CMC Program Associate - Hybrid (Waltham)

Oruka Therapeutics; Waltham (MA); Hybride; USD 104 000 - 146 000; Plein temps

Avantages offerts par ce poste

Equity

Performance bonus

Hybrid work arrangement

Career development opportunities

Inclusive team environment

Résumé du poste

Oruka Therapeutics in Waltham, MA is seeking an Associate or Sr. Associate to join the CMC Project Management and Operations team.

This hybrid role supports late-stage manufacturing, documentation workflows, and cross-functional coordination to advance clinical-stage programs. The ideal candidate has a life sciences degree with 0–4 years of relevant experience, strong writing and organization skills, and comfort with GMP concepts.

Qualifications

• Master’s degree with 0–2 years experience, or Bachelor’s with 2–4 years.
• Experience in biopharmaceutical or regulated drug development environment.
• Strong organizational and communication skills; ability to manage multiple priorities.

Responsabilités

• Support CMC program execution with day-to-day coordination of late-stage manufacturing and regulatory readiness activities.
• Maintain CMC documentation workflows, version control, and archival of key program documents.
• Track CMC deliverables, timelines, and risks across workstreams; escalate issues as needed.
• Prepare meeting materials, minutes, dashboards, and action trackers for governance reviews.
• Coordinate with external partners and CDMOs; manage document exchanges and status updates.

Connaissances

Project coordination

Documentation management

Cross-functional collaboration

Written & verbal communication

MS Office / SharePoint / Smartsheet

Formation

Master’s degree in life sciences / engineering / pharma sciences / biotech

Bachelor’s degree in related field

Outils

Microsoft Office

SharePoint

Smartsheet

Description du poste

Oruka Therapeutics in Waltham, MA is seeking an Associate or Sr. Associate to join the CMC Project Management and Operations team.

This hybrid role supports late-stage manufacturing, documentation workflows, and cross-functional coordination to advance clinical-stage programs. The ideal candidate has a life sciences degree with 0–4 years of relevant experience, strong writing and organization skills, and comfort with GMP concepts.