Manager, Quality Control Microbiology and Environmental Monitoring

Description

Purpose and Scope of Position

The Manager, QC Microbiology supervises and oversees the activities and personnel in the microbiology group as they perform routine EM (Environmental Monitoring) Sterility, Growth Promotion, EM plate reads, Endotoxin, Mycoplasma, and non-routine microbiological testing and activities to support Aseptic Process Simulations, In-process EM, EM Performance Qualifications, Gowning Qualifications, Aseptic Operator Qualifications and contamination control activities in support of CAR T manufacturing operations. Trends data, prepare metrics, reviews documents, reviews procedures, protocols/reports, support investigations and works on CAPAs. The Manager may be required to be hands on and perform lab tasks/testing as needed. The Manager performs responsibilities independently in accordance with the BMS’s policies, procedures, and state, federal and local laws and ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other regulatory guidelines/requirements at all times.

Required Competencies: Knowledge, Skills, and Abilities

• Ability to interact with regulatory agencies and internal auditors.
• Flexibility with working hours, ability to multi-task and work well under tight timelines.
• Advanced knowledge of current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory guidelines/requirements.
• Ability to interpret and write complex documents.
• Advanced written, verbal, and interpersonal communication skills.
• Advanced knowledge/experience with MS Word, Outlook, Excel, MS PowerPoint, Visio, LIMS.
• Advanced understanding of data integrity and good documentation practices.
• Strong problem-solving, troubleshooting skills, critical reasoning and decision-making skills.
• Strong organization and time management skills.
• Strong team spirit, work ethics and accountability.
• Able to develop and motivate others; delegate and solve routine problems.
• Ability to gown and maintain an aseptic work environment.
• Ability to prioritize tasks and escalate issues as required.

1. Duties and Responsibilities

• Mentor lab personnel as needed.
• Ensure employees assigned to tasks are properly trained.
• Complete performance evaluations and take additional action as needed.
• Support career development of direct reports.
• Foster a positive and inclusive work environment.
• Oversee personnel’s work schedule to ensure all assigned tasks are performed in a timely manner.
• Perform data review and additional laboratory activities when needed.
• Ensure laboratories remain in an audit ready state.
• Utilize scientific principles to assist in troubleshooting and problem solving for
• Support special projects.
• Serve as author and/or technical reviewer of departmental SOPs and other technical documents.
• Write and review protocols and reports.
• Communicate with department and cross-functional management.
• Perform other duties as assigned.

Requirements

• Education and Experience

• Bachelor’s degree required, preferably in Microbiology or a related science.
• 7-10 years’ relevant work experience required, preferably in a Quality Control Microbiology or Environmental Monitoring team in a pharmaceutical manufacturing environment with cGMP requirements. 
• Minimum of 1-2 years of people management experience required.
• QC Microbiology/EM experience is required.
• Cell and gene therapy experience preferred.
• Experience with Aseptic Process Simulations, EM Performance Qualifications, Gowning Qualifications and contamination control activities preferred.
• An equivalent combination of experience/education is acceptable.

1. Working Conditions

This position is a 10-hour second shift, Sunday – Wednesday role. The hours are approximately 1PM-11:30PM and may be adjusted to support manufacturing.  Candidate must be flexible, as hours and days of the week may change based on business needs.  Candidate must be available to work holidays, weekends as well as being available off hours to support business needs.  Initial onboarding/training will be during first shift hours until transitioned to second shift.

• This position may include standing, bending, reaching, kneeling, balancing, pushing, pulling, lifting or carrying (not more than 25lbs).
• This position requires concentrating, analytical thinking, working under tight timelines, decision making, and adapting to change.
• This position may require working within controlled environments with defined gowning requirements.
• This position requires working around magnetic fields and radio frequencies.
• This position requires additional gowning/PPE to work in manufacturing, warehouse, and laboratory environments.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

BMS is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  BMS complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for BMS in the U.S