--- title: 'Associate/Sr. Associate - CMC Project Management & Operations at Oruka Therapeutics' canonical: 'https://feeny.ai/job/associate-sr-associate-cmc-project-management-operations-oruka-therapeutics-nxqjhp0d3ycd' type: 'job' last_seen: '2026-09-09' --- # Associate/Sr. Associate - CMC Project Management & Operations at Oruka Therapeutics - **Company:** Oruka Therapeutics - **Location:** Waltham Massachusetts, United States - **Compensation:** $104k–$146k - **Posted:** 2026-07-06 - **Last confirmed live:** 2026-09-09 - **Apply:** https://job-boards.greenhouse.io/oruka/jobs/5293846008 ## Job description 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](http://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 - Salary Range for the Role $104,000—$146,000 USD 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. ## About Oruka Therapeutics ## Company Overview - **One-liner**: Oruka Therapeutics is a clinical-stage biotechnology company developing potentially best-in-class monoclonal antibodies with extended half-lives to transform the treatment of psoriasis and other chronic inflammatory skin diseases by enabling high rates of complete disease clearance with as few as one or two doses per year. - **Entity Type**: Public (Nasdaq: ORKA) - **Headquarters**: Waltham, Massachusetts, United States (with a second office in Menlo Park, California) - **Founded**: Not publicly available - **Founders**: Not publicly available (the company was formed as a spinout of Paragon Therapeutics, which discovered its antibody pipeline) ## Core Business - **Primary industry**: Biotechnology – dermatology and inflammatory disease therapeutics - **Target customers**: Patients with plaque psoriasis, psoriatic arthritis, hidradenitis suppurativa, and other inflammatory conditions; physicians and healthcare providers; payers and health systems - **Mission**: *“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.”* [orukatx.com](https://orukatx.com/) ## Products & Services - **ORKA-001**: An investigational monoclonal antibody targeting IL-23p19, engineered for extended circulation time. Designed as a potentially best-in-class therapy for moderate-to-severe plaque psoriasis, with the potential for dosing once or twice per year. Currently in Phase 2b clinical trial (EVERLAST-B). [orukatx.com](https://orukatx.com/our-pipeline/) - **ORKA-002**: An investigational monoclonal antibody targeting IL-17A/F, also engineered for half-life extension. Aimed at psoriasis, psoriatic arthritis, and hidradenitis suppurativa, with potential dosing two to three times per year. Currently in Phase 1/2. [orukatx.com](https://orukatx.com/our-pipeline/) - **ORKA-003**: A preclinical sequential combination regimen of ORKA-002 and ORKA-001, designed to deliver rapid responses with an ideal maintenance profile. [orukatx.com](https://orukatx.com/our-pipeline/) - **ORKA-021**: Preclinical stage candidate (details not fully disclosed). [orukatx.com](https://orukatx.com/our-pipeline/) ## Market Standing - **Valuation/Market Cap**: Not publicly available at this time (company went public via IPO; market cap fluctuates daily). Latest financial data should be obtained from SEC filings. - **Key Metric**: As a clinical-stage public company, Oruka has no approved products yet. Funding and operational runway are funded by its IPO proceeds; exact amounts not provided in search results. - **Notable Investors/Partners**: Discovery and engineering partner: Paragon Therapeutics (also parent of Apogee Therapeutics and Spyre Therapeutics). Investor base includes public market shareholders post-IPO. - **Growth Signals**: - Two co-lead programs advancing through clinical trials (Phase 1 data expected; Phase 2 ongoing). - Team expanding rapidly, with multiple job openings across scientific, clinical, and corporate functions. - Dual-location offices (Boston area and Bay Area) to attract top biotech talent. ## Competitive Advantages - **Advanced antibody engineering**: Incorporates half-life extension technology (e.g., YTE mutations) to dramatically prolong circulation time, aiming for the longest dosing intervals in the class (1–2 doses per year vs. standard 4–12 times per year). - **Proven mechanisms**: Targets IL-23p19 and IL-17A/F—validated, blockbuster pathways in psoriasis—but with enhanced pharmacokinetics to maximize efficacy and patient convenience. - **Discovery engine**: Pipeline originated from Paragon Therapeutics, a proven antibody engineering shop that also spawned Apogee and Spyre, indicating a repeatable model for creating best-in-class molecules. - **Focus on complete clearance**: Emphasizes “complete disease clearance” (e.g., PASI 100) as a goal, not just improvement—a higher bar than many current treatments. ## Strategic Focus - **Near-term**: Generate Phase 1 safety and pharmacokinetics data for ORKA-001 and ORKA-002; advance EVERLAST-B (Phase 2b for ORKA-001) and ORCA-SURGE (Phase 2 for ORKA-002); initiate trials in additional indications (psoriatic arthritis, hidradenitis suppurativa). - **Long-term**: Build a fully integrated biopharmaceutical company capable of commercializing novel biologics, potentially expanding beyond dermatology into other inflammatory diseases. - **Organizational growth**: Aggressively hiring across all functions (clinical development, medical affairs, regulatory, CMC, finance, BD, etc.) to scale from early-stage to late-stage organization. ## Why Work Here - **Mission-driven**: A chance to directly impact millions of patients living with chronic skin diseases—offering the potential for life-changing freedom from disease. - **Startup culture with public-company resources**: Small, nimble team (“wear multiple hats”) but with the backing of a Nasdaq listing, equity grants, and competitive compensation. - **Flexible work environment**: Remote-first policy with hybrid options (3 days/week) if located near Waltham, MA or Menlo Park, CA offices. [greenhouse.io](https://job-boards.greenhouse.io/oruka/jobs/5202407008) - **Compensation & benefits**: Competitive base salary (e.g., Senior Scientific Communications Manager salary range $161k–$187k), equity, performance bonus, and professional development opportunities. [greenhouse.io](https://job-boards.greenhouse.io/oruka/jobs/5202407008) - **Team culture**: Described as “vibrant startup culture,” “supportive and inclusive,” with emphasis on bringing “authentic selves to work.” Opportunities for growth in a fast-moving, high-autonomy environment. - **Top-tier location**: Offices in both the Boston/Cambridge biotech hub and the Bay Area, giving employees access to two of the strongest life science ecosystems. ## Sources 1. [orukatx.com – Home](https://orukatx.com/) 2. [orukatx.com – Who We Are](https://orukatx.com/who-we-are/) 3. [orukatx.com – Pipeline](https://orukatx.com/our-pipeline/) 4. [orukatx.com – Join Us](https://orukatx.com/join-us/) 5. [greenhouse.io – Senior Scientific Communications Manager job posting](https://job-boards.greenhouse.io/oruka/jobs/5202407008) ## Other roles at Oruka Therapeutics - [Sr. Associate/Manager Project Management & Operations](https://feeny.ai/job/sr-associate-manager-project-management-operations-oruka-therapeutics-waltham-vkjrt9srrzv7) — Waltham Massachusetts, United States - [Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization](https://feeny.ai/job/senior-manager-associate-director-clinical-monitoring-strategy-optimization-fz8n0jqr0913) — Menlo Park California, United States / Waltham Massachusetts, United States - [Associate Director, Regulatory CMC (Biologics)](https://feeny.ai/job/associate-director-regulatory-cmc-biologics-oruka-therapeutics-waltham-8tegt1p70qg9) — Waltham Massachusetts, United States - [Associate Director/Director, Clinical Pharmacology](https://feeny.ai/job/associate-director-director-clinical-pharmacology-oruka-therapeutics-remote-mszse4yzs07a) - [Administrative Assistant](https://feeny.ai/job/administrative-assistant-oruka-therapeutics-waltham-w7s67gb88efv) — Waltham, MA - [Sr. Manager/Associate Director, Regulatory Affairs](https://feeny.ai/job/sr-manager-associate-director-regulatory-affairs-oruka-therapeutics-menlo-park-810qkwnjxqp4) — Menlo Park, CA / Waltham, MA - [Director, Clinical Operations](https://feeny.ai/job/director-clinical-operations-oruka-therapeutics-waltham-massachusetts-dmf2nbp3y8nt) — Waltham Massachusetts, United States - [Director of Biostatistics](https://feeny.ai/job/director-of-biostatistics-oruka-therapeutics-remote-v8hjmy2gjd5v) - [Medical Science Liaison-Southeast](https://feeny.ai/job/medical-science-liaison-southeast-oruka-therapeutics-remote-0tptf8yxr814) - [Medical Science Liaison-South Central](https://feeny.ai/job/medical-science-liaison-south-central-oruka-therapeutics-remote-4j3fngt21w29)