---
title: 'Director, Analytical Development and Validation, Tech Ops (Biologics) at Oruka Therapeutics'
canonical: 'https://feeny.ai/job/director-analytical-development-and-validation-tech-ops-biologics-oruka-47s5v1k9j0gb'
type: 'job'
last_seen: '2026-09-09'
---

# Director, Analytical Development and Validation, Tech Ops (Biologics) at Oruka Therapeutics

- **Company:** Oruka Therapeutics
- **Location:** Waltham Massachusetts, United States
- **Compensation:** $213k–$240k
- **Work type:** remote
- **Posted:** 2026-04-10
- **Last confirmed live:** 2026-09-09
- **Apply:** https://job-boards.greenhouse.io/oruka/jobs/5184631008

## 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: Director, Analytical Development and Validation, Tech Ops (Biologics)

Location: Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week. Remote may be considered.

Role Overview:

The Director of Analytical Development and Validation will provide scientific and strategic leadership for late-stage analytical activities supporting the development, validation, and lifecycle management of biologic drug products, with a focus on monoclonal antibodies. This role will lead method validation and comparability efforts in support of BLA/MAA submissions, process changes, and commercial readiness, while partnering closely with CMC, Quality, Regulatory Affairs, and external partners.

The ideal candidate is a hands-on leader with deep expertise in analytical method validation, device functional testing, regulatory expectations for late-stage biologics, and the ability to guide teams through complex technical and compliance-driven milestones. This role is highly visible within the CMC team and a pivotal addition to our growing organization where you will play an integral role in supporting multiple programs’ analytical activities in support of releasing supplies for clinical trials and preparing for commercialization across US, Canada and EU.

Key Responsibilities:

- Lead late-stage analytical development activities for biologics, including method transfer & validation for release, stability, characterization and device functional testing assays.
- Provide subject matter expertise for ICH Q2/Q14, USP/EP/JP, and global regulatory expectations related to analytical methods.
- Oversee validation of assays including potency/bioassays, purity and impurities (SEC, CE-SDS, icIEF, HPLC), identity, characterization, residuals and device functional testing.
- Experience with PFS and Autoinjector functional testing is required, including validation per ISO guidance(s).
- Drive analytical strategies to support BLA/MAA submissions, post-approval changes, and comparability studies.
- Partner with Process Development, Manufacturing, Quality, and Regulatory to support late-stage development, tech transfer, and commercial launch readiness.
- Support analytical risk assessments, control strategy development, and lifecycle management activities.
- Serve as analytical lead for regulatory interactions, including agency questions and inspections.
- Build, mentor, and lead a high-performing analytical development team (internal and/or external).
- Set technical direction, priorities, and timelines for late-stage analytical deliverables.
- Manage and provide technical oversight to CDMOs and contract laboratories.
- Review and approve protocols, validation reports, development reports, and regulatory documentation.
- 10-20% travel is required for this role.

Qualifications:

- Experience with monoclonal antibodies and PFS/Auto Injectors is a requirement.
- Director: Master’s (10+ years) or PhD (7+ years) with experience in a scientific discipline with relevant experience in analytical development and/or QC.
- Relevant industry experience in method development, qualification, validation and method transfer in support of ongoing development and/or commercialization of biologics.
- Experience with methods including but not limited to U/HPLC, Capillary Electrophoresis, Spectrophotometer, Bioassay (ELISA and Cell-Based), device functional testing per ISO guidance.
- Deep understanding of ICH guidelines for method development/qualification and validation as well as regulatory expectations in US, Canada and EU.
- Experience managing multiple stability studies, protocol development and performing trending analysis, OOS/OOT investigations, root cause analysis, etc.
- Experience with late-phase comparability studies, especially geared toward commercialization.
- Experience in authoring/contributing to regulatory filings, specifically Module 3 for analytical methods and stability studies
- Demonstrated track record of successful tech transfers between CDMOs with an eye towards late-stage development and commercial launch.
- Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders.
- Must have a creative and strategic attitude with the ability to work in a fast-paced environment.

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, who will work in Waltham, MA is $213,000-240,000. 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. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day. Salary Range for the Role $213,000—$240,000 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/Sr. Associate - CMC Project Management & Operations](https://feeny.ai/job/associate-sr-associate-cmc-project-management-operations-oruka-therapeutics-nxqjhp0d3ycd) — Waltham Massachusetts, United States
- [Associate Director/Director, Clinical Pharmacology](https://feeny.ai/job/associate-director-director-clinical-pharmacology-oruka-therapeutics-remote-mszse4yzs07a)
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- [Director, Clinical Operations](https://feeny.ai/job/director-clinical-operations-oruka-therapeutics-waltham-massachusetts-dmf2nbp3y8nt) — Waltham Massachusetts, United States
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