Associate​/Sr. Associate - CMC Project Management & Operations

Associate/Sr. Associate - CMC Project Management & Operations

Waltham, Massachusetts, United States

About Us:

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best‑in‑class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases.

For more information, visit

Job Title: Associate/Sr. Associate – CMC Project Management and Operations

Location: Waltham, MA (Hybrid – onsite 3 days/week required)

Reports to: CMC Program Manager

Position Overview: We are seeking a highly motivated Associate or Sr. Associate to join our dynamic growing team as we work to set a new standard in treating chronic skin diseases. This role will be pivotal in developing and managing systems to support critical CMC projects and driving the success of our clinical‑stage programs. The ideal candidate will have strong written and verbal communication skills, enjoy working with cross‑functional teams and stakeholders, be highly organized, and able to manage multiple priorities in a fast‑paced environment.

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.

• 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 work streams 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.

• 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.
• Experience in manufacturing, drug development, process development, analytical, or other CMC‑related functions is preferred.
• 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 elevate 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.
• Basic understanding of regulated…