Manager, QA Laboratory Operations

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BMS Cruiserath Biologics is seeking to recruit a Manager, QA Laboratory Operations for Sterile Drug Product.

Reporting to the Senior Manager, QA Laboratory Operations, the Manager will support the start-up of a commercial drug product manufacturing facility for its biologic’s commercial portfolio and clinical pipeline and be the primary delegate for the Senior Manager.  During start-up, this role will work in conjunction with the project team to provide QA oversight and support to QC start up activities, GMP operational readiness, Method Transfer and Laboratory Equipment Qualification activities.

Post start-up the successful candidate will be part of the QA Laboratory Operations team supporting routine commercial sterile drug product testing and release activities.

The start-up nature of this project will require adaptability & innovation due to the multiple project phases and multiple products onsite. The role will be both challenging & rewarding and will thus ensure that the successful candidate can seize a wide range of development opportunities within BMS. The Sterile Drug Product project scope includes construction and commissioning of new SDP product suite with parts prep, formulation, aseptic filling and capping of liquid & freeze-dried vials, aseptic filling of syringes, and Visual Inspection capabilities. The project also includes new and expanded clean utilities.

Key Responsibilities During Start Up

• Provide QA oversight and support to start up activities, GMP operational readiness, Method Transfer and Equipment Qualification
• Support qualification activities including QA approval of SOPs, deviations, CAPAs, change controls, risk assessments, equipment qualification documentation and method transfer documentation for QC operations.
• Responsible for coaching and development of staff and direct personnel to achieve operational goals and ensure the timely completion of tasks.
• Partnership with CQV and QC team in delivering the GMP scope of work associated with the startup of sterile drug product operations at Cruiserath.
• Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

Key Responsibilities During Commercial Operations

• QA Laboratory Operations oversight of product testing and release activities for commercial and clinical sterile drug product
• Laboratory Investigation system owner for the QC laboratories and Contract Test laboratories
  • Manage the QC Triage business process
  • Laboratory Investigations SME during regulatory agency inspections
  • QA Laboratory Operations Lead at Investigations Review Board (IRB)
  • Liaising with manufacturing site and/or contract laboratory for complex investigations
  • QA Approver for complex/multi-functional deviations, root cause investigations, QC Laboratory investigations, impact assessments and associated CAPAs
• QA Support
  • Operational SOPs, test methods, forms and directives
  • Annual Product Reviews (APQRs)
  • Annual Trend reports
  • Laboratory equipment/instrument qualification protocols and reports
  • Method validations / technical transfers protocols and reports
• Responsible for coaching and development of staff and direct personnel to achieve operational goals and ensure the timely completion of tasks.
• Drive and support culture of continuous improvement initiatives and safe working practices.
• Support Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.
• Support the execution of the Self Inspection programme
• Designee for Senior Manager, QA Laboratory Operations, when required
• Supporting the hiring, development and coaching of key members of the QA Laboratory Operations team

Qualifications & Experience

The successful candidate must possess:

• Bachelor/Masters in Science, or related discipline with a minimum of 5 years’ experience within the Biopharmaceutical/Pharmaceutical industry
• Detailed knowledge of Sterile Drug Product would be a distinct advantage.
• Demonstrated knowledge of applicable EU, FDA and other regulatory requirements including the principles of Annex 1 and how they translate into a contamination control strategy for sterile manufacture.
• A strong technical aptitude, global regulatory experience and demonstrated experience interfacing with regulators
• A thorough understanding of cGMP requirements for laboratory compliance including equipment, instrumentation and method qualification requirements
• Demonstrated in-depth knowledge of deviation and change management processes
• Required to work on his/her own initiative in addition to working as part of a team. Must be able to work across a team matrix to meet accelerated timelines.
• Capable of positively influencing others to bring resolution to complex issues
• Excellent communication and presentation skills
• Excellent trouble shooting and problem solving skills as well as an ability to coach and mentor individuals or teams through complex problems
• Excellent time management and organizational skills along with a proven ability to multi-task
• Employees are expected to display the BMS Biopharma Behaviours, which enable them to be successful and perform at their highest level.

Why you should apply

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym

#LI-Onsite

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 a supportive culture, promoting global participation 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

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

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 [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

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/

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