Principal Research Scientist I

As the mAb lead for clinical programs, responsible for supporting regulatory approval of biologics drug substances by leading technical teams throughout Phase 1, Phase 2, and Phase 3 development and authoring Chemistry, Manufacturing, and Controls (CMC) filing content.

Responsibilities:
- Drive CMC development plans with technical functions in alignment with program objectives.
- Ensure technical rigor; accountable for team performance and technical deliverables.
- Lead technical issue resolution; implement robust, cross-functionally aligned solutions.
- Ensure phase-appropriate control strategy based on timelines and project risks.
- Schedule technical team meetings; develop agendas; drive project timelines for process development and regulatory submission.
- Work with functional area leads to assemble content for technical reviews.
- Communicate and review plans/risks with CMC and PDS&T management throughout development.
- Prepare and review regulatory filings; respond to urgent regulatory queries.
- Serve as spokesperson for the drug substance CMC project team and ensure information flow.
- Manage projects using a matrix management approach.

Qualifications:
- Bachelor’s +14 years; Master’s +12 years; or PhD +6 years relevant experience.
- Knowledge of regulatory requirements and biologics process/analytical development (process characterization, scale-up, technology transfer).
- Excellent scientific writing and verbal communication; experience authoring technical/regulatory documentation.
- Leadership in technical roles; ability to solve difficult technical problems.
- Experience in highly matrixed teams; ability to influence teams to achieve CMC deliverables while balancing scientific, quality, and compliance requirements.
- Strong project management skills; ability to manage multiple programs.

Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible to participate in long-term incentive programs.