Associate Director, Downstream, Manufacturing Sciences and Technology; Biologics

Associate Director, Downstream, Manufacturing Sciences and Technology (Biologics) late

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.

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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, Downstream, Manufacturing Sciences and Technology (Biologics)

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

Position Overview:

We are seeking an experienced and motivated MSAT (Manufacturing Science and Technology) leader to lead downstream late-stage and pivotal enabling optimization, scale-up and transfer of manufacturing activities. In this role, the ideal candidate will be responsible for process development, troubleshooting production issues, data analysis, and ensuring compliance with regulatory standards to maintain product quality. The successful candidate will be involved in late-stage drug substance manufacturing and process validation activities in support of BLA filing.

This role involves working in a fast-paced environment and drafting high quality reports, finalization of source documents and active participation in writing regulatory submissions. You will be an integral part of a growing team with an opportunity to contribute towards developing best in class biotherapeutics.

Key Responsibilities:

• Oversee the transfer of manufacturing processes from late-stage development to large-scale production at the CDMOs for multiple programs.
• Work with CDMOs to identify gaps and implement improvements towards enhancing product quality, robustness, and cost-effectiveness with line of sight to commercial manufacturing.
• Build strong relationships and partner cross functionally with process development, analytical, formulation, quality, regulatory and program management.
• Oversee GMP manufacturing campaigns ensuring seamless execution, timely completion and handoff to drug product manufacturing teams.
• Partner with late-stage process characterization and MSAT teams and develop robust control strategy enabling successful PPQ DS campaigns
• 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).
• Perform MFG/MSAT risk assessment activities in a phase appropriate manner ensuring proper measures are in place in support of production and filing requirements.
• 20-25% travel in support of manufacturing activities at CDMOs.

Qualifications:

• Master’s or a PhD degree in biochemistry, biochemical engineering, biotechnology or equivalent with at least 8 years of relevant experience developing, scaleup, and transfer of downstream processes for biologics.
• Significant experience managing manufacturing in an MSAT environment. Direct hands‑on experience with monoclonal antibodies is a plus.
• Expertise in purification process optimization with an emphasis on scale-up, scale-down models, process robustness, facility fit and overall commercial readiness.
• In depth knowledge of CMC, quality and compliance, as well as regulatory aspects of biopharmaceutical…