Principal Scientist, Manufacturing Technology (Process Transfer, Validation and Projects)

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Position: Principal Scientist, Manufacturing Technology (Process Transfer, Validation and Projects)

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 Associate Director, Process Transfer and Validation. 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.

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.
• 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 or equivalent in relevant engineering or scientific discipline with extensive relevant experience. A minimum of 6 years is required. A combination of education and experience may be acceptable.

• 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.

The starting compensation for this job is a range from US-MA- 149,640-$181,300 plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.

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 then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS 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.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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