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Lead Scientist, Analytical Strategy and Governance

2 months ago

Ayer, Massachusetts, United States Bristol-Myers Squibb Full time
About Us
At Bristol Myers Squibb, we redefine the meaning of work. Our environment is not just about tasks; it’s about making a significant impact on patients' lives and advancing your career in a meaningful way. Here, you will engage in diverse and stimulating projects that challenge the status quo, from innovative production processes to groundbreaking therapies. Join a team where your growth is supported through unique opportunities and a culture that values diversity and inclusion.

Company Overview
Bristol Myers Squibb has been a key player in the pharmaceutical industry, with a strong presence in various regions. Our facilities are designed to support the development and manufacturing of life-changing therapies, ensuring that we meet the needs of patients globally.

Position Overview
As a Senior Principal Scientist in Analytical Governance and Scientific Operations, you will report directly to the Director of AGSO. This role is crucial in overseeing the management of all commercial method transfers and validations related to biologics. You will lead project governance across the Biologics Analytical Method & Strategy (BAMS) team, ensuring that analytical changes are effectively managed throughout the network. Your expertise in biologics analytical methodologies and proven leadership in the biopharmaceutical sector will be essential in this position.

Key Responsibilities
  • Collaborate with global quality, product development, and manufacturing sciences to establish governance structures for projects from validation to licensure.
  • Guide and mentor AGSO scientists in executing analytical method validation and technical transfer activities, ensuring adherence to project timelines.
  • Oversee the Biologics Commercial Analytical Governance, including managing the BAMS project portfolio and commercial analytical frameworks.
  • Manage the Global Biologics commercial QC Book of Work, ensuring that testing requirements align with business needs.
  • Facilitate knowledge management processes for BAMS teams, enhancing training and operational efficiency.
  • Implement a quality risk management program to mitigate potential risks in collaboration with manufacturing and quality teams.
  • Lead efforts to identify and implement process improvements, ensuring sustainable operational enhancements.
  • Support audits and inspections, ensuring compliance with laboratory controls and analytical method validations.
  • Exemplify the core values of Bristol Myers Squibb, including Passion, Innovation, and Integrity.
  • Foster a culture of continuous learning and improvement within the team.
Qualifications & Experience
  • Advanced degree in a scientific or pharmaceutical discipline is preferred.
  • In-depth knowledge of Quality Control and Analytical processes, including cGMP regulations.
  • Extensive experience in managing analytical project activities within the biopharmaceutical industry.
  • Strong communication skills, capable of engaging with diverse stakeholders.
  • Proven ability to drive performance and achieve operational objectives.
  • Experience with FDA and international regulatory guidelines.
Why Join Us
  • Contribute to transformative therapies that improve patient outcomes.
  • Be part of a company that values innovation, diversity, and employee development.
  • Enjoy a competitive compensation package with comprehensive benefits.
Commitment to Inclusion
Bristol Myers Squibb is dedicated to fostering an inclusive environment where all employees can thrive. We encourage applications from individuals of all backgrounds and experiences.