Position Summary:Subject matter expert in bioanalytical techniques leading method transfer/validation and routine testing of in-process, final product, and stability samples. Conceptualize and lead complex projects, CAPAs, deviations, and continuous improvement efforts. Represent department in product review boards, regulatory inspections, and author responses to regulatory requests. Apply technical knowledge, regulatory requirements, and scientific principles to independently perform complex troubleshooting and problem solving.
Duties/Responsibilities- Subject matter expert in bioanalytical techniques (e.g., cell-based assays, ELISA, qPCR, flow cytometry) leading method transfer/validation and routine testing of in-process, final product, and stability samples.
- SME for training and mentoring team on multiple complex QC test methods, processes, and procedures.
- Independently develop, write, and execute methods, protocols, reports, and other related documents aligned with regulatory and corporate guidelines.
- Represent the department in product review boards, regulatory inspections (internal and external audits). Own and author responses to regulatory requests.
- Review and approve laboratory investigations.
- Champion and foster a positive and successful collaborative quality culture.
- Conceptualize and lead complex projects, CAPAs, deviations, and continuous improvement efforts.
- Own sections of APQR. • Represent QC interest on cross functional/ cross-site teams and communicate and collaborate effectively.
- Apply technical knowledge, regulatory requirements, and scientific principles to perform troubleshooting and problem solving for nonroutine complex issues.
- Perform other tasks as assigned.
QualificationsSpecific Knowledge, Skills, Abilities:
- Advanced ability to accurately and completely understand, follow, interpret and apply global regulatory and cGMP requirements.
- Demonstrated advanced technical writing skills.
- Advanced strategic thinking and problem-solving ability/mentality, technically adept and logical.
- Ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects.
- Advanced ability to communicate and collaborate effectively with peers, senior management and cross-functional peers about task status, roadblocks and needs, locally and globally.
- Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills. Education/Experience/ Licenses/Certifications:
- Bachelor's degree or equivalent required, preferably in science. Advanced degree preferred. Netherlands: PhD in (bioanalytical) science preferred. Bachelor's degree in (bioanalytical) science with equivalent combination of work experience may be considered.
- 10+ years of relevant analytical testing, including 2+ years of QC experience, or an equivalent combination of education and experience.
- Expert scientific knowledge with a broad range of bioanalytical techniques (cell-based assays, ELISA, qPCR, flow cytometry) and deep expertise with the characterization, validation, and transfer of bioanalytical methods.
We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:Devens - MA - US: $124,590 - $150,977
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We WorkWhere you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
