Associate Director, Upstream, Manufacturing Sciences & Technology (Biologics)

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, Upstream, Manufacturing Sciences & Technology (Biologics)  

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

Position Overview: 

We are seeking an experienced and motivated Associate Director to lead late-stage upstream manufacturing activities. This role will be instrumental in overseeing tech transfer, scale-up and process validation activities at CDMOs. The ideal candidate will collaborate cross-functionally within the CMC team including downstream, analytical, and drug product and other stakeholders such as QA, regulatory, and program management.  The successful candidate will help shape late-stage CMC strategy, contribute to gap assessments, and support regulatory submissions in a fast-paced, innovative environment. You will be an integral part of a growing team with an opportunity to contribute towards developing best in class biotherapeutics.

Key Responsibilities:

• Serve as a subject matter expert for upstream cell culture development and manufacturing at CDMOs.
• Lead tech transfer and scale-up activities, ensuring robust, consistent, and cost-effective upstream processes.
• Support batch record review, in-process sampling plans, release protocols, review SOPs, change controls, deviations, OOS/OOT investigations, and CAPAs.
• Serve as person-in-plant (PIP) during drug substance manufacturing campaigns.
• Conduct risk assessments and gap analysis to support late-stage development and commercial readiness
• Manage drug substance manufacturing campaigns and timelines ensuring seamless execution, timely completion and handoff to downstream teams.
• Apply QbD principles to define process parameters and product quality attributes that support late-stage process optimization and control strategy.
• Analyze and incorporate data from process and manufacturing runs in relevant regulatory filings.
• Coordinate, review and draft relevant sections of the regulatory filings (IND, IMPD) ensuring timely completion of relevant CMC sections.
• Travel up to 20-25% to support CDMO activities.

Qualifications:

• PhD or Master’s in an Engineering discipline or Biological Sciences field with at least 8 years of experience in upstream manufacturing from relevant work in a manufacturing sciences and technology (MS&T) environment.
• Strong expertise in CHO cell culture, scale up, media formulations and bioreactor operations. Experience developing cell cultue processes for monolclonal antibodies is a plus.
• Must have solid understanding of process parameters, product quality, and troubleshooting strategies enabling successful execution of phase appropriate manufacturing campaigns.
• Track record of successful tech transfers to CDMOs with direct experience in late stage clinical and commercial manufacturing.
• Experience in late stage manufacturing, including process characterization, FMEA, and PPQ campaigns.
• Direct experience in robust data analysis via industry standard statistical tools.
• In depth knowledge of cGMP, ICH, WHO and FDA/EMA guidelines and experience utilizing them in a phase appropriate manner.
• Hands on experience with scale-up/down models, process monitoring, facility fit and overall commercial readiness.
• Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders.
• Self-starter with a strategic mindset and ability to thrive in a fast-paced, collaborative environment.<