Bristol Myers Squibb · 1 day ago
Senior Specialist, MSAT
Bothell, WA
Full-time
Onsite
Mid, Senior Level
$91K/yr - $110K/yr
5+ years expBristol Myers Squibb is a leading biopharmaceutical company that is transforming patients' lives through science. The MSAT (Manufacturing Sciences and Technology) team is responsible for managing deviation records and investigations to ensure compliance and quality standards are met.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Actively manages deviations to achieve RFT (right first time) and on-time phase completion, including deviation closure by the original due date
Immediately upon assignment of an investigation, partners with their investigation team (QA Reviewer/ Approver, SMEs [subject matter experts], and necessary stakeholders) on definition and alignment of the investigation plan, required data, and timing for completion. Continues to partner with investigation team throughout the investigation process to ensure agreement / alignment on root cause and CAPA
When CAPA are needed, facilitates the investigation / CAPA team to define objectives, deliverables, ownership, due dates, and effectiveness requirements
Ensures smooth transition of the defined CAPA to the owning department SME and ensures the CAPA progresses to implementation timely to ensure on-time deviation closure
Owns and investigates EM/PM trend deviations. Leads investigation team to perform deep-dive analysis of EM/PM trends, including to: Assess trend details to ensure accuracy and alignment across the team, Facilitate in-depth root cause analysis to determine additional process and system failure modes, Evaluate previous root causes and CAPA (in-progress or implemented) identified to lessen the trend, Determine if previous identified CAPA are sufficient to reduce the trend by defined targets
Leads GEMBAs and interviews the people closest to the work to identify failure modes and seek further understanding of the deviations
Applies HOP (Human and Organizational Performance) principles to investigations
Uses both soft-skills and technical skills to drive the deviation and CAPA processes: Demonstrates good teamwork, collaboration, and communication skills with all internal and external customers, Seeks to understand, demonstrates humility, and shows curiosity for learning, Completes deviations that are thorough, accurate, and complete, Understands the overall deviation and CAPA processes including all phases of the records and proper content for each phase, Understands appropriate assignment of classifications and requirements for each, Understands the importance and impact of lot association within deviations and the relation to product disposition, Captures the necessary data to support containment activities and impact assessment, Attaches all necessary supporting evidence to the electronic deviation and ensures all attachments have been referenced in the record, Performs investigations and root cause analyses that are commensurate to the event being investigated, Understands multiple RCA tools and when, where, and how to apply them, Utilizes good technical writing skills, Contacts vendor as needed to complete investigations in a timely manner, May participate on deviation governance teams, projects, and other initiatives
Qualification
Required
Minimum of Bachelor's degree in relevant Science or Engineering discipline and/or equivalent combination of work experience is required
5+ years of relevant cGMP experience
Proven ability to demonstrate attention to detail, personal and team accountability where it is critical to success
Expertise in GMP compliance and FDA/EMA regulations
Demonstrate excellence in written and verbal communication
Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
Innovative, proactive, and resourceful; committed to quality and continuous improvement
Ability to anticipate and mitigate challenges
Preferred
Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field
2 years working within quality systems managing deviation and CAPA records
Preferred Experience with microbiological techniques and/or environmental monitoring
Benefits
Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Paid Time Off
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2026-01-07
2026-01-07
2026-01-07
Company data provided by crunchbase