Associate/Sr. Associate - CMC Project Management & Operations

Oruka Therapeutics; Waltham (MA); Hybrid; USD 104,000 - 146,000; Full time

Benefits offered by this job

Equity

Performance bonus

Hybrid work arrangement

Career development opportunities

Inclusive team environment

Job summary

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.

Responsibilities

• 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.

Skills

Project coordination

Documentation management

Cross-functional collaboration

Written & verbal communication

MS Office / SharePoint / Smartsheet

Education

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

Bachelor’s degree in related field

Tools

Microsoft Office

SharePoint

Smartsheet

Job description

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 www.orukatx.com.

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.

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 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.

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 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 documentation practices, GMP concepts, or CMC development workflows is preferred.

Compensation

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance‑related bonus opportunity.
• The anticipated salary range for candidates in Waltham, MA for Associate level is $104,000 – $125,000 and for Sr. Associate is $130,000 – $146,000. The final salary offered will depend on experience, education, and other factors.

What We Offer?

• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
• Competitive salary and benefits package.
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
• Opportunities for professional growth and development.

As set forth in Oruka Therapeutics’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.