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

Associate/Sr. Associate - CMC Project Management & Operations

Waltham, Massachusetts, United States

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.

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As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.

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/ 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, driving the success of our clinical stage programs. This role reports to the CMC Program Manager. The ideal candidate will have strong written and verbal communication skills and enjoy working with cross-functional teams and stakeholders.

They should be highly organized, able to manage multiple priorities, and comfortable working 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.

Our team values in-person collaboration, and we expect this role to work from our Waltham office three days per week. We're looking for someone who shares our passion for developing innovative medicines and is eager to make a meaningful impact.

Key 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 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.

Qualifications

• 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…