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Oruka Therapeutics · 1 month ago

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

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 downstream late-stage manufacturing activities, ensuring process development, troubleshooting, and compliance with regulatory standards.

BiotechnologyHealth CareMedical

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

Qualification

Downstream process developmentManufacturing ScienceTechnologyPurification process optimizationRegulatory compliance knowledgeMonoclonal antibodies experienceDesign-of-experiments (DoE)Data analysis skillsPeople management skillsCommunication skillsStrategic mindset

Required

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 development and life-cycle management

Must have a solid understanding of all downstream unit operations, process parameters, product quality, and troubleshooting strategies enabling successful execution of phase appropriate manufacturing campaigns

Demonstrated track record of successful tech transfers to CDMOs with an eye towards late stage and commercial process development

Must have direct experience or exposure to transition of processes from early stage to late stages such as process characterization, FMEA and PPQ campaigns, with emphasis on phase appropriate control strategy

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

Self-starter with a strategic mindset and ability to thrive in a fast-paced, collaborative environment