Principal Scientist, MS&T

Bristol Myers Squibb • Manatí, PR

16h • $106,520 - $129,080

About The Position

The Principal Scientist, MS&T is accountable for transferring, managing, optimizing, and supporting manufacturing processes across the Manatí site. The role ensures timely introduction, robust processes, and quality products transferred from Research and Development, other BMS sites, or business partners, in support of established timing targets and business plans. The incumbent serves as the principal subject matter expert and process owner for end-to-end manufacturing of liquid and lyophilized parenteral products at Manatí.

The role ensures processes are designed and validated in accordance with applicable cGMPs and site procedures, and that process definitions are consistent with regulatory filings. It must comply with security guidelines, Environmental Health and Safety regulations, and current Good Manufacturing Practices. The position works with a high degree of independence, provides technical leadership, and makes decisions and recommendations affecting technology transfers, manufacturing processes, resources, and time to market.

The position is based in Manatí, Puerto Rico. The posted compensation range is $106,520–$129,080. Full-time employees may also be eligible for discretionary cash incentives and stock opportunities, and benefits subject to applicable plan terms and eligibility.

Requirements

• Bachelor’s degree in Pharmacy, Engineering, Chemistry, or Science and 9–12 years of directly related Technical Services experience in the pharmaceutical industry; alternatively, a Master’s degree and 6–9 years of experience, or a PhD and 4–6 years of experience.
• Excellent organizational skills and ability to manage multiple technical projects.
• Aptitude in engineering principles.
• Ability to lead cross-functional site teams in executing technical transfer activities.
• Ability to work in a fast-paced, complex, and changing environment.
• Ability to manage personnel and financial resources.
• Strong knowledge and practical experience in manufacturing processes, technologies, processing equipment, cGMPs, and FDA regulations and trends.
• Strong project management skills and experience.
• Excellent analytical and strategic thinking skills and experience.
• Demonstrated leadership, interpersonal, and teamwork skills; strong mentoring and people-development skills and track record.
• Outstanding oral and written communication skills in English and Spanish.
• Subject matter expertise in industrial parenteral formulation and filling processes.
• Ability to work with maximum independence and minimum supervision from MS&T leadership.
• Must comply with security guidelines, Environmental Health and Safety regulations, and current Good Manufacturing Practices.

Nice To Haves

• Three years of experience in parenteral manufacturing of protein therapeutics (biologics), with demonstrated knowledge of how these products behave in parenteral processes.

Responsibilities

• Serve as subject matter expert in liquid, lyophilized, and syringe parenteral processes and formulation, maintaining knowledge of industry best practices.
• Support Manatí technical transfer projects, including developing project plans and forming teams and charters for new product transfers.
• Develop and execute technology transfer plans for new products, integrating site timelines and event schedules with corporate priorities.
• Act as a core team member on new product introduction teams for internal R&D, contract-manufactured, and alliance products.
• Partner with Innovation Technologies, Information Management, Engineering Maintenance, and Manufacturing to ensure equipment and automation can deliver transferred manufacturing processes.
• Integrate plans and resources to achieve timely process support, productivity, technology transfer, and validation activities across the product portfolio.
• Perform Design of Experiments and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies.
• Partner with site management to identify industry best practices in technology transfer and pharmaceutical technology.
• Develop and maintain working relationships with division groups in support of technology transfer, validation, productivity, and process support activities.
• Lead, motivate, mentor, and provide technical leadership to junior scientists; develop team members to meet plant and company goals.
• Serve as communication liaison for transfer, validation, optimization, and daily support activities for the assigned product portfolio.
• Serve as site liaison and primary author for process sections of CMC submissions.
• Represent the site and lead site Technology Transfer Teams as needed to ensure timely delivery of targets.
• Author or approve validation and experimental protocols as needed.
• Make decisions concerning technology transfers, pharmaceutical technology practices, process changes, manufacturing-event support, technology development, and department resources.
• Make decisions regarding implementation and revision of policies and procedures in compliance with BMS, federal, and local requirements.
• Create ideas and processes, drive continuous innovation, prioritize projects and schedules, and formulate recommendations for programs that may require significant resources.
• Execute assigned activities under established Puerto Rico regional and corporate guidelines.

Benefits

• Potential eligibility for discretionary incentive cash and stock opportunities.
• Wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan terms and eligibility.
• Puerto Rico employees receive 160 hours of paid vacation annually for new hires, subject to manager approval; 11 paid company holidays; and 3 optional holidays.
• Depending on eligibility, additional time-off benefits may include paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year’s Day.

What This Job Offers

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