Associate Director, CMC Lead, Late-Stage Biologics

Oruka Therapeutics•Waltham, MA

3d•Hybrid

About The Position

Oruka Therapeutics is developing novel biologics for chronic skin diseases, aiming for high clearance rates with infrequent dosing. The Associate Director of CMC Leadership will provide technical and strategic leadership for late-stage CMC activities, focusing on monoclonal antibodies. This role involves supporting development, characterization, validation, licensure application, commercial readiness, and lifecycle management of manufacturing processes. The position is highly visible and requires collaboration with internal CMC leads, Program Management, Quality, Regulatory Affairs, CDMOs, and consultants. The ideal candidate is a technical and matrix leader with hands-on experience in biologics process development and manufacturing, and a proven track record in leading cross-functional teams to achieve complex technical and regulatory milestones for commercialization.

Requirements

Master’s or PhD in relevant disciplines with 10+ (MS) or 7+ (PhD) years of experience in biologics CMC functions including upstream, downstream, analytical, and drug product.
Must have experience leading late- and commercial-stage CMC activities including process characterization, PPQ, BLA, regulatory inspections, life cycle management, and post approval submissions.
Prior matrix leadership experience is highly preferable.
Have led cross-functional CMC teams to drive strategy alignment on risk mitigation, resource planning, process validation, regulatory filing, and post approval changes.
Strong program management skills with operational experience in tracking multiple activities, deliverables, timelines, contracts and budgets.
In-depth knowledge of CMC quality and regulatory requirements in support of global regulatory filings.
Experience with managing CDMOs.
Demonstrated track record of successful tech transfers to commercial CDMOs.
Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders.
Strong sense of urgency and ability to direct the CMC team towards their deliverables in a highly fast-paced environment.

Nice To Haves

Experience with pre-filled syringe and/or auto-injector is a plus.

Responsibilities

Oversee technical operations and lead strategy discussions for late-stage CMC activities including process characterization, PPQ, licensure application, regulatory inspection, and lifecycle management of monoclonal antibody therapeutics.
Work with internal and CDMO CMC teams to ensure timely delivery of PC & PPQ protocols and reports, in-process-control documents, process validation master plan, and BLA Module 3 sections.
Lead CMC meetings and ensure drug substance, drug product, analytical, clinical supply chain, quality, program management, and regulatory affairs teams are aligned with overall CMC and program strategy.
Maintain an effective action tracker for internal and external CMC deliverables.
Adapt to changing priorities to ensure corporate CMC objectives are at the forefront.
Facilitate problem solving, action planning, and decision making within the CMC team while keeping program level stakeholders informed at regular intervals.
Foster a strong relationship with CDMOs and consultants, ensuring alignment with Oruka strategy and goals.
Liaise with internal and external stakeholders to support timely completion of technical documents, batch records, campaign readiness, lot release, campaign reports, change controls, deviation investigations, and CAPAs.
Partner with CDMO counterparts to oversee all CMC services, ensuring high quality work, timely delivery, and efficient meetings.
Collaborate with manufacturing and clinical supply chain stakeholders to ensure robust clinical supply and distribution plans.
Drive preparation and presentation of CMC content for internal and external meetings, facilitate cross-functional offsite workshops, and help organize business review meetings with CDMOs.
Support the diligence process and contract negotiation with new CDMOs and consultants.
Work with program managers and Finance to track budgets, contracts, and change orders.