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Oruka Therapeutics · 1 month ago

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

Waltham, Massachusetts, United States

Full-time

Hybrid

Lead/Staff, Director/Executive

$175K/yr - $200K/yr

8+ years exp

Oruka Therapeutics is developing novel biologics aimed at treating chronic skin diseases. The Associate Director will lead late-stage upstream manufacturing activities, oversee tech transfer, scale-up, and process validation, and collaborate with cross-functional teams to support regulatory submissions.

BiotechnologyHealth CareMedical

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

Qualification

Upstream manufacturingCHO cell cultureTech transferProcess validationData analysisCGMP guidelinesRegulatory submissionsPeople managementCommunication skillsStrategic mindset

Required

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 culture processes for monoclonal 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