Lead Engineer I-Process Development 9/20/2017
JOB DESCRIPTIONAPPLY Company Overview:
Alkermes is a leader in innovative medicines that address the unmet needs and challenges of people living with debilitating diseases. Through our proven scientific, development and manufacturing capabilities, Alkermes is uniquely positioned to be an engine of innovative treatments for major clinical conditions specifically focused on central nervous system (CNS) disorders, such as schizophrenia, depression, addiction and multiple sclerosis.
Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts, as well as research and manufacturing facilities both in Athlone, Ireland and in Wilmington, Ohio. Currently an opportunity for a Lead Engineer I-Process Development is available at our Wilmington, Ohio facility. This rapidly expanding facility is within a 1-hour commute from the Cincinnati, Columbus, and Dayton metro areas.
For more information, please visit the Alkermes website at www.alkermes.com.
Alkermes is seeking an engineer to lead projects in support of small molecule clinical and commercial manufacturing processes. The individual will design, develop, scale-up and optimize robust drug product unit operations that provide high product quality at various scales ranging from R&D to cGMP manufacture. Strong collaboration is expected with internal early R&D groups, internal commercial partners, and external third party CMOs. The candidate should have strong communication & interpersonal skills, be able to multi-task and have a commitment to continuous learning.
ESSENTIAL AREAS OF RESPONSIBILITY:
The key duties of this role are to be the technical leader in late stage small molecule scale-up. The role will be responsible for commercial support of investigations and identifying process optimization opportunities within commercial operations.
* This role is expected to have a strong lab/pilot plant presence: design and execute statistical studies with a focus on process understanding & robustness, interpret and present data, participate in cross-functional development teams, and author technical reports.
* Utilize theoretical and practical expertise to troubleshoot and resolve technical issues with experimental studies or commercial operations.
* Identify and implement process improvements into on-going commercial operations with emphasis on yield improvement and reducing process variability.
* Generate documentation to support process design and implementation activities within a cGMP environment.
* Support FDA pre-approval and post-approval inspections by serving as technical expert for development and processing operations. Present, where appropriate, technical data to internal or external audit groups and commercial partners.
* Build strong relationships with internal and external stakeholders and take advantage of these relationships to identify new opportunities.
* Ensure all company and departmental policies and procedures are adhered to and follow cGMPs/cGLPs.
Minimum Education & Experience Requirements:
PhD in Chemical/Mechanical Engineering and 0-2 years of experience or MS degree and 3+ years of experience. Experience in development through cGMP commercial batch manufacture, and scale-up/optimization of pharmaceutical products is preferred.
* Experience in product development programs for early phase development through commercial validation/launch
* Experience in technology transfer of process to commercial facilities
* Demonstrated technical expertise for developing new and existing technology based pharmaceutical processes, ensuring a high level of technological competency
* 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
Technical Knowledge/Skills Needed:
* Demonstrated track record in generating technical options to resolve problems, prioritizing options to test, selecting optimal solutions based on available data, and implementing decisions
* Strong technical skills focused on fundamental understanding and optimization of unit operations such as drying, emulsions, crystallization, separations, and milling
* A basic understanding of regulatory agency requirements, including but not limited to FDA, MHRA, EPA and OSHA
* The ability to interact well with diverse groups, including R&D, Engineering, Validation, Quality Assurance, 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 technical expertise
* Demonstrated self-directed work habits and time management skills
* Computer skills: word processing, data processing, DOE, graphing and presentation
Occasional business travel
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.