Associate Director, Upstream, Manufacturing Sciences
3 weeks ago
Associate Director, Upstream, Manufacturing Sciences & Technology (Biologics)
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. Associate Director, Upstream, Manufacturing Sciences & Technology (Biologics)
Location: Hybrid Waltham, MA required to be in-office 3 days/week.
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. Serve as a subject matter expert for upstream cell culture development and manufacturing at CDMOs.
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.
PhD or Masters 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. 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.
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.
An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
As set forth in Oruka Therapeuticss Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.
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Waltham, MA, United States Oruka Therapeutics Full timeAssociate Director, Upstream, Manufacturing Sciences & Technology (Biologics) 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. Associate Director, Upstream, Manufacturing...
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Waltham, MA, United States Oruka Therapeutics Full timeAssociate Director, Upstream, Manufacturing Sciences & Technology (Biologics) 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. Orukas mission is to offer patients suffering from chronic skin diseases like plaque psoriasis...
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Waltham, United States Oruka Therapeutics Full timeAssociate Director, Upstream, Manufacturing Sciences & Technology (Biologics) 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...
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Waltham, MA, United States Oruka Therapeutics Full timeAbout 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...
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Waltham, MA, United States Oruka Therapeutics Full timeAbout 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...
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Waltham, MA, United States Oruka Therapeutics Full timeAbout 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...
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Waltham, MA, United States Oruka Therapeutics Full timeAbout 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...
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