SR Process Development Engineer
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POST DATE 9/7/2016
END DATE 1/5/2017
JOB DESCRIPTIONAlkermes 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 .
This position will provide technical leadership in the scale-up and optimization of drug substance unit operations at various scales ranging from R&D to cGMP Phase III manufacture. Specific areas of focus include reaction engineering, crystallization, process modeling and support for CMO activities. Strong collaboration is expected with internal R&D groups, internal commercial partners, and external third party CMOs. This role is expected to have a strong lab presence, design and execute experiments with a focus on process understanding & robustness, interpret data, participate in development teams and write technical reports. 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 develop processes for the manufacture of drug substance
* Develop and scale-up drug substance synthesis and crystallization unit operations with a focus on process understanding, identification of critical process parameter and process optimization
* Apply 'scale-down' approaches to model drug substance unit operations in a laboratory setting
* Design crystallization processes that deliver solids of desired attributes
* Apply reaction engineering and process modeling in development activities
* Support technology transfer of drug substance unit operations and production at CMO(s)
* Identify and deploy new technologies as needed.
* Integrate Quality Risk Management (QRM) and Quality by Design (QbD) principles into project activities in accordance with ICH Q9 & Q11
* Maintain instrumentation and laboratory process equipment.
* Write technical reports and deliver presentations to technical, CMC and broader project groups
* Author CMC sections of regulatory filing documents
Minimum Education & Experience Requirements:
* BS in Chemical Engineering with 12+ years of experience
* MS in Chemical Engineering with 8+ years of experience
* PhD in Chemical Engineering with 3+ years of experience
* Excellent written and oral communication.
* Experience in introducing, implementing and/or executing new chemical processes in pilot or commercial plants; experience with contract manufacturers is preferred.
* Proven ability to apply scientific principles to design, execute and interpret experiments
* Experience in drug substance crystallization
* Skilled in common analytical methods such as PXRD, TGA, DSC, HPLC, GC, GC/MS, FTIR, and UV
* Pharmaceutical cGMP manufacturing experience
* Statistical design of experiments
* 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 (~20%) 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.