Senior Principal Scientist, Manufacturing Technology

Bristol Myers Squibb • Devens, MA

3d

About The Position

The Senior Princip al Scientist is a subject matter expert and process/project owner for biologic drug substance commercial technical transfers, process validations and project portfolio at Bristol Myers Squibb, Devens. The position will serve as lead or critical support for commercial biologics technical transfers and will engage cross-functionally across multiple stakeholder functions. The role will ensure processes are designed and validated per applicable current good manufacturing practices (cGMPs), site procedures, and that processes are defined consistent with regulatory guidance. The role will also be responsible for driving process validation protocols, reports and exceptions (as applicable), and for key sections of Chemistry, Manufacturing, and Controls (CMC) submissions, along with setting relevant standards and procedures. This position will report to the Director, Manufacturing Technology, and will directly support the Process Transfer and Validation group within the Manufacturing Technology organization. The successful candidate will leverage technical ability, stakeholder management and excellent communication ability to deliver Devens site, MS&T and business unit priorities. They will work with site support organizations (Manufacturing, Supply Chain, Digital Plant, Site Engineering, and Quality Assurance) to remove obstacles and ensure timely results. The role may require direct manufacturing support during campaign execution.

Requirements

• Bachelor’s degree or equivalent in relevant engineering or scientific discipline with extensive relevant experience. A minimum of 8 years is required. A combination of education and experience may be acceptable.
• Technical execution experience in technology transfer and Process Performance Qualification.
• Understanding and knowledge of global regulatory requirements related to the design and control of biologics drug substance processes.
• Thorough knowledge of quality systems, Quality by Design, validation princip les for product and manufacturing processes, and process control fundamentals in commercial manufacturing.
• Excellent communication and presentation skills and vast experience interfacing with multiple stakeholders and partner functions
• Ability to work in a fast paced, complex and changing environment.
• Excellent analytical, technical, and strategic thinking skills and experiences.
• Strong understanding of project management systems and tools is preferred.
• Excellent organizational skills and the ability to successfully manage a multitude of technical projects.

Nice To Haves

• Previous direct support of CMC filing activities is preferred.
• Strong understanding of project management systems and tools is preferred.

Responsibilities

• Responsible for the leadership and execution of biologics drug substance projects including commercial technology transfer, technical oversight of process design, process validation/re-validation, regulatory package authoring and successful inspection and approval for the Devens Biologics site.
• Leads complex technical transfers to support BMS business objectives. Specifically, serves as a functional technical transfer lead and/or a workstream lead (as required) supporting the Devens site.
• Influences technical direction for biologics drug substance manufacturing across media/buffer, cell banking, cell culture, purification, formulation and fill through to freeze.
• Thorough knowledge of quality systems, Quality by Design, validation princip les for product and manufacturing processes, and process control fundamentals in technical transfer and post approval process changes.
• Lead complex technical projects within biologics drug substance manufacturing and drives decisions that require developing new options to solve highly complex and/or novel problems.
• Responsible for supporting technical aspects of site regulatory inspections with thorough understanding of regulatory environment and industry trends for biologics drug substance specifically in relation to Pre-Approval Inspections (PAI) supporting technical transfer and post approval process changes.
• Is responsible for the timely delivery of assigned projects across technical transfer, process validation/qualification, and post approval process changes at Devens Biologics.
• Routinely interacts within the MS&T internal BMS network for technical and operational improvements and issue resolution.
• Drives effective working relationships with other functional organizations, such as Quality, Operations, Engineering, Global Regulatory Science, Technical Product Teams and others, both internally and externally to the site.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior