Principal Engineer/Scientist-Process Development 9/9/2016
JOB DESCRIPTIONAPPLY 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, and Wilmington, OH. For more information, please visit Alkermes website at www.alkermes.com .
The positions serves as the sites Oral Solid Dosage (OSD) platform leader and reports directly to the Sr. Director of Process Development. Responsibilities include management and oversight of multiple early and late stage development projects and support personnel.
* Demonstrates technical expertise in OSD technology and methodologies.
* Lead site related process development, scale-up, commercialization and tech transfer responsibilities
* Collaboratively develop project strategies to meet CMC objectives including design, write and oversee execution of development protocols to support project related activities. Conclude activities with appropriate technical reports to support regulatory submissions
* Provide leadership to a team of engineers, and technicians supporting Process Development and Clinical Manufacturing activities.
* Communicate project status to department and site heads via written and oral communications.
Experience and Skills:
* Experience as a CMC or technical leader prioritizing and managing experimental strategies and communications to senior leadership.
* Knowledgeable and proficiency in the design and manufacturing of OSD forms at development and commercial scales
* Technical background in Formulation and Process Development of solid dosage forms, specifically; wet/dry granulation, direct compression (single and bilayer) and pan coating.
* Knowledge in effective strategies to develop, scale-up and transfer complex R&D processes to Clinical and Commercial Manufacturing.
* Working knowledge of Quality by Design and industry trends with Process Analytical Technologies
* Strong problem solving and analytical skills
* Working knowledge of statistics; classical, experimental al designs, and process controls
* Excellent verbal and written communication skills with experience communicating both up and down the organization. Strong technical report writing experience is required.
* The desire to work in small, collaborative technical groups in a dynamic, fast-paced, work environment.
* PhD and 8+yrs, MS and 15+yrs, BS and 20+yrs experience in area of oral solid dosage pharmaceuticals industry with a degree in Engineering or a related field of study
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.