About the position
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. 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.
Responsibilities
- Lead liquid drug product process development, technology transfer, and GMP aseptic manufacturing at external CDMO partners
- Serve as an aseptic fill finish subject matter expert and support manufacturing process readiness, sampling plans, and in-process control strategy for drug products in vials and pre-filled syringes
- Liaise with drug product formulation and analytical SMEs to develop robust formulations, processes, methods and unit operations in support of GMP manufacturing of high concentration biologic drug products
- Lead and support gap analysis, equipment and raw material risk assessment, filter validation studies, in-use compatibility analysis, transportation, and E&L assessment in a phase appropriate manner
- Serve as person-in-plant (PIP) during drug product manufacturing campaigns
- Liaise with stakeholders to support timely approval and execution of SOPs, batch records, lot release, retests, in-process sampling plans, stability protocols/reports, retains, change controls, deviations, OOS/OOT investigations, CAPAs and campaign reports
- Ensure stakeholders such as analytical, formulation, clinical supply chain, quality and PM teams are aligned with overall drug product timelines
- Facilitate critical cross functional decisions within the CMC team while keeping program level stakeholders informed at regular interval
- Collaborate with drug substance manufacturing and clinical supply chain stakeholders ensuring robust clinical supply forecasts
- Develop road map for late-stage process development, process characterization, and PPQ campaigns
- Assist in the diligence process to select clinical and commercial CDMO vendors
- Track internal and external manufacturing deliverables and adapt to changing priorities keeping corporate CMC objectives at the forefront
- Foster a culture of collaboration, communication, critical thinking, innovation, and continuous improvement
- 20-25% travel in support of diligence and campaign execution at CDMOs
Requirements
- Master’s or a PhD in a scientific discipline with 10-15 years of relevant experience in aseptic drug product development and manufacturing of biologics
- Must have prior experience managing drug product development and GMP manufacturing in vials and pre-filled syringes
- Exposure to supporting or leading device development (pre-filled syringes and auto-injectors) is a plus
- Significant experience developing robust unit operations towards large scale drug product manufacturing campaigns
- Experience with liquid formulation studies, process development, container closure compatibility studies, device functionality studies and QTPP development
- In-depth knowledge of aseptic regulations required to manage multi country regulatory filings
- Demonstrated track record of successful tech transfers to commercial CDMOs with an eye towards late stage and commercial launch
- Strong scientific skills with operational experience in tracking multiple activities, deliverables, timelines, contracts and budgets
- 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
- Strong sense of urgency and ability to deliver in a highly fast paced environment
Nice-to-haves
- Experience with device development (pre-filled syringes and auto-injectors)
Benefits
- 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.
