Bristol Myers Squibb · 1 day ago
Associate Director, Companion Diagnostics & Bioanalysis
Princeton, NJ
Full-time
Onsite
Lead/Staff, Director/Executive
$163K/yr - $197K/yr
8+ years expBristol Myers Squibb is a company that focuses on transforming patients' lives through science. The role involves leading the planning and operational execution of regulated laboratory activities to enable precision medicine, with a focus on Companion Diagnostics and bioanalysis under GxP principles.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Lead operational delivery of CLIA-based CDx initiatives support design input/output, analytical validation, tech transfer, and clinical deployment across IHC and complementary platforms (NGS, PCR, flow cytometry)
Drive design control rigor (risk management, traceability, DMR/DHR readiness) and partner with Regulatory/QA on submissions and audits
Integrate diagnostic strategies into clinical protocols to improve patient stratification and outcomes
Coordinate GLP-compliant bioanalytical programs (PK/PD/ADA) supporting clinical studies; oversee assay timelines, critical reagents, data transfers, and CRO deliverables
Ensure readiness for IND/IDE/PMA/510(k) touchpoints in partnership with Regulatory/QA
Embed FDA QMSR/21 CFR 820, 21 CFR 11, EU IVDR, ISO13485, CLIA/CAP throughout operations; maintain inspection-ready execution
Operationalize Good Documentation Practices (GDP) and ALCOA/ALCOA+ across sample, method, and data lifecycles; steward validated LIMS/ELN records and audit trails
Serve as the primary liaison for CROs, central labs, IVD/CDx manufacturers, and specialty vendors define scopes, SLAs, issue management, and quality/compliance expectations; ensure timely, patient-impacting delivery
Build transparent plans and own outcomes across scope, timeline, risk, and budget; forecast resources and shape capital investments in enabling platforms
Provide concise, patient-oriented updates to leadership; escalate risks early with data-backed mitigations
Model the BMS Behaviors-Urgency & Agility, Accountability, Innovation, and Passion for Excellence & Integrity-to create an inclusive, high-trust environment that delivers for patients
Rewiring BMS simplify interfaces, remove waste, and leverage AI-enabled, data-driven workflows to accelerate impact and decision-making in line with the enterprise change narrative
Qualification
Required
Bachelor's degree in scientific/engineering discipline required; MS/Ph.D. preferred
8+ years in GxP-regulated environments, including CDx/IVD development and bioanalysis in pharma, biotech, or CRO settings
Expertise in IHC (primary focus), with experience in NGS, PCR, and flow cytometry
Strong knowledge of FDA QSMR, GLP, CLIA, CAP, ISO13485, IVDR, and ICH-GCP
Experience with LIMS and electronic data management systems, ensuring compliance with GDP and ALCOA principles
Proven ability to manage complex projects, vendors, and cross-functional teams
Preferred
Previous experience at world-class diagnostic manufacturers in technology areas such as IHC, NGS, PCR, and flow cytometry, working under FDA QSMR (21 CFR Part 820), 21 CFR Part 11, EU IVDR, and ISO13485 requirements
PMP certification or equivalent preferred
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
MedCity News
2026-01-06
Dallas Morning News
2026-01-05
2025-12-30
Company data provided by crunchbase