Microbiology Lab Supervisor provides technical and supervisory leadership and mentoring to Microbiologists and provides support to management. Directs, coordinates, and evaluates the activities of QC Microbiologists in the PTS group. Must have well experienced in Microbial Testing of finished products, raw materials and in process samples associated to sterile and non-sterile drug product manufacturing per global pharmacopeia. Also, the person must have knowledge of U.S. Food and Drug Administration regulations and other regulatory agencies.
Responsibilities:
Responsible and supervising all Microbiologists, coordinating the daily laboratory operation, lab supply purchasing, and laboratory projects.
Responsible for reviewing and approving laboratory work and issuing JSR for product release.
Assigns duties and responsibilities to Microbiologists and tracking the product release schedule.
Coordinates product release activities with QC analytical, supply chain and Quality Assurance department
Review/approval of microbiological test results using LIMS.
Maintains GMP/GLP laboratory logbooks and documentation relevant to the duties and responsibilities assigned.
Prepares and/or reviews trending reports for quality control testing as required.
Participates in quality audits and inspections to ensure compliance.
Trends data, prepare metrics, reviews documents, writes procedures, protocols/reports, performs investigations and works on CAPAs.
Performs Out of Specification (OOS) investigations, Non-Conformance (NC) investigations, and Corrective Action / Preventative Actions (CAPA).
Provides staff with leadership, support, and mentoring. Conducts performance reviews for direct reports, holds regular team meetings, and provides training to employees as needed.
Good understanding of LIMS workflow and able to support generation of specific LIMS template in compliance with GAMP requirements
Education/ Experience:
BS degree in Microbiology, Biology or related scientific field required.
10+ years' relevant experience within the biopharmaceutical industry with experience in biotechnology and aseptic processing required.
1+ years of leadership experience or demonstrated leadership role preferred.
Preferred Qualifications:
Demonstrated knowledge of Pharmacopeia, GMPs, FDA and other regulatory requirements is required.
Quality Systems experience desirable.
Advanced knowledge of microbiology methods and testing required.
Must have strong written and verbal communication skills. Must be able to effectively present at staff and department meetings.
Knowledge of MS Office Suite.
Flexibility with working hours, ability to multi-task and work well under tight timelines.
Ability to work independently and in a team environment.
Excellent leadership skills.
Excellent communication skills.
Excellent organizational skills.
Skilled in problem solving techniques including the ability to work closely with peers and other departments to identify and solve complex technical, product and production related issues.
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, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
