Specialist, QC

Working with Us
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Job Description

Bristol-Myers Squibb is seeking a quality control professional to join our QC Bioseparations team, performing QC testing in support of biologics bulk drug substance manufacturing and Stability Studies using defined methods in a cGMP compliant laboratory. The QC Specialist assures test results are accurately recorded and abnormal data or equipment/instrument malfunctions are promptly reported to supervisors. The QC Bioseparations team works day shifts Monday through Friday.

Major Duties and Responsibilities

• Performs routine testing and data review of in-process, batch release and stability samples of Bulk Drug Substance and Drug Products in a cGMP compliant environment.

• Executes routine procedures based on methodologies/responsibilities of the QC Bioseparations laboratory.

• Author revisions to SOPs for managerial review and approval.

• Trained on multiple methodologies, and provides support to a broader spectrum of testing responsibilities Executes troubleshooting techniques with guidance of supervisor or senior team members.

• SME on specific methodology.

• Trainer for specific methodology, responsible for training less experienced analysts on assays of expertise

• May support qualification and validation testing for QC methods in area of expertise May lead investigations for the team.

Education, Knowledge and Skills

• Knowledge of science generally attained through studies resulting in a BS in the physical or life sciences, a related discipline, or the equivalent in related experience.

• A minimum of 4 years relevant experience in a cGMP Biologics QC laboratory or equivalent in related laboratory environment.

• Demonstrated experience with basic laboratory techniques such as pH, UV-Vis, volumetric measurement, pipetting, analytical weighing, and basic laboratory safety practices.

• Prior experience in HPLC/UPLC, SDS-PAGE, iCIEF, or Capillary Electrophoresis (CE) .

• A working knowledge of regulatory standards as they apply to GMP laboratories. 

• Attention to detail and demonstrated organizational skills.

• Demonstrated manual dexterity.

• Attention to detail and demonstrated organizational skills

• Ability to work independently as well as part of a team, to complete assignments within defined time constraints.

• Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices.

• Ability to execute problem solving with support of area lead or management.

• Knowledge of basic electronic systems (email, MS Office, etc.)

• Experience with LIMS and ELN computer applications a plus.

Contacts

• Will work in teams and have continual interaction with members of his/her team as well as other sub-teams within QC, in order to exchange information regarding testing completed, in process and planned.

• Routine contact with supervisor for coaching and general performance management discussions.

• Occasional contact with other line management staff relating to specific project responsibilities may be expected.

Working Conditions

• Specialists primarily work in a cGMP laboratory and follow techniques which require one to be alert, giving a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials.

• Overtime work may be required on weekdays, weekends, holidays, and during adverse weather conditions in support of manufacturing facility.

• Flexibility to work irregular hours and short notice overtime.

Decision Making

• Specialists should be observant of their work area and related tools and identify and report any discrepancy from normal practice or procedure, recommending corrective action.

Supervision Received

• Incumbents normally receive general instructions on routine work and general instructions on new assignments.

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in 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.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

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