Oruka Therapeutics

Oruka Therapeutics

Associate/Sr. Associate - CMC Project Management & Operations

Waltham, Massachusetts, United States · Senior

Sponsorship not specified$104k-$125kDetected 16 days ago
Project ManagementGMPCommunicationCollaborationOrganizational SkillsMicrosoft OfficeSharePoint

About the role

  • 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.

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.
  • 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.
  • ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases.
  • 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.

Requirements

  • 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.
  • 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.
  • Waltham, MA Hybrid - onsite 3 days/week required
  • Strong organizational skills with the ability to manage multiple priorities, track deliverables, maintain timelines, and follow up on action items.

Nice to have

  • Experience in manufacturing, drug development, process development, analytical or other CMC-related functions is preferred.
  • 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.
  • Salary Range for the Role
  • $104,000 - $146,000 USD

Benefits

  • Competitive salary and benefits package.

Company info

  • 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
  • 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
  • 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
  • Reports to: CMC Program Manager
  • Position Overview:
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This listing is sourced directly from Oruka Therapeutics's careers page and normalized into a canonical job model.