ExM Q Analytical Manager

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Company Background

BMS has one of the most reliable supply networks and our clinical operations program is among the best and busiest anywhere. We are a company that is forward thinking, a company in which diversity and inclusion are at the forefront of how we view our talent and how we work. Our science is second to none and the transformation work underway will enable us to continue to lead our peer group.

Bristol-Myers Squibb External Manufacturing is looking to recruit a temporary ExM Q Analytical Manager.

Job Function

• Management of analytical tech transfer activities across API & Drug Product in an external manufacturing environment
• Provision of analytical expertise and troubleshooting support in the areas of API’s and intermediates, drug products, raw materials, and Pharmacopoeia requirements in an external manufacturing environment
• Proactively manage all API & Drug Product Contract Laboratory Service (CLS) providers to Global External Manufacturing from a quality and compliance oversight perspective.

Responsibilities

• Engage with internal and external stakeholders to plan and manage the program for analytical method transfers from BMS to CMOs or CMO to CMO.
• Represent Global External Manufacturing as the QC laboratory subject matter expert in support of due diligence audits and for cause audits where laboratory related issues are a focus for such audits
• Review and approve all major laboratory investigations/OOS events at CMOs & CLS providers.
• Provide technical support to the QP and Quality Operations Managers in relation to same.
• Review and approve analytical change control documents associated with CMOs & CLS providers
• Facilitate and manage the communication flow to and from CMO analytical functions and global functions across BMS such as Global Testing Standards, HQ
• Reference Standards Management Team, Global Analytical Services, Global Regulatory Sciences etc.
• Review and approve analytical method validation documentation & activities at CMOs and CLS providers to determine compliance with ICH requirements and manage remediation of gap analysis at BMS or CLS
• Provide analytical expert support for regulatory submissions
• Prepare, approve and maintain the Quality Agreement with each CLS provider.
• Establish and monitor an effective metrics program to measure the performance of the CLS providers.
• Provide training to wider External Manufacturing team

Required Competencies

• Ability to work independently and within team matrix environments
• Thorough knowledge of worldwide regulatory GMP requirements and a working knowledge of FDA & EU GMP requirements
• In depth knowledge of Quality Management Systems relating to laboratory operations
• Ability to objectively critique investigation reports from third parties
• Good knowledge of API and Drug Product processes and ability to differentiate between requirements

Required Qualifications and Desired Experience

• In depth knowledge and operational experience at management level in a Pharmaceutical QC laboratory
• API and Drug Product experience
• Strong knowledge of analytical technical transfer processes, compliance requirements and proven troubleshooting skills
• Project Management skills are required
• Strong technical knowledge of modern chromatographic methodologies. 
• Management of Third Party relationships (desirable)
• A minimum of 5 years experience in a QC/QA environment is required for this role.
• A minimum of a BSc in Chemistry or related discipline is also required together with a sound understanding of GMP & ICH guidelines.

The qualified candidate demonstrates characteristics of our BMS BioPharma Behaviors. For more details refer to InSite BMS Website/ People and Performance/BMS BioPharma Behaviors.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

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