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Associate Director, Analytical Development, Tech Ops (Biologics)

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. We have raised nearly $500M since inception in February 2024 from top-tier investors and our first program is expected to be in the clinic in the first quarter of 2025.  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, Analytical Development, Tech Ops (Biologics)       

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

Position Overview:

We are seeking an experienced and motivated candidate to lead the analytical function within the CMC team, in support of early-to-late-stage clinical trials. In this role, you will partner with tech ops and quality teams to ensure phase-appropriate analytical methods are developed, qualified and/or validated for release and stability testing of Oruka assets.

You are an ideal candidate for this role if you enjoy developing, optimizing and trending performance for various analytical assays in support of release and stability testing of biologics. In this role, you will have the opportunity to work to optimize assays from pre-IND through commercialization and manage lifecycle of the assays. You will manage stability studies and collaborate with quality, regulatory and clinical teams as new data arrive and impacts shelf life. 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 across US, Canada and EU.

Key Responsibilities:

  • Lead external method development, optimization and qualification/validation efforts across liquid chromatography, capillary electrophoresis, spectrophotometric and bioassay (among others) for release and stability testing of clinical trial materials
  • Manage multiple non-GMP and GMP stability studies for drug substance (DS) and drug product (DP) batches for multiple programs
  • Leverage stability data to project shelf-life of both DS and DP supply through trending analysis
  • Develop strategies to establish characterization and comparability packages across various DS/DP lots
  • Support process and manufacturing teams towards implementation of relevant analytical methods
  • Work closely with cross-fuctional stakeholders (QA, Regulatory, Clinical Supply Chain) for shelf-life extension of clinical material to support ongoing clinical trials
  • Partner with internal and external stakeholders to justify and establish DS/DP protocols and specifications
  • Work with CDMO partners to perform root cause analysis and investigations to support OOS/OOT results that may arise during stability studies
  • Contribute to IND/BLA sections pertaining to analytical methods, stability studies, characterization and analytical comparability
  • Lead the diligence process to select clinical and commercial CDMO vendors
  • Partner with operations, legal, and finance groups to finalize confidentiality, master service and contractual agreements
  • 20-25% travel in support of diligence and campaign execution at the CDMOs

Qualifications:

  • Master’s (10+ years) or a PhD (6+ years) with experience in a scientific discipline with relevant experience in analytical development and/or QC. Experience with monoclonal antibodies is a requirement.
  • 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)
  • Deep understanding of ICH guidelines for method development/qualification and validation as well as regulatory expectations in US, Canada, EU, etc.
  • Experience managing multiple stability studies, protocol development and performing trending analysis, OOS/OOT investigations, root cause analysis, etc.
  • 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 $175,000 to $200,000. 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

$175,000 - $200,000 USD

What We Offer:

  • A chance to be part of a vibrant small-company culture where your work can directly impact bringing new medicines to patients.
  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.

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