Principal Scientist, Validation & Robustness
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The Principal Scientist is part of the “Validation & Robustness” team of MS&T Boudry department. This role is responsible for managing processes related to 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.
Key Responsibilities:
* 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 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.
* 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 GxP 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, cGMP 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 in GMP validation activities are considered an asset but not mandatory.
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