Scientist, Downstream, Process Development and Manufacturing (PD/MFG) (Biologics)

Oruka Therapeutics•Waltham, MA

4d•Hybrid

About The Position

Oruka Therapeutics is developing novel biologics for chronic skin diseases. They are seeking a motivated Process Development individual to lead downstream pre-clinical to early stage enabling process development, optimization, scale-up and transfer of manufacturing activities. This role involves early-stage process development, tox batch production, optimization, scale up to GMP and late stage pivotal development, supporting IND filing. The position is in a fast-paced environment requiring drafting high-quality reports, finalization of source documents, and active participation in writing regulatory submissions. The successful candidate will be an integral part of a growing team contributing to the development of best-in-class biotherapeutics.

Requirements

Bachelor’s or Master’s degree in Biochemistry, Biochemical Engineering, Biotechnology, or a related field.
Minimum of 4 years of relevant industry experience in the development, scale-up, and technology transfer of downstream processes for biologics.
Significant laboratory experience with early-stage development.
Expertise in purification process optimization with an emphasis on scale-up, process robustness, and facility fit.
Solid understanding of all downstream unit operations, process parameters, product quality, and troubleshooting strategies enabling successful scale up.
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.

Nice To Haves

Direct hands-on experience with monoclonal antibodies is a plus.

Responsibilities

Oversee the transfer of manufacturing processes from pre clinic to early-stage development to 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 clinical manufacturing.
Build strong relationships and partners cross-functionally with process development, analytical, formulation, quality, regulatory and program management.
Oversee tox production and GMP manufacturing campaigns ensuring seamless execution, timely completion and handoff to drug product manufacturing teams.
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).