Associate Scientist/Sr. Specialist, QC Microbiology Trainer

Regulatory Jobs

Bend (OR)

In loco

USD 85.000 - 103.000

Tempo pieno

2 giorni fa
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Vantaggi offerti da questo lavoro

Comprehensive benefits
Flexible work options

Descrizione del lavoro

Bristol Myers Squibb seeks a Sr. Specialist, Associate Scientist, QC Microbiology Trainer to support qualification and ongoing development of personnel performing microbiology and environmental monitoring in the Cell Therapy QC laboratories.

You will deliver instructor-led and hands-on training using approved curricula, coordinating with QC SMEs and site training to ensure compliant, well-documented programs.

Competenze

  • Strong knowledge of QC microbiology laboratory operations.
  • Solid understanding of aseptic technique and microbial controls.
  • Familiarity with cGMP requirements and pharmaceutical regulations.
  • Experience training, coaching, and mentoring laboratory personnel.
  • Proficient technical writing and training documentation.

Mansioni

  • Deliver instructor-led and hands-on training for QC microbiology and environmental monitoring methods.
  • Qualify and mentor analysts on laboratory methods and aseptic practices.
  • Coordinate training schedules with QC management and subject matter experts.
  • Develop and revise training curricula, job aids, and assessments.
  • Ensure training materials and records comply with procedures and cGMP.
  • Support investigations, CAPAs, and continuous improvement in training.

Conoscenze

QC microbiology
Aseptic technique
cGMP knowledge
Training delivery
Document control

Formazione

Bachelor's degree in microbiology/biology
Related lab/training experience

Descrizione del lavoro

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

The Sr. Specialist, Associate Scientist, QC Microbiology Trainer is responsible for supporting the qualification and ongoing development of personnel performing microbiology and environmental monitoring activities within the Cell Therapy QC laboratories. This role develops, coordinates, and delivers instructor-led and hands‑on laboratory training using approved curricula, procedures, and qualification materials. The trainer partners with QC subject matter experts, laboratory management, and the site training organization to schedule training, maintain training laboratories and materials, monitor qualification progress, and ensure that training is documented in accordance with applicable procedures and cGMP requirements. The successful candidate will combine strong QC microbiology knowledge with effective facilitation, coaching, technical writing, and organizational skills to promote a compliant, consistent, and effective learning environment.

Shift: Sun - Wed 6:30am to 4:30pm

Key Responsibilities
  • Deliver instructor‑led, hands‑on, and on‑the‑job training for QC microbiology and environmental monitoring methods.
  • Qualify and mentor analysts on approved laboratory methods, procedures, aseptic practices, and applicable training requirements.
  • Coordinate training schedules with QC management, laboratory personnel, qualified trainers, and subject matter experts.
  • Support the development, revision, and periodic review of training curricula, qualification plans, presentations, job aids, assessments, and training materials.
  • Ensure training is delivered and documented in accordance with approved procedures, curricula, and training materials.
  • Support microbiology and environmental monitoring training for techniques that may include:
    • Aseptic technique
    • Environmental monitoring
    • Sterility testing
    • Endotoxin testing
    • Gram staining
    • Growth promotion
    • qPCR
    • Other applicable microbiology methods
  • Maintain the microbiology and aseptic training laboratories, including equipment, supplies, training samples, and instructional materials.
  • Facilitate initial, refresher, remedial, and continuing qualification training based on departmental needs.
  • Support the evaluation of trainee knowledge and practical performance, and provide timely, constructive coaching.
  • Track training activities, qualification progress, completion status, and applicable training metrics.
  • Identify training gaps, recurring challenges, and opportunities to improve training effectiveness, laboratory readiness, and Right‑First‑Time performance.
  • Author, review, and revise training documents, technical procedures, test methods, and other controlled documentation as assigned.
  • Review training and laboratory documentation for completeness, accuracy, and compliance with applicable procedures and cGMP requirements.
  • Maintain appropriate control and filing of training records and supporting documentation.
  • Work collaboratively with QC Microbiology, Environmental Monitoring, Quality Assurance, site training, and other cross‑functional partners.
  • Support training‑related investigations, deviations, CAPAs, continuous improvement efforts, and inspection‑readiness activities, as assigned.
  • Represent QC Training during internal audits, regulatory inspections, and cross‑functional discussions when needed.
  • Cross‑train on additional QC laboratory methods or processes to expand training coverage.
  • Promote a strong learning culture that supports technical proficiency, compliance, accountability, and continuous development.
  • Perform other job‑related duties as assigned.
Required Qualifications
Education and Experience
  • Bachelor’s degree in microbiology, Biology, Biological Sciences, or a related scientific discipline with relevant QC, microbiology, laboratory, or training experience.
  • An equivalent combination of education, laboratory experience, and technical training may be considered.
  • Relevant experience in a pharmaceutical, biotechnology, cell therapy, or similarly regulated laboratory environment.
  • Hands‑on experience with QC microbiology, environmental monitoring, aseptic practices, or related laboratory methods.
  • Experience training, coaching, qualifying, or mentoring laboratory personnel.
  • Experience working within cGMP and applicable regulatory requirements.
Knowledge, Skills, and Abilities
  • Strong working knowledge of QC microbiology laboratory operations.
  • Strong understanding of aseptic technique and microbiological controls.
  • Knowledge of cGMP requirements and pharmaceutical or biotechnology regulations.
  • Ability to learn, perform, demonstrate, and teach laboratory methods consistently using approved procedures.
  • Ability to translate complex technical information into clear and practical training.
  • Strong presentation, facilitation, coaching, and interpersonal skills.
  • Effective technical writing and documentation skills.
  • Strong planning, organization, prioritization, and time‑management skills.
  • Ability to manage multiple training assignments and time‑sensitive deliverables in a fast‑paced environment.
  • Strong attention to detail and commitment to accurate, complete, and compliant documentation.
  • Ability to communicate training status, qualification risks, roadblocks, and support needs effectively.
  • Demonstrated problem‑solving skills and the ability to address both routine and complex training challenges.
  • Ability to work independently while collaborating effectively with cross‑functional teams.
  • Customer‑focused mindset with a commitment to meeting trainee, laboratory, and stakeholder needs.
  • Ability to provide constructive feedback and create a supportive learning environment.
  • Proficiency with applicable learning management systems and standard business applications is preferred.
Preferred Qualifications
  • Experience with environmental monitoring, sterility testing, endotoxin testing, Gram staining, growth promotion, qPCR, or other applicable microbiology methods.
  • Experience developing laboratory curricula, qualification plans, assessments, presentations, or hands‑on training materials.
  • Experience supporting training metrics, qualification tracking, or training‑effectiveness evaluations.
  • Experience with laboratory information management systems or electronic learning management systems.
  • Experience supporting deviations, investigations, CAPAs, audits, or regulatory inspections.
  • Experience within a Cell Therapy QC environment.
Working Conditions
  • The position requires regular work in a laboratory environment.
  • The role may involve working around biological materials, biohazardous materials, and chemical agents while following established safety procedures.
  • The position requires the ability to demonstrate laboratory techniques and facilitate hands‑on training.
  • Schedule flexibility may be required to support laboratory operations, training demand, and urgent business needs.

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:

Summit West - NJ - US: $40.97 - $49.64per hour

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 Work

Where 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.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo‑accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california‑residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud‑protection.

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

If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.com with the Job Title and Requisition number. Do not send application‑related inquiries to this email.

R1607383 : Associate Scientist/Sr. Specialist, QC Microbiology Trainer

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