Principal Scientist, LNP Process Development & MS&T
Bristol Myers Squibb
June 26, 2026
Remote friendly (Cambridge, MA)
United States
Operations
Position Summary
The Principal Scientist provides scientific leadership for bulk drug product programs (preclinical to early-stage) and leads tech transfer and implementation of process into clinical production in a GMP environment.
Key Responsibilities
- Lead tech transfer from nonclinical production/development to clinical production site; interface with site leadership.
- Provide strategic oversight of process development and manufacturability; resolve critical technical challenges.
- Use high-throughput data approaches to assess/mitigate risks and make recommendations at program milestones.
- Represent bulk drug product strategy in cross-functional CMC teams (research, analytical, engineering, regulatory, supply chain).
- Set priorities/objectives for LNP PD MSAT; align with portfolio goals.
- Mentor and develop scientists; foster psychological safety, accountability, and collaboration.
- Propose initiatives to improve workflows, sustainability, and efficiency.
- Build external academic/industry collaborations; represent capabilities via internal reviews/conferences/publications.
- Serve as key scientific voice in cross-functional CMC and enterprise forums.
Qualifications & Experience (Required/Preferred)
- MS in Bio/Chemical Engineering/Bio/Chemistry or related with 8+ years, or PhD with 3+ years.
- Expertise: lipid nanoparticle formation, conjugation reactions, tangential flow filtration.
- DoE and multivariate data analysis.
- Process analytics and biophysical characterization (e.g., DLS, encapsulation efficiency).
- Experience with internal/external clinical manufacturing sites.
- Knowledge of cGMP, ICH, regulatory guidelines, and QbD for risk management.
- Strong written/oral communication; lead independently; influence matrixed/governance decisions.
- Industrial experience managing/mentoring scientists; GMP background; change controls, clinical strategy, deviation resolution with Quality.
- Plus: advanced math/nucleic acid & lipid chemistry/biology; scale-down & mechanistic models; international travel.
Compensation & Benefits
- Cambridge, MA: $153,660–$186,203.
- Benefits include: medical/pharmacy/dental/vision; wellbeing support; 401(k), disability, life insurance, and other protections.
- Paid Time Off (varies by employee type/location; includes flexible/unlimited PTO for some US exempt roles and annual vacation plus holidays for others).
Application Instructions
- Apply for the role (Req. R1603856).
The Principal Scientist provides scientific leadership for bulk drug product programs (preclinical to early-stage) and leads tech transfer and implementation of process into clinical production in a GMP environment.
Key Responsibilities
- Lead tech transfer from nonclinical production/development to clinical production site; interface with site leadership.
- Provide strategic oversight of process development and manufacturability; resolve critical technical challenges.
- Use high-throughput data approaches to assess/mitigate risks and make recommendations at program milestones.
- Represent bulk drug product strategy in cross-functional CMC teams (research, analytical, engineering, regulatory, supply chain).
- Set priorities/objectives for LNP PD MSAT; align with portfolio goals.
- Mentor and develop scientists; foster psychological safety, accountability, and collaboration.
- Propose initiatives to improve workflows, sustainability, and efficiency.
- Build external academic/industry collaborations; represent capabilities via internal reviews/conferences/publications.
- Serve as key scientific voice in cross-functional CMC and enterprise forums.
Qualifications & Experience (Required/Preferred)
- MS in Bio/Chemical Engineering/Bio/Chemistry or related with 8+ years, or PhD with 3+ years.
- Expertise: lipid nanoparticle formation, conjugation reactions, tangential flow filtration.
- DoE and multivariate data analysis.
- Process analytics and biophysical characterization (e.g., DLS, encapsulation efficiency).
- Experience with internal/external clinical manufacturing sites.
- Knowledge of cGMP, ICH, regulatory guidelines, and QbD for risk management.
- Strong written/oral communication; lead independently; influence matrixed/governance decisions.
- Industrial experience managing/mentoring scientists; GMP background; change controls, clinical strategy, deviation resolution with Quality.
- Plus: advanced math/nucleic acid & lipid chemistry/biology; scale-down & mechanistic models; international travel.
Compensation & Benefits
- Cambridge, MA: $153,660–$186,203.
- Benefits include: medical/pharmacy/dental/vision; wellbeing support; 401(k), disability, life insurance, and other protections.
- Paid Time Off (varies by employee type/location; includes flexible/unlimited PTO for some US exempt roles and annual vacation plus holidays for others).
Application Instructions
- Apply for the role (Req. R1603856).