Position: Principal Scientist, Manufacturing Technology
Location: Devens, MA
Position Summary The Principal 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.
Key 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 principles 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.
Qualifications & Experience - Bachelor's degree in a relevant engineering or scientific discipline and 9-12 years of relevant experience, or a Master's degree and 6-9 years of relevant experience, or a PhD and 4-6 years of relevant experience. A combination of education and experience may be considered where appropriate.
- Technical execution experience in technology transfer and Process Performance Qualification. Previous direct support of CMC filing activities is preferred. 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 principles 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.
Compensation Overview:Devens - MA - US: $139,230 - $168,714
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
- 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.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
On-site ProtocolBMS has an 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.
