Back to jobs
New

Associate Director/Director, Analytical Development and Validation, Tech Ops (Biologics)

Remote; Waltham, Massachusetts, United States

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 Director/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 Associate Director/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 validation, method qualification, and method transfer 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
  • 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
  • Manage and provide technical oversight to CDMOs and contract
  • Review and approve protocols, validation reports, development reports, and regulatory
  • 20-25% travel is required for this role.

Qualifications: 

  • Experience with monoclonal antibodies and PFS/Auto Injectors is a
  • Associate Director: Master’s (7+ years) or PhD (5+ years) with experience in a scientific discipline with relevant experience in analytical development and/or QC.
  • 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
  • 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
  • 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

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 $182,000-208,000 for Associate Director and $213,000-240,000 for Director. 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

$182,000 - $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.

Create a Job Alert

Interested in building your career at Oruka Therapeutics? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Education

Select...
Select...
Select...
Select...
Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Oruka Therapeutics’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.