Transformative Work at Bristol Myers Squibb
Bristol Myers Squibb is an unconventional workplace where challenging, meaningful, and life-changing work happens every day. Our teams are driven by a passion to transform the lives of patients through innovative medicines.
We offer a wide range of benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. This includes a flexible work environment that supports balance and well-being.
Quality Control Leadership Role
In this role, you will oversee Quality Control (QC) activities related to Drug Product and Incoming Material, ensuring compliance with internal policies, procedures, and regulatory requirements. You will be responsible for providing support for design, execution, troubleshooting, and monitoring of QC processes and testing activities.
Main Responsibilities:
* Lead a team and ensure cGMP compliance of the laboratory area and operations under your responsibility.
* Create a positive and collaborative team environment and ensure that Bristol Myers Squibb standards are met.
* Manage performance and provide technical guidance, coaching, and support to team members.
* Assign training requirements and monitor training status of assigned team members.
* Create team plans to ensure resources are properly allocated and utilized effectively.
* Ensure all equipment used for GMP testing is in a qualified state.
* Audit and approve complex GMP documentation such as laboratory procedures, work practices, plans, protocols, and reports.
* Support Lean Lab initiatives and participate in inspections by Health Authorities.
* Monitor schedule progress and identify risk areas.
* Sustain budget definition and adherence to budget target.
Key Activities:
* Oversee QC incoming material, stability, in-process, bulk product testing activities, and environmental monitoring testing activities.
* Collaborate cross-functionally and interdepartmentally to define testing priorities, assign work to team members, and monitor progress against schedule.
* Ensure timely completion of stability samples in compliant with company procedures.
* Review and approve documentation as required by laboratory procedures.
* Perform final approval and disposition of QC results.
* Provide technical support to QC team members.
* Evaluate compendial compliance of excipients and evaluates any non-compendial supplier test methods against in-house methods and specifications.
* Define incoming testing requirements of Incoming Materials, including specifications.
* Oversight of sampling plan and testing regimes for all Incoming Materials.
* Provides oversight of testing contracted to external laboratories.
Supporting Safe Practices:
* Promote safe practices and behaviors among staff.
* Report incidents to Environmental Health and Safety (EHS) department and participate in investigations.
* Ensure that staff is properly informed on hazards and trained to act in consequence.
* Demonstrate Bristol Myers Squibb values.
Qualifications & Experience:
* BS or advanced degree in Microbiology, Biochemistry, Pharmacy, or relevant scientific discipline or equivalent combination of education, training, and experience.
* Minimum 5 years of work experience in a GMP environment (pharmaceutical industry or similar field).
* 1-3 years of Quality Control Laboratory management experience preferred.
* Exceptional scientific and practical knowledge of analytical techniques (e.g., bio burden, identifications, automatic equipment for testing).
* Working knowledge of relevant US, EU, and global regulations and ICH, ISPE, ASTM standards/guidelines.