Principal Scientist, LNP Process Development & MS&T
Listed on 2026-06-30
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Research/Development
Biotech Research, Regulatory Compliance Specialist, Research Scientist, Pharmaceutical Science/ Research
Position Summary
The Principal Scientist, LNP Process Development & MS&T provides scientific leadership for bulk drug product programs spanning preclinical to early-stage development and leads the tech transfer and implementation of processes into clinical production. This role is principally focused on hands‑on scientific contribution, driving robust experimental execution and linking small‑scale development to GMP‑scaled manufacturing.
Key Responsibilities- Scientific Leadership
Lead tech transfer from nonclinical production to clinical sites, interface with site leadership to ensure production success, and provide strategic oversight of process development and manufacturability while resolving critical technical challenges. - Apply high‑throughput data‑driven 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.
- People Leadership & Talent Development
Set clear priorities and objectives for LNP PD MSAT, mentor and develop scientists, and foster an inclusive, high‑performance team environment built on psychological safety, accountability, and collaboration. - Innovation & Organizational Contribution
Propose and lead departmental initiatives that improve scientific workflows, sustainability practices, and operational efficiency; build and maintain relationships with external academic and industry partners; represent capabilities at internal reviews, scientific conferences, and peer‑reviewed publications. - Cross‑Functional Collaboration
Serve as a key scientific voice in cross‑functional CMC teams and broader enterprise forums, partner with research, analytical development, engineering, and drug substance development, and collaborate with leadership to drive strategic alignment across the portfolio.
- Degree in Bio/Chemical Engineering, Bio/Chemistry, or related field; MS with 8+ years’ experience or PhD with 3+ years’ experience in a related scientific discipline.
- Expertise with lipid nanoparticle formation, conjugation reactions, and tangential flow filtration unit operations.
- Working knowledge of statistical design of experiments (DoE) and multivariate data analysis.
- Experience 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; 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, supporting change controls, developing clinical strategies, and resolving deviations with Quality teams.
- 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.
Cambridge – MA – US: $153,660 – $186,203 (starting compensation range for a full‑time employee). Additional incentive cash and stock opportunities may be available based on eligibility. Final compensation is determined by demonstrated experience.
Benefits- Health Coverage:
Medical, pharmacy, dental, and vision care. - Well‑being Support: BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs.
- 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.
- Paid Time Off:
Flexible time off (unlimited, with manager approval) for US exempt employees; location‑specific vacation and holiday schedules otherwise. - Additional time off:
Unlimited paid sick time, optional volunteer days, summer hours flexibility, leaves of absence, and a global shutdown between Christmas and New Year’s Day, where applicable.
BMS will consider qualified applicants with arrest and conviction records in accordance with applicable laws. BMS is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable accommodations, and ongoing support.
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