Associate Director, Formulation Development, Tech Ops (Biologics)

The posting, as Oruka Therapeutics wrote it

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, Formulation Development, Tech Ops (Biologics)

Location: Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.

Role Overview

The Associate Director of Formulation Development will provide scientific and strategic leadership for early- and late-stage formulation development activities supporting phase-appropriate formulations of biologic drug products, with a focus on monoclonal antibodies, bispecific formats, and co-formulations. This role will lead formulation development and container closure selection, and partner with the Drug Product team to support process development studies across early- and late-stage development. The position will support BLA/MAA submissions, formulation 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 formulation development for complex biologics, spanning early through late-stage development, with a focus on commercial readiness. 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’ formulation activities for clinical trials and preparing for commercialization across the US, Canada, and EU.

The ideal candidate is a hands-on leader with deep expertise in formulation development for complex biologics, spanning early through late-stage development, with a focus on commercial readiness. 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’ formulation activities for clinical trials and preparing for commercialization across the US, Canada, and EU.

Key Responsibilities

• Lead phase-appropriate formulation development workflows for biologics, including selection, optimization, and r

[…]
ctional testing.

• Experience with formulation robustness studies in support of PC/PPQ and commercialization is required.
• Experience with late-phase comparability studies, especially geared toward commercialization.
• Experience in authoring/contributing to regulatory filings, specifically Module 3 for formulation development and stability studies.
• Demonstrated track record of successful tech transfers between CDMOs with an eye toward 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 mindset 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 or Remotely is $182,000 to $208,000. 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
$182,000 — $208,000 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.