Associate/Sr. Associate - CMC Project Management & Operations

About Oruka Therapeutics

Oruka Therapeutics is creating advanced biologic therapies aimed at establishing a new benchmark for chronic skin disease treatment. Its focus includes conditions such as plaque psoriasis, with the goal of helping patients achieve deep and durable disease control with dosing as rarely as once or twice each year. The company is building a portfolio of engineered antibodies designed to address the underlying biology of plaque psoriasis and other inflammatory and dermatologic disorders.

The company is also looking for people who want more than a conventional job — individuals who are excited to help shape a growing organization and contribute to an inclusive, collaborative culture.

Role Summary

Oruka Therapeutics is hiring an Associate/Sr. Associate for CMC Project Management and Operations to support critical chemistry, manufacturing and controls initiatives across clinical-stage programs. This position reports to the CMC Program Manager and is based in Waltham, Massachusetts, with an onsite expectation of three days per week.

The right candidate will bring strong communication skills, a structured approach to work, and comfort partnering with cross-functional teams. The role requires someone who can stay organized while handling several priorities in a fast-moving environment, and who is eager to grow while contributing across a broad set of CMC-related activities.

What You Will Do

• Assist the CMC Program Manager with the daily coordination of late-stage manufacturing, process development, analytical, quality, and regulatory readiness work.
• Help maintain CMC document flows, including drafting support, formatting, document version control, routing for review, tracking comments, collecting approvals, and archiving key materials.
• Keep integrated trackers and timelines updated for deliverables such as batch records, protocols, reports, specifications, comparability packages, stability updates, regulatory materials, and manufacturing readiness milestones.
• Prepare meeting agendas, decision logs, action trackers, minutes, dashboards, and follow-up communications for CMC team meetings and governance discussions.
• Monitor risks, issues, decisions, and dependencies across workstreams, and escalate delays, gaps, or misalignment to the CMC Program Manager when needed.
• Support coordination with external partners and CDMOs by handling document exchanges, action tracking, status updates, meeting follow-ups, and communication records.
• Help improve project management tools and workflows, including templates, trackers, document control methods, reporting formats, and readiness checklists.

Qualifications

• A master’s degree in life sciences, engineering, pharmaceutical sciences, biotechnology, or a related field with 0-2 years of relevant experience, or a bachelor’s degree with 2-4 years of relevant experience.
• Prior experience in a biopharmaceutical, biotechnology, or other regulated drug development setting is required.
• Background in manufacturing, drug development, process development, analytical work, or another CMC-related function is preferred.
• Strong planning and organizational abilities, with the capacity to manage multiple priorities, deadlines, timelines, and follow-up items.
• Excellent written and verbal communication skills, including the ability to create clear summaries, trackers, and cross-functional updates.
• Ability to work independently while recognizing when to escalate risks, issues, or delays.
• Comfort using standard business and project management tools such as Microsoft Office, SharePoint, Smartsheet, or similar platforms.
• Ability to thrive in a fast-paced, timeline-driven setting and adapt to shifting program needs.
• Basic familiarity with regulated documentation practices, GMP concepts, or CMC development workflows is preferred.

Compensation

The selected candidate will receive a compensation package that includes a competitive base salary, equity, and a performance-based bonus opportunity. For Waltham, MA, the expected salary range is $104,000 to $125,000 for the Associate level and $130,000 to $146,000 for the Sr. Associate level. The actual offer will depend on factors such as relevant experience, industry background, and education.

The overall salary range for this role is $104,000 to $146,000 USD.

What We Offer

• The opportunity to help bring innovative medicines to patients as part of a dynamic startup environment.
• A competitive compensation and benefits package.
• A supportive and inclusive workplace where people are encouraged to bring their authentic selves to work.
• Opportunities for learning, growth, and professional development.

Work Location

This is a hybrid role based in Waltham, MA, with three onsite days required each week.