Job Description

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.

Position

Senior Analyst, QC Microbiology

Purpose and Scope of Position

The Senior Analyst, QC Microbiology, is responsible for routine and non-routine microbiological testing and environmental monitoring in support of sterile product manufacturing. The Senior Analyst is also responsible for peer review, training, supporting document management, projects, CAPAs and investigations in accordance with the organization’s policies, procedures, and state, federal and local laws and ensure compliance with current Good Manufacturing Practices (cGMP), USP, EP, JP and other regulatory requirements at all times.

Required Competencies:  Knowledge, Skills, and Abilities

• Advanced proficiency in MS Word, Outlook, and Excel programs as well as PowerPoint, Project and Visio.

• Advanced hands on experience with various microbiological testing techniques, environmental monitoring techniques and scientific knowledge.

• Advanced knowledge of how to conduct effective training and coaching of analysts.

• Intermediate ability to make and deliver formal presentations to internal and external audiences.

• Basic knowledge of electronic laboratory management systems.

• Strong attention to detail.

• Basic management and organizational skills.

• Basic team and individual leadership skills.

• Advanced understanding of relevant scientific and technical principles.

• Basic project management skills; capable of participating in departmental teams.

• Advanced knowledge of cGMP, USP, EP, FDA/PDA, OSHA and other regulatory guidance documents as relates to microbiological testing and environmental monitoring.

• Advanced written and verbal communication skills.

• Ability to develop detailed instructions accurately.

• Ability to gown and maintain a sterile work environment.

• Ability to work under limited supervision.

• Advanced GMP documentation skills.

• Advanced knowledge of laboratory safety practices.

• Ability to mentor peers on day-to-day tasks and more technical tasks; cooperative and works well with a team.

• Willingness to learn and share knowledge.

• Communicates effectively with peers, management and cross-functionally across the site.

• Intermediate knowledge of laboratory and aseptic processes.

• Ability to interpret / write complex business and technical documents.

• Advanced critical reasoning and decision-making skills for solving routine and complex problems that impact multiple departments.

• Ability to pass an initial full physical with annual monitoring.

• Ability to deal appropriately with regulatory agencies and act as a Subject Matter Expert (SME) for the department during regulatory and non-regulatory inspections.

Duties and Responsibilities

Performs routine laboratory and EM activities.

• Prepares schedules and sample labels.

• Performs tests such as (but not limited to) bioburden, BET, sterility, Growth Promotion, incoming media/reagent QC, BI testing.

• Operates laboratory equipment used to provide sterile and dehydrogenated materials.

• Read EM and testing plates and assess against alert and action levels as appropriate.

• Performs microbial isolation techniques, Gram stains and supports microbial identification process.

• Performs environmental monitoring activities in support of manufacturing.

• Collects utility samples for analysis.

• Maintain qualification status on aseptic gowning, sterility testing, BET, etc.

• Demonstrates aseptic technique when performing a Microbiological Test or EM.

• Perform testing/monitoring activities associated with protocols or special projects as required.

Perform peer review of testing data.

• Review all data in accordance with applicable procedures and cGMP requirements.

• Apply technical knowledge and abilities to ensure all testing is performed in a compliant matter.

• Complete all review in accordance with required timelines.

• Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.

Train new analysts to general job duties and specific testing and monitoring activities.

• Complete necessary training to become a qualified trainer.

• Perform training effectively.

• Document training per procedural and cGMP requirements.

• Determine training schedule and develop training content.

• Participate in hiring and onboarding processes of new analysts.

• Coach other analysts in troubleshooting microbiology methods, EM techniques and scientific equipment.

• Act as a mentor for other analysts, freely sharing knowledge and experience.

• Assists with developing best practices in the laboratory

Support management with day-to-day department activities

• Coordinates testing and monitoring activities within the QC lab and manufacturing facility.

• Ensure proper tracking of non-routine testing events.

• Follow up on testing execution with analysts, ensure communication to Laboratory Management.

• Responsible for tracking tools (EM batch release, sample trackers, etc.)

• Supports lab management in mid to long range capacity planning.

• Administrative tasks.

• Perform approval of laboratory data as required.

• Assist with allocation of resources, such as instrumentation and analyst availability.

• Assist analysts with questions and troubleshooting.

• Communicate effectively with management regarding more complex issues.

Support document revision, project, CAPA and investigation/deviation tasks.

• Perform assigned tasks within a CAPA, deviation or project.

• Participate in more complex projects and continuous improvement efforts.

• Take a leadership role on more complex projects.

• Draft and review technical documents, such as SOPs and protocols.

• Communicate effectively with management regarding task completion, roadblocks and needs.

• Assist in the development and implementation of corrective actions.

• Prepares written QC Microbiology trend reports.

• Determines impact of changes to QC department and supported GxP computerized systems.

Performs general laboratory duties as assigned.

 Education and Experience

• High School diploma or equivalent required.

• Bachelor’s Degree, particularly in Microbiology or Science related field, preferred.

• 3 years relevant work experience required, preferably in a manufacturing environment with cGMP requirement.

• An equivalent combination of education / experience may substitute.

Working Conditions

• The incumbent will be required to wear uniform/ PPE to work in a manufacturing, warehouse, or laboratory environment.
• The incumbent may be fully gowned for extended periods of time within a restrictive movement environment. This may include standing, bending, reaching, kneeling, etc.
• The incumbent will have to perform work in a controlled environment with strict glove and gown requirements.
• The incumbent will be required to maintain a safety alertness due to work around hazardous equipment and cytotoxic product.
• This position requires regular medical surveillance and may require incumbent to wear a respirator or gown.
• The incumbent must be able to distinguish colors and possess correctable vision to 20/20; annual eye exam is required.
• The incumbent may analyze data and work with spreadsheets and graphs on a daily basis.
• The incumbent may be working in a laboratory or manufacturing setting up to 6 hours per day.
• The incumbent must be able to lift/carry NMT 25 lbs.

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 BL

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. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

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 if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.