Job Information
Bristol Myers Squibb ExM Quality Analytical Manager in Boudry, Switzerland
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.
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. Read more: careers.bms.com/working-with-us .
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
Support internal and external audits as Quality Control (QC) laboratory subject matter expert
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)
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 an inclusive culture, promoting diversity 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 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 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.
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 adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1582761
Updated: 2024-07-02 03:00:09.151 UTC
Location: Boudry-CH
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.