Associate/Sr. Associate - CMC Project Management & Operations

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

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 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 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.
• 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 to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. 

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

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.