science. The role will also be responsible for CMC leadership of clinical and commercial scale-up efforts and to mentor colleagues in the areas of small molecule processing.

QUALIFICATIONS:

Minimum Education & Experience Requirements:

PhD in Chemical Engineering and 10+ years of experience preferred; MChE +15 years experience acceptable. Significant experience in organic crystallization is required.

Experience:
5+ years in the pharmaceutical industry with direct experience mentoring or directing scientist and engineers.
Experience in a Process Development environment using PAT and a fundamental understanding of Quality by Design methodology in developing GMP processes
Sterile and/or aseptic processing experience preferred but not required
Microencapsulation of APIs in biodegradable polymers experience preferred but not required

Technical Knowledge/Skills Needed:
Strong technical skills focused on fundamental understanding and optimization of unit operations such as crystallization, separations, drying and milling.
Experience using theoretical modeling to aid in fundamental understanding of diffusion, crystallization and drying.
A basic understanding of regulatory agency requirements, including but not limited to FDA, MHRA, EPA and OSHA.
Experience in technology transfers to commercial facilities
The ability to interact well with diverse groups, including R&D, Engineering, Validation, and Manufacturing; maintain collaborative working relationships with internal and external partners
Strong written and verbal skills to effectively communicate complex technical information to audiences of varied levels of experience and expertise.

Travel Requirements:
Occasional business travel expected

Company

Alkermes, Inc

Job Code

State or Province

Ohio

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