Scientist, Downstream, Process Development and Manufacturing; PD​/MFG; Biologics

Scientist, Downstream, Process Development and Manufacturing (PD/MFG) (Biologics)

Waltham, Massachusetts, United States

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.

Scientist, Downstream, Process Development and Manufacturing (PD/MFG) (Biologics)

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

We are seeking a motivated Process Development individual to lead downstream pre‑clinical to early‑stage enabling process development, optimization, scale‑up and transfer of manufacturing activities. In this role the candidate will be responsible for early‑stage process development, tox batch production, optimization, scale up to GMP and late‑stage pivotal development. The successful candidate will be involved in pre‑clinical development to pre‑pivotal early‑stage development in support of IND filing and will draft high‑quality reports, finalize source documents and actively participate in writing regulatory submissions.

• Oversee the transfer of manufacturing processes from pre‑clinical to early‑stage development to production at CDMOs for multiple programs.
• Work with CDMOs to identify gaps and implement improvements that enhance product quality, robustness, and cost‑effectiveness with a line of sight to clinical manufacturing.
• Build strong relationships and partners cross‑functionally with process development, analytical, formulation, quality, regulatory and program management.
• Oversee tox production and GMP manufacturing campaigns ensuring seamless execution, timely completion and handoff to drug product manufacturing teams.
• Serve as person‑in‑plant (PIP) during drug substance manufacturing campaigns.
• Partner with stakeholders to support timely approval and execution of reports, batch records, in‑process sampling plans, review SOPs, change controls, deviations, OOS/OOT investigations, and CAPAs.
• Support regulatory filings by authoring high‑quality reports enabling timely submissions for multiple jurisdictions (INDs, CTAs).
• Travel 15‑20% in support of manufacturing activities at CDMOs.

• Bachelor’s or Master’s degree in Biochemistry, Biochemical Engineering, Biotechnology, or a related field.
• Minimum of 4 years of relevant industry experience in the development, scale‑up, and technology transfer of downstream processes for biologics.
• Significant laboratory experience with early‑stage development and direct hands‑on experience with monoclonal antibodies is a plus.
• Expertise in purification process optimization emphasizing scale‑up, process robustness, and facility fit.
• Solid understanding of all downstream unit operations, process parameters, product quality, and troubleshooting strategies enabling successful scale‑up.
• Direct experience in design‑of‑experiments (DoE) and robust data analysis via industry‑standard statistical tools.
• Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders.

• An appropriate financial package will include a competitive base salary, equity, and a performance‑related bonus opportunity.
• Anticipated salary range for candidates who will work in the 130,000 corridor is $146,000. The final salary offered will depend on factors such as experience, industry, and education.

• Opportunity to be part of a vibrant startup culture where work directly impacts bringing new medicines to patients.
• Competitive salary and benefits package.
• Supportive and inclusive team environment encouraging authenticity.
• Opportunities for professional growth and development.

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.

We are a federal contractor and require equal employment opportunity for qualified people with disabilities. The law requires that we measure progress toward a goal of having at least 7% of our workforce as people with disabilities, and we therefore provide the appropriate voluntary self‑identification opportunity.