- Pay
- $182–208k
- Where
- Menlo Park, CA · Waltham, MA · Remote, US · Remote
- Level
- Senior
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 robustness studies, with a focus on high concentration product development.
Experience with co-formulation products.
Experience with PFS and Autoinjector selection and testing.
Partner with drug product and clinical teams to ensure appropriate container closure selections are made that align with QTPP and clinical needs.
Design and execute in-use compatibility studies to support subcutaneous administration of high concentration biologics.
Partner with analytical development to verify that assays are not impacted by formulation changes.
Drive formulation strategies to support robustness and comparability studies, BLA/MAA submissions, and post-approval changes.
Partner with Process Development, Manufacturing, Quality, and Regulatory to support late-stage development, tech transfer, and commercial launch readiness.
Support formulation risk assessments, control strategy development, and lifecycle management activities.
Serve as formulation lead for regulatory interactions, including agency questions and…