Scientist, Site Microbiology, Cell Therapy
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.
Bristol Myers Squibb is seeking a Site Microbiology Scientist at the Cell Therapy Facility (CTF) in Devens, MA. The Site Microbiology scientist is responsible for supporting contamination control initiatives in QC Microbiology and cGMP manufacturing. This includes the ability to interface with multiple groups, be a subject matter expert (SME) on microbiology and cleanroom manufacturing control, and represent site microbiology for the CTF during regulatory inspections. Additionally, the Site microbiology scientist will perform environmental monitoring (EM) trending, participate in environmental action committees, and act as SME on deviations and investigations related to contamination and cleanroom control. The Site Microbiology scientist is stationed in Devens, MA and reports to the Site Microbiologist for the Devens CTF.
- Represent site microbiology and contamination control to internal and external parties.
- Perform risk assessments of cleanroom manufacturing processes to identify contamination control risks and establish EM site placement.
- Compile data on contamination control findings to present during environmental action committee (EAC).
- Participate in investigations related to contamination control and EM excursions.
- Perform data analytics on EM Trending and prepare trend reports for review and approval by cross functional stakeholders.
- Perform cleanroom walkthroughs and mentor/teach staff on best practices for contamination control.
- Anticipate and troubleshoot problems.
- Train new scientists on site microbiology activities.
- Become a qualified trainer on assigned tasks and deliver training to scientists, documenting training per procedural and cGMP requirements.
- Support document revision, project, CAPA, and investigation/deviation related tasks.
- Perform assigned tasks within a CAPA, deviation, or project.
- May lead projects and continuous improvement efforts.
- Other duties as assigned.
- Support for QC and manufacturing operations requires shift coverage consisting of weekdays, weekends, holidays, and during adverse weather conditions.
- This position works the following shift schedule:
- Monday to Friday 8 AM - 5 PM
Qualifications and Education Requirements
- Bachelor’s degree required, preferably in Science.
- 7+ years of relevant work experience, preferably in a regulated environment.
- An equivalent combination of education and experience may substitute.
- Experience working in a GMP laboratory, preferably with cell therapy products.
- Knowledge of aseptic technique in cGMP and Laboratory environments.
- Hands on experience in EM methodology preferred.
- Knowledge and experience with regulations regarding cGMP manufacturing of sterile drug products, including advanced therapy medicinal products (ATMP).
- Experience with various data analytics, document control systems, and technical reporting.
- Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
- Strong technical writing skills.
- Strong problem-solving ability/mentality, technically adept and logical.
- Ability to represent the interests of the group on cross-functional teams.
- Strong ability to communicate effectively with peers, department management and cross- functional peers.
- Working knowledge of data analysis systems, document control systems, and quality management systems is highly desirable.
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.
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