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The Principal Scientist is part of Validation & Robustness team of MS&T Boudry department. This role is responsible for managing processes related qualification/validation activities through the complete validation life cycle.

Primary responsibilities include:

• Process Performance Qualification,
• Continued Process Verification,
• Continual Improvement Projects.

Serves as a Subject Matter Expert in a specific Process Validation specialty and provides expert technical recommendations / guidance. Leads large scale projects, prepares and leads project schedules / project teams, executes complex validation studies / investigations, and performs associated data analysis applying the principles of statistics and quality risk management.

• Site Lead for the implementation of structures, tools, and processes to actively manage process performance/robustness across the BMS Pharma portfolio.
• Contribute to ensure that new pharma products are launched with an appropriate level of robustness, in collaboration with other MS&T functions and Manufacturing site.
• Design and execute procedures that enable an efficient collection of data ( possibly in real time) from the different unit operations in line with the defined control strategy.
• Perform analysis of data and draw up robustness boards.
• Lead the issuing of Continued Process Verification plans and reports.
• Independently performs and/or leads team in Validation, document generation, management, and task execution.
• Manage projects in the work group and lead specific team initiatives, coordinate the execution of validation projects, prepare project schedules and provide presentations to senior management / stakeholders on project status.
• Manage timelines, resources, and communication for specific Project or initiative.
• Execute validation studies, perform complex data analysis, and write protocol summaries, reports, and technical reports.
• Support other Validation Scientists in the work group and provide technical expertise related to validation approaches and rationales.
• Train and mentor less experienced department personnel.
• Conduct, and assist others, in industry and regulatory research including research into industry standards/FDA guidelines for processes validation and make determinations regarding acceptance criteria and testing.
• Interact and collaborate with departments (on and offsite) as well as vendors, consultants and other external service providers acting as a subject matter expert to provide technical guidance with validation including but not limited to production equipment.
• Design the validation/qualification approach, provide the scientific rationale and acceptance criteria, generate and approve validation/qualification protocols.
• Own department programs and SOPs, and generate revisions as required based on current industry standards and regulatory requirements.
• Lead and execute CAPA plans, risk programs and assessments, investigations, and root cause analysis associated with Qualification/Validation topics.
• Implement changes through standard change control process, assess impact to validated equipment, , and processes.
• Intermediate understanding of site quality Gx P systems supporting document management, change controls, deviations, CAPAs.
• Performs general administrative and organizational activities.
• Complete regulatory, site, and department training requirements on a timely basis.
• Performs other tasks as assigned.

Specific Knowledge, Skills, Abilities:

• Excellent working knowledge of QA, c GMP and the Pharmaceutical Regulatory framework.
• Excellent knowledge of current qualification/validation practices
• The ability to influence and work across organizational boundaries.
• Excellent command of English and preferably another European language
• Strong written and verbal communication and interpersonal skills
• Project and change management experience. Experience with Product Life Cycle Management.
• Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc.).
• Self-starter, team player, effective leader and keen on working in a cross-cultural working environment.

Education/Experience/ Licenses/Certifications:

• Bachelor Degree in Engineering , Chemistry, Pharmacy or Natural Science.
• Minimum 5-7 years of experience in pharmaceutical industry with MSc degree or 8-10 years' experience with BSc and in GMP validation activities are considered an asset but not mandatory.

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.

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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