Associate/Sr. Associate - CMC Project Management & Operations

Oruka Therapeutics•Waltham, MA

1d•Hybrid

About The Position

Oruka Therapeutics is developing novel biologics for chronic skin diseases, aiming to provide patients with significant freedom from their conditions through infrequent dosing. The company is advancing a proprietary portfolio of antibodies targeting the core mechanisms of plaque psoriasis and other dermatologic and inflammatory diseases. Oruka is seeking talented individuals passionate about making a difference and contributing to an engaged, inclusive, and positive company culture. This role is pivotal in developing and managing systems for critical CMC projects to drive the success of clinical-stage programs. The ideal candidate will possess strong communication skills, enjoy cross-functional collaboration, be highly organized, manage multiple priorities, and thrive in a fast-paced environment. Some experience in drug development, manufacturing, CMC, or a related scientific field is preferred. The successful candidate will be proactive, detail-oriented, and eager to learn and contribute across a range of activities. The team values in-person collaboration, requiring three days per week in the Waltham office. The role is for someone passionate about developing innovative medicines and making a meaningful impact.

Requirements

Master’s degree in life sciences, engineering, pharmaceutical sciences, biotechnology or a related discipline with 0-2 years relevant experience, OR Bachelor’s degree with 2-4 years of relevant experience.
Experience in a biopharmaceutical, biotechnology, or regulated drug development environment is required.
Strong organizational skills with the ability to manage multiple priorities, track deliverables, maintain timelines, and follow up on action items.
Excellent written and oral communication skills, with the ability to prepare clear meeting summaries, trackers and cross-functional messages.
Ability to work independently while knowing when to escalate risks, issues or delays.
Proficiency with standard business and project-management tools, such as Microsoft Office, Sharepoint, Smartsheet or similar systems.
Ability to operate in a fast-paced, timeline-driven environment and adapt to changing program priorities.

Nice To Haves

Experience in manufacturing, drug development, process development, analytical or other CMC-related functions is preferred.
Basic understanding of regulated documentation practices, GMP concepts or CMC development workflows is preferred.

Responsibilities

Support CMC program execution by assisting the CMC Program Manager with day-to-day coordination of late-stage manufacturing, process development, analytical, quality, and regulatory readiness activities.
Manage CMC documentation workflows, including drafting support, formatting, version control, review routing, comment resolution tracking, approvals, and archival of key program documents.
Maintain integrated CMC trackers and timelines for deliverables such as batch records, protocols, reports, specifications, comparability documentation, stability updates, regulatory content, and manufacturing readiness milestones.
Prepare meeting materials and outputs, including agendas, decision logs, action-item trackers, meeting minutes, dashboards, and follow-up communications for CMC team meetings and governance reviews.
Track risks, issues, decisions, and dependencies across CMC workstreams and escalate delays, gaps, or cross-functional misalignments to the CMC Program Manager.
Support external partner and CDMO coordination by managing document exchanges, action trackers, meeting follow-ups, deliverable status updates, and communication records.
Contribute to continuous improvement of CMC project management tools and processes, including templates, trackers, document control practices, reporting formats, and readiness checklists.