Director, QC Microbiology Operations

Bristol Myers Squibb
Phoenix, Arizona, US
Jul 01, 2021
Sep 09, 2021
Biology, Finance
Employment Type
Full time
Salary Type
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Director, QC Microbiology Operations directs the consolidated site functions of QC Microbiology and QC Microbiology Technical Services. The individual in this position is responsible for providing technical and scientific leadership to ensure the site is maintained in a state of microbiological control, is considered the site Microbiology SME, and is expected to provide guidance during critical investigations and internal / external regulatory inspections. To ensure a cohesive and aligned site operation, the individual in this role is expected to be part of the Site Leadership Team and partner, as necessary, with all departments at the site including Manufacturing Operations, Engineering Operations, Strategy and Business Operations, EHS, and all Functional Site Partners (Other Quality Operations, MS&T, Procurement, Supply Chain, HR, IT, Finance, and Security).
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- Extensive knowledge of aseptic pharmaceutical operations - preferably gained via experience leading a microbiology department responsible for multiple products, aseptic manufacturing and/or aseptic manufacturing technical support
- Extensive understanding of cGMPs, best manufacturing practices, regulatory health authority CMC requirements, EHS regulations & compliance
- Extensive knowledge of strategic planning, balanced scorecards, budgeting, scheduling, and microbiology best practices
Skills and Abilities
- Ability to connect and collaborate across internal and external organizations
- Ability to recruit, train, manage, and mentor a highly functioning, diverse, and effective team
- Ability to act independently and with minimal direction from Senior Director, Quality Operations
Critical Thinking and Problem Solving
- Ability to think creatively, critically, and strategically, and to solve problems in a complex global work environment with urgency and agility
- Ability and aptitude for analyzing data, detecting inconsistencies, determining relative importance, and utilizing data and risk analysis tools to manage competing priorities, need for results, compliance, and desire for continuous improvement
Teamwork and Collaboration
- A team player with the ability to influence others internally and externally in a matrixed organization
- Strong interpersonal and teamwork skills coupled with the ability to take risks and drive decisions that get results
- Demonstrated appreciation for and recognition of others, including peers, for exceptional performance
Professionalism and Strong Work Ethic
- Capable of successfully managing multiple projects and priorities in a responsive, professional, and customer service-oriented manner
- Willing to work irregular hours, rotating shifts, weekends, and holidays, as necessary however, strives to create an environment that provides an acceptable work/life balance
- Willing to travel as needed
Organization and Communication Skills
- Excellent verbal, written and presentation skills, command of communication and project management principles, techniques, and tools, i.e. Microsoft Project, Excel, PowerPoint, etc.
- Ability to escalate issues as appropriate, effectively plan and facilitate meetings, create action plans, and ensure completion with a well thought out path forward
- Ability to plan work schedules and set and adjust priorities
- Recruit, hire, train, manage, and mentor a diverse team of top talent to lead functional departments within areas of responsibility; and periodically update all Job Descriptions to appropriately reflect Senior Director, Quality Operations expectations that support a best-in-class operation
- Collaborate with peers, Senior Director, Quality Operations, and HR to ensure top talent and high performers have periodically updated development plans that include a variety of activities including, but not limited to, rotations, shadowing, special projects, participation in leadership programs or courses, and development opportunities to strengthen areas for improvement
- Take responsibility for personal development and ensure succession plans are in place for areas of responsibility
- Create and meet or exceed annual department goals, objectives and measurable metrics that support site and corporate vision, goals, objectives, and metrics; Ensure priorities are established and clearly communicated
- Create and adhere to department budget; collaborate with peers to redistribute funds as needed so overall site budget remains within expected range
- Ensure personal and personnel GMP, EHS, and Business qualification and training is completed on time
- Ensure department personnel have the tools and information available to perform their jobs safely and successfully
- Participate in and volunteer for at and above site technical teams, special projects, assignments, and steering committees as appropriate and always represent the site, yourself, and leadership team in a professional and positive manner; Serve as the key liaison with the global Micro Center of Excellence and Compliance Network
- Actively interacts and supports inspections and regulatory submissions
- Ensure deviations from procedures and specifications are investigated, resolved, and documented and CAPA's are identified and executed in a timely manner
- Notify management of significant issues in a timely manner
- Assure accuracy of Annual Product Review Microbiological elements
- Perform additional duties, including representing Senior Director, Quality Operations, as requested
- Lead areas of responsibility to carry out major duties and responsibilities as defined below:
QC Microbiology
- Oversee performance of the Environmental Monitoring (EM) and Aseptic Process Simulation (APS) programs required to support an aseptic manufacturing drug product facility
- Ensure EM and APS programs meet all applicable regulatory standards and are continually evaluated to incorporate best-in-class technologies
- Ensure EM and APS sampling and reporting is appropriate, thorough, completed in a timely manner, and required actions are taken to address any deviations, OOT and/or OOS results
- Oversee performance of all Microbiology drug product, utilities, and validation testing at the site for raw materials, in process, finished product, stability, utilities and cleaning
- Ensure testing meets all applicable regulatory standards and is continually evaluated to incorporate best-in-class technologies
- Ensure testing and reporting is completed in a timely manner
- Ensure procedures are scientifically sound, clear, accurately written, and followed
- Ensure trend reports are issued in a timely manner
- Support validation activities as required
QC Microbiology Technical Services
- Oversee all Microbiology related deviations and CAPA's at the site
- Partner with QC Microbiology to identify and execute opportunities for Continuous Improvement
- Ensure appropriate training is developed and delivered in a timely manner for all Microbiologists
- Partner with Knowledge Management as needed to ensure site personnel have appropriate knowledge and understanding of Microbiology principles as they relate to aseptic manufacturing of drug products
- BS in Microbiology, Biology, or equivalent
- PhD, MS, or MBA preferred
- Ten (10) years progressive managerial experience in one or more areas of microbiology, microbiology technical support, aseptic manufacturing support or regulatory agencies
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to Visit to access our complete Equal Employment Opportunity statement.
Company: Bristol Myers Squibb
Req Number: R1543199
Updated: 2021-09-05 03:11:26.675 UTC
Location: Phoenix,Arizona
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.