Principal Research Scientist I

Responsibilities

Accountable for driving CMC development plans in collaboration with technical functions and in alignment with overall program objectives.

Ensures technical rigor and is accountable for team performance and technical deliverables of the project.

Leads technical issue resolution and implements robust solutions that are aligned cross-functionally.

Schedules technical team meetings, develops agendas, issues program highlights, and drives project timelines to ensure successful process development and regulatory submission.

Works with the functional area leads to assemble content for technical reviews.

Apprises CMC and PDS&T management of plans and risks through regular communications and periodic reviews throughout development.

Responsible for the preparation and review of regulatory filings. Responds to urgent regulatory queries.

Serves as spokesperson for the drug substance CMC project team on cross-functional product teams and ensures information flow among line functions.

Requirements

Bachelor’s degree with at least 14 years of relevant experience; Master’s Degree with at least 12 years of relevant experience; or PhD with at least 6 years of relevant experience.

Demonstrated knowledge of regulatory requirements and strong technical knowledge of biologics process and analytical development from early development through commercialization including process characterization studies, process scale-up, and technology transfer.

Must demonstrate excellent scientific writing and verbal communication skills, including experience authoring technical and regulatory documentation.

Prior experience must include leadership in technical roles and demonstrated ability of problem solving on difficult technical problems.

Prior experience working in highly matrixed teams and demonstrated leadership skills to influence and guide teams in achieving CMC deliverables while balancing scientific, quality, and compliance requirements.

Strong project management skills with ability to manage multiple programs.

Qualifications

Bachelor's degree with at least 14 years of relevant experience; Master's Degree with at least 12 years of relevant experience; or PhD with at least 6 years of relevant experience.

Demonstrated knowledge of regulatory requirements and strong technical knowledge of biologics process and analytical development from early development through commercialization including process characterization studies, process scale-up, and technology transfer.

Must demonstrate excellent scientific writing and verbal communication skills, including experience authoring technical and regulatory documentation.

Prior experience must include leadership in technical roles and demonstrated ability of problem solving on difficult technical problems.

Prior experience working in highly matrixed teams and demonstrated leadership skills to influence and guide teams in achieving CMC deliverables while balancing scientific, quality, and compliance requirements.

Strong project management skills with ability to manage multiple programs.

Skills

Excellent scientific writing and verbal communication skills, including experience authoring technical and regulatory documentation.

Demonstrated ability of problem solving on difficult technical problems.

Leadership in technical roles.

Strong project management skills.

Benefits

Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k).

Pay

$124,500 - $236,500 USD

Schedule

Full-time