Principal Scientist, LNP Process Development & MS&T

Bristol Myers SquibbCambridge, MA
$153,660 - $186,203Onsite

About The Position

The Principal Scientist, LNP Process Development & MS&T plays a central role in enabling the success of batches in clinical development across multiple products. Connecting with both the larger LNP PD team and with research to develop clinical scale batches that are representative across scales and sites. The Principal Scientist is a scientific leader responsible for driving clinical manufacturing strategy, influencing cross-functional decisions, and delivering high-impact outcomes across an increasingly diverse portfolio. The Principal Scientist provides scientific leadership for bulk drug product programs spanning preclinical to early-stage development and leading the tech transfer and implementation of process into clinical production. This role is primarily focused on hands-on scientific contribution by driving sound experimental execution and establishing the linkage from small scale process to manufacturing implementation at scale in a GMP environment.

Requirements

  • MS with 8+ years’ or PhD with 3+ years’ experience in science related disciplines
  • Expertise with lipid nanoparticle formation, conjugation reactions, and tangential flow filtration unit operations
  • Working knowledge of statistical design of experiments (DoE) and analysis of multivariate data
  • Experience with performing and interpreting process analytics and biophysical characterization techniques such as DLS and Encapsulation Efficiency
  • Experience working with both internal and external clinical manufacturing sites
  • Knowledge of cGMP, ICH, regulatory guidelines and QbD principles as they apply to risk management and clinical manufacturing
  • Exceptional written and oral communication skills, with the ability to convey complex scientific concepts clearly to both technical and non-technical audiences
  • Ability to lead complex projects independently and influence decisions across matrixed teams and governance forums.
  • Prior experience managing, mentoring, or developing scientists in an industrial setting
  • Demonstrated background working in a GMP environment and supporting change controls, developing clinical strategies, and resolving deviations in conjunction with Quality teams

Nice To Haves

  • Knowledge of advanced mathematics, nucleic acid chemistry, lipid chemistry, and biology is a plus
  • Knowledge of establishing and qualifying scale down models and mechanistic models for process characterization is a plus
  • May require international travel

Responsibilities

  • Lead the tech transfer from nonclinical production and development to a clinical production site, interfacing with site leadership to ensure clinical production success.
  • Provide strategic oversight of process development and manufacturability, while contributing hands-on scientific input where needed to resolve critical technical challenges.
  • Apply high throughput data drive approaches to assess and mitigate risks, defining mitigation strategies and making critical scientific recommendations at key program milestones
  • Represent bulk drug product development strategies in cross-functional CMC teams, ensuring alignment across research, analytical development, engineering, regulatory affairs, and supply chain
  • Set clear priorities and objectives for LNP PD MSAT in alignment with portfolio goals and LNP PD’s broader organizational strategy
  • Mentor and develop scientists across LNP PD MSAT, contributing to a culture of scientific excellence and continuous learning
  • Foster an inclusive, high-performance team environment built on psychological safety, accountability, and collaboration
  • Propose and lead departmental initiatives that improve scientific workflows, sustainability practices, and operational efficiency
  • Build and maintain collaborative relationships with external academic institutions and industry partners to accelerate scientific advancement
  • Represent capabilities at internal reviews, scientific conferences, and through peer-reviewed publications
  • Serve as a key scientific voice in cross-functional CMC teams and broader enterprise forums
  • Partner with functional areas - including research, analytical development, engineering, and drug substance development
  • Collaborate with organization leadership to drive strategic alignment across the portfolio

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.
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