Associate Director, Quality Control-Microbiology 8/19/2016
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, Ohio. For more information, please visit Alkermes website at www.alkermes.com .
The Associate Director of the Microbiology laboratory is responsible for all of the operations within the microbiology laboratory at the Wilmington, Ohio site. The successful incumbent will manage the environmental monitoring and finished product testing groups supporting the manufacturing of sterile parenteral injectable drug products. Additional responsibilities will include the disposition of microbiological and environmental testing results, responding to out-of-specification and out-of-trend test results, conducting laboratory investigations, identifying areas of process improvements, and other functions in order to maintain a high-throughput laboratory environment. Expertise in bioburden, endotoxin, TOC, sterility, microbial identifications and other related assays is required. The individual is expected to foster a team environment committed to quality and excellence. The incumbent is responsible for managing the performance of employees, temporaries, and contractors, to include involvement in processes such as objective setting, performance reviews, staffing, corrective action, succession planning, training and development, and other key human resource management activities. This individual will represent the Quality Control Microbiology department on cross-functional teams.
* Oversee department activities of 6-10 staff conducting Environmental Monitoring and supporting Bioburden, endotoxin, and sterility testing for raw materials, in-process materials, drug substances, and finished drug products
* Recognized at the Microbiology subject matter expert by exhibiting technical and theoretical understanding of microbiological methods
* Sound knowledge of cGMP and equivalent regulations
* Manages internal and external regulatory audits.
* Manage planning, preparation, and conduct of supervisors and staff performing a variety of routine and complex Quality Control tasks following cGMP regulations.
* Coach and develop staff by providing an environment that encourages ongoing personal and professional development. Manage and ensure the setting of realistic goals for staff and provide regularly scheduled feedback throughout the year. Ensure staff receives appropriate knowledge and skill development and growth opportunities.
* Evaluate and approve technical or investigation reports
* Review, evaluate and approve change records and trend reports
* Design and implement cGMP systems to correct deficiencies and develop staff expertise.
* Provide technical and managerial leadership to department staff through direct involvement.
* Contribute and represent department in CMC development teams and tactical operational teams.
* Provide guidance on the resolution of compliance issues, testing capacity, and Corrective and Preventative Actions (CAPA) as needed.
* Experience leading a Quality Control finished product testing group in the pharmaceutical industry with experience in parenteral and/or solid oral dosage forms preferred.
* Must be able to work in situations where speed and sustained attention are essential, performing a variety of tasks without loss of production.
* Prioritize tasks and responsibilities of laboratory employees.
* Communicate with internal customers and external clients.
* Accept responsibility for design and maintenance of cGMP laboratory systems.
* Accept responsibility for state of compliance for the microbiological laboratories, as applicable.
* Serve as a leader to teams of employees both within and between departments.
* Act as a successful team member in non-leadership roles.
* Develop, implement and manage achievements of results within budgets.
* Determine department goals consistent with Alkermes' strategy, develop plans to achieve those goals, and prioritize and execute those plans.
* Maintain open communications and promote teamwork and employee participation in the work group.
* Provide regular, appropriate feedback to subordinate personnel. Perform annual performance appraisals; co-create new goals and objectives; look for career developing opportunities when appropriate.
* Ability to lead and manage a team of individuals in the department to proactively achieve results for the best of the organization.
* Ability to function in a small company atmosphere.
* Ability to cope with a rapidly changing work environment.
* Commitment to teamwork.
* Commitment to continuous improvement in all areas.
* Ability to focus attention to details and ensure high quality work while maintaining the big picture to lead/drive whole organizational success.
* Ability to work safely; seek out and encourage safe practices.
EDUCATION AND EXPERIENCE:
* A Bachelor of Science or Master of Science with at least 10 years of pharmaceutical industry experience in the Microbiological laboratory, or 8 - 10 years of experience with a Ph.D. in a scientific related field.
* At least 5 years of experience in a leadership/managerial role in a cGMP laboratory
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.