Alkermes 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 is a growth position, responsible for managing the Kilo Lab facility for process development and scale-up activities associated with manufacture of non-GMP and Phase 1 GMP intermediates and drug substances. This position will be a key member of Chemical Development, focusing on developing and optimizing safe, scalable, and operationally efficient processes for drug substance manufacture. The individual in this position will enhance the scientific capabilities of the department by serving as a resource of technical expertise regarding scale-up and Kilo Lab operations. This position requires excellent collaboration and communication skills while working with Analytical, Process Development, Quality Assurance, Facilities and EHS functions to move programs forward.
Lead and manage day-to-day operations of the Chemical Development Kilo Lab facility, with responsibility for non-GMP and Phase 1 GMP manufacturing activities:
Manage Kilo Lab facility planning and scheduling
Ensure facility and equipment operations, cleaning, and maintenance are completed as required and compliant with relevant SOPs
Maintain and control inventory of raw materials, starting materials, intermediates, and final drug substance associated with the Kilo Lab facility
Develop and track performance metrics for Kilo Lab operations
Collaborate with Quality Assurance, Facilities and EHS department partners:
Oversee and maintain quality and safety requirements for the Kilo Lab facility (e.g. SOPs, training)
Coordinate equipment calibrations and PMs
Serve as a key member of the PHA team to ensure that activities performed in the Kilo Lab facility meet process safety requirements
Apply cGMP principles for Phase 1 clinical studies by following internal SOPs and remain current with regulatory practices.
Develop and implement strategic plans for the Kilo Lab facility regarding operations and equipment.
Develop and manage capital and expense planning budgets for Kilo Lab facility
Supervise technical staff in a matrix organization
Provide guidance and oversight to all chemist and engineering staff who utilize the Kilo Lab facility, establishing and leading best practices for operations and activities.
Author and review technical reports
EDUCATION AND EXPERIENCE:
MS in Chemistry or Chemical Engineering with 10+ years relevant experience
Previous Kilo Lab, pilot plant or plant experience preferred
Established track record in scale-up of safe, effective processes for manufacturing drug substances
Strong oral and written communication skills.
Strong leadership qualities, with the ability to lead and influence technical teams and mentor less experienced scientists and engineers
Desire to collaborate and foster a culture of safety and operational excellence
Deep understanding of process chemistry and engineering principles
High level of technical knowledge of plant equipment and capabilities
Significant knowledge of cGMPs and applicable regulatory guidance
Demonstrated capability to effectively manage technical details and solve technical problems
Ability to interact and collaborate within an interdisciplinary team environment on creative problem solving
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.