Exm Quality Analytical Manager
vor 7 Monaten
**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
This role is for 24 months to support the analytical testing aspects associated with Drug Substance and Drug Product manufacturing, working in an external manufacturing environment (with CMO's) within Virtual Plant Teams (VPT's). The ExM Quality Analytical Manager will provide analytical support to the VPT's and CMO Technical Transfer Projects.
**Major Duties and Responsibilities**:
- Provision of analytical expertise and troubleshooting support in the areas of biologics for the external manufacturing(ExM) environment
- Support analytical aspects of technical transfers to CMO's
- Engage with internal and external stakeholders to plan and manage all testing of biological products at contract manufacturing organisations (CMO's) and contract test laboratories (CTL's)
- Review and approve all laboratory investigations/deviations/Out of Specification (OOS) events at CMO's and CTL's with support from method SME's, as required
- Act as Lead Investigator on BMS infinity record as required for major analytical related deviations
- Review and approve analytical change controls from CMO's and CTL's and act as impact assessor on BMS change controls linked to CMO and CTL testing
- Raise BMS change controls related to analytical changes at CMO's and CTL's as required
- Manage the communication flow to and from CMO/CTL analytical functions and global functions across BMS such as Global Testing Standards, RSCR - Reference Standards Management Team, Global Quality Analytical Science & Technology, Microbiology Centre of Excellence etc.
- Ensure supply of reference standards and critical reagents needed for testing at CMO's and CTL's
- Liaison with Global Stability team for CMO stability program
- Complete sample submission forms for testing at CTL's and monitor sample shipments, samples receipt, testing and release status at CTL's
- Ensure review and approval of analytical method validation/transfer/verification documentation & activities at CMOs and CTLs to determine compliance with International Council of Harmonisation (ICH) requirements and manage remediation of gap analysis at BMS or CMO/CTL
- Support the generation and review of sample plans, APQR's, Risk Assessments, Quality Agreements etc.
- Support analytical aspects of regulatory submissions, as required
- Support Procurement in Request for proposal (RFP) process
**Education**:
Minimum B.A. or B.Sc. in life sciences
**Experience/Knowledge**:
- 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 ensure objective critique of analytical investigation reports from CMOs or CTLs
- Ability to manage business plus quality relationship with contract testing labs and support biological testing issues at CMOs
- Previous experience in QC laboratory is highly desirable
- Previous experience using electronic document and deviation management systems is desirable
- Working knowledge of analytical technical transfers is desirable
**Skills/Competencies**:
- In-depth knowledge and operational experience at management level in a Pharmaceutical QC laboratory
- Drug Substance 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)
**Uniquely Interesting Work, Life-changing Careers**
**On-site Protocol**
BMS has a diverse 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 con
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