Bristol-Myers Squibb is a global BioPharma company firmly focused on its mission to discover, develop and deliver innovative medicines to patients with serious diseases.
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
The Method Transfer and Validation (MTV) team within Analytical Sciences and Technology seeks a dedicated, results-focused Senior Scientist with significant expertise in methods’ validation for late stage/commercial biological products.
The Senior Scientist will interface with the technology enabling teams to ensure current global regulatory requirements, industry standards and sound scientific principles are applied during method validation. The AST group is committed to supporting our global biologics QC network with reliability, integrity, active engagement, and cross functional collaboration.
· Oversee biological method validation projects to define project validation strategies in alignment with global regulatory requirements, industry standards and company validation expectations in collaboration with program stakeholders
· Provide cross-project leadership for action plans to meet objectives and timelines
· Must be capable of independently initiating, directing and overseeing validation activities for multiple projects
· Participate in cross-site and cross-functional meetings to provide expert advice/opinion on method validation approaches
· Will help lead interface with technology teams and QC to solve any validation related issues that arise
· Lead the interface with CR/RS teams to ensure appropriate phase appropriate validation is performed
· Manage scientists responsible for preparing protocols and compiling reports to support method validation.
· Review/Approve documentation (e.g. protocols, reports, master plans, and technical reports) to ensure documentation meets procedural and health authority expectations.
· Proactively identify and escalate risks
· Coordinate activities across the team for optimal efficiency
· Drive continuous improvements and ensure consistent practices
· Respond to health authority responses, as requested
· Support of regulatory filings, including ROW submissions, as requested
· Support for health authority inspections
· Train junior staff on procedures and operations
· MS or PhD degree in Biochemistry, Chemistry, Biology or related field, along with 8 or more years relevant work experience - preferably in the pharmaceutical or biotechnology industries
· Previous experience with biological method validations to support BLA, MAA or other health authority submissions.
· Methods transfer experience is a plus.
· In-depth understanding of ICH and pharmacopeia guidelines for validations
· Demonstrated knowledge of the biological drug development process and regulatory requirements for submissions and basic concepts of Good Manufacturing Practices (cGMP)
· Ability to recognize potential gaps then articulate them to a broad base of Subject Matter Experts.
· Previous inspection experience with regulatory authorities is beneficial
· Proactive approach to problem solving
· Ability to give clear and concise oral and written communications
· Must have an excellent analytical knowledge and strong managerial experience, combined with a strong interpersonal and communication skill set to effectively manage multiple activities in a matrix team environment
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