Job Functions Management of Contract testing laboratories linked to external manufacture Provision of analytical expertise and troubleshooting support in the areas of biologics for the external manufacturing environment linked to contract labs and testing at contract manufacturing sites where relevant Proactively manage all business, budgeting and associated activities linked to contract laboratories in support of external manufacturing Management of Quality activities linked to Contract Testing labs Responsibilities Engage with internal and external stakeholders to plan and manage all testing of biological products at contract testing laboratories and Represent Global External Manufacturing as the Quality Control (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 / Out of Specification (OOS) events at CMOs & CLS providers.
Provide technical support to the Qualified Person (QP) / Responsible Peron (RP) 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, RSCR (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 International Council of Harmonisation (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 Good Manufacturing Practices (GMP) requirements and a working knowledge of Food and Drug Administration (FDA) & European Union (EU) GMP requirements In depth knowledge of Quality Management Systems relating to laboratory operations Ability to objectively critique investigation reports from third parties Ability to manage business plus quality relationship with contract testing labs and support biological testing issues at CMOs Business Acumen linked to managing contract labs, budgeting and associated practices Required Qualification(s) and Desired Experience In-depth knowledge and operational experience at management level in a Pharmaceutical QC laboratory DS 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.
Knowledge of bioassay, peptide and size exclusion chromatographic methods a distinct advantage Management of Third Party relationships (desirable) A minimum of ten (5) years’ experience in a QC / Quality Assurance (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 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.