Principal Scientist, RNA Purification Process Development
Responsibilities
- Lead RNA purification development strategy for drug substance programs (circular RNA and mRNA) across early- to late-stage development.
- Provide strategic oversight of process development and manufacturability; contribute hands-on input to resolve technical challenges.
- Use first-principles risk assessment to define mitigation strategies and make scientific recommendations at key milestones.
- Represent drug substance strategies in cross-functional CMC teams (analytical development, engineering, regulatory affairs, supply chain).
- Set priorities/objectives for Purification PD; mentor/develop purification scientists; foster an inclusive, high-performance team.
- Propose departmental initiatives to improve scientific workflows, sustainability, and operational efficiency.
- Build external partnerships; represent capabilities via internal reviews, scientific conferences, and peer-reviewed publications.
- Serve as a scientific voice across CMC and enterprise forums; partner with research, analytical development, engineering, and drug product development.
Qualifications
- MS in Bio/Chemical Engineering, Bio/Chemistry, or related field with 8+ years, or PhD with 3+ years in science-related disciplines.
- Expertise in chromatography, filtration, and separation unit operations.
- Working knowledge of DoE and multivariate data analysis.
- Experience with RNA analytics/biophysical characterization (HPLC, CE, NGS, gel electrophoresis).
- Knowledge of cGMP, ICH, regulatory guidelines, and QbD/risk management.
- Technical support experience for clinical manufacturing (investigations, continuous improvement).
- In vitro transcription knowledge preferred.
- Exceptional written/oral communication; ability to lead complex projects and influence matrix teams.
Benefits/Compensation (explicit)
- Cambridge, MA: $153,660β$186,203 (plus possible incentive cash/stock).
- Health coverage, wellbeing support, 401(k), disability/life insurance, and additional work-life benefits (e.g., PTO/flexible time off and Global Shutdown, eligibility-dependent).
Application instruction
- If the role doesnβt perfectly match your resume, encouraged to apply anyway.