QC Microbiology Operations Manager

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Bristol Myers Squibb is seeking a Manager for QC Microbiology to join our Quality team in Devens, MA. This role will manage the daily operations of the QC Microbiology team, responsible for QC microbiology testing such as bioburden, endotoxin, identification, and data review for in-process and release testing of clinical and commercial biologics.  The Manager, QC Microbiology will also be responsible for hiring, mentoring, and developing the QC Microbiology team to support business operations and employee career development. 

Support for QC and manufacturing operations requires shift coverage during weekdays.  This position will directly manage both teams in the QC Microbiology group.

You will be onsite Monday – Friday, first shift. Specific working hours TBD with Candidate.

This role is stationed in Devens, MA and reports to the Senior Manager, QC Microbiology.

Qualifications and Education Requirements:

• Experience with microbiology assays and associated equipment.

• Experience with laboratory LIMS, ELN, and ERP systems (e.g., SAP) preferred.

• Ability to work in a highly regulated environment and follow regulatory requirements and GMPs.

• Ability to mentor associates, manage multiple assignments while meeting timelines in a GMP environment.

• Advanced ability to work collaboratively in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.

• Excellent organizational and critical thinking skills.

• Advanced problem-solving ability/mentality, technically adept and logical.

• Advanced ability to communicate effectively with peers, department management and cross-functional peers.

• Proficient with Excel, Visio, PowerPoint, and other common software applications.

• Bachelor’s degree required, preferably in Microbiology or related science.

• 6+ years of relevant laboratory work experience, in a regulated environment.

• 2+ years of management and people leader experience.

• An equivalent combination of education and experience may substitute.

Responsibilities:

• Supervise the QC Microbiology lab staff on shift (team of 12) and oversee the daily lab activities related to in-process, raw materials, stability, and final release testing of biologics drug substance for both commercial and clinical manufacturing facilities in a GMP environment.

• Develop and execute a work plan for the shift, ensuring safety, quality, and performance targets are achieved.

• Perform QC data review ensuring results are compliant with specifications and regulations.  Report abnormalities.

• Track, trend, and report key performance metrics.  Drive continuous improvement in the lab to increase productivity and efficiency.  May collaborate with other departments to identify and implement process improvements.

• Review and approve test methods and procedures to ensure operational alignment and compliance with corporate policies and procedures.

• Review and evaluate relevant change controls, investigations, deviations, CAPAs.

• Hire, mentor, and develop team members to support the business operations and employee career development.

• Administers departmental program to assure proper calibration and maintain laboratory equipment and leads the investigation and troubleshooting of equipment, testing and process abnormalities.

• Oversee training and scheduling of the team members.

• Communicate effectively with man