Process Development Engineer I
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POST DATE 8/30/2016
END DATE 11/19/2016
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 design, scale-up and optimize 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. The individual is expected to show 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.
* Work with partner groups, Chemical and Analytical development to apply chemical engineering principles in development. Apply 'scale-down' approach to model drug substance unit operations in a laboratory setting
* Support development, scale-up, technology transfer and ongoing production of chemical drug substance (API) processes
* Design and perform experiments in the lab to resolve technical issues observed during scale-up or manufacturing at large scale
* Apply reaction engineering, crystallization, and process modeling in development activities. Identify and deploy new technologies as needed.
* Plan and execute bench and documentation activities to ensure on-time development
* Transfer processes and process improvements from the laboratory to contract manufacturing facilities
* Maintain instrumentation and laboratory process equipment.
* Work with project teams consisting of process chemists, analytical chemists and pharmaceutical scientists to design crystallization processes that deliver solids of desired attributes.
* A Bachelor's Degree 2-4 years of Engineering experience or Master's Degree in Chemical Engineering with 2 years of experience is required.
* Experience in introducing, implementing and/or executing new chemical processes in pilot or commercial plants
* Process chemistry experience related to process development/characterization, technology transfer, , scale-up and/or manufacturing of chemical drug substance (API) processes in a cGMP environment
* Experience in working with contract manufacturers is preferred
* Advanced understanding of regulatory and cGMP requirements
* Solid understanding of process analytical technology and software (e.g. ReactIR, Raman, FBRM, Crystal16, Easymax) is preferred
* Experience using Design of Experiments methods for Process Development is preferred
* Experience with Process modeling software such as Matlab, Dynochem is preferred
* Experience in process development, experimental design, process safety assessment, reaction engineering, crystallization, and isolation development and evaluation.
* Experience in API final form definition; Crystallization kinetics ; Optimization of crystallization processes
* Demonstrate strong verbal communication, organizational, planning, problem-solving, and critical thinking skills
* Ability to work independently.
* Experience with DEA controlled substances is desired
* Skilled at analytical methods such as PXRD, TGA, DSC, HPLC, GC, GC/MS, FTIR, and UV
* This position may require up to 20% travel to contract manufacturing sites
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.