Associate Director, CMC Lead, Late-Stage Biologics

Job Title: Associate Director, CMC Lead, Late-Stage Biologics      

Location: Remote OR Hybrid 3 days/week in office if located near Waltham, MA will be required.         

Role Overview: The Associate Director of CMC Leadership will provide technical and strategic leadership for late-stage CMC activities supporting the development, characterization, validation, licensure application, commercial readiness, and lifecycle management of biologics manufacturing process, with a focus on monoclonal antibodies. This role is a critical addition to our growing organization and is highly visible within the CMC team and across other functions. Serving as a matrix leader, this role will work closely with the CMC function leads in drug substance, drug product, analytical, and clinical supply chain. This role will also partner closely with Program Management, Quality, Regulatory Affairs, CDMOs, and consultants.

The ideal candidate is an established technical and matrix leader with hands-on technical experience in biologics process development and manufacturing support, and proven track record in leading cross-functional teams to achieve complex technical and regulatory milestones and bring late-stage biologics therapeutics to commercialization.

Key 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. Ensure the external partners are fully aligned on 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 service, 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.
• 20-25% travel in support of diligence process, strategy discussion meetings, and activity supervision at CDMOs.

Qualifications:

• 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 preferrable. Have led cross-functional CMC teams to drive strategy alignment on risk mitigation, resource planning, process validation, regulatory filing, and post approval changes.
• Experience with pre-filled syringe and/or auto-injector is a plus.
• 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

Compensation:

• 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.
• The anticipated salary range for candidates, who will work in Waltham, MA -OR-remotely, is $182,000 to $208,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.