Senior Director, Technical Operations

Electra Therapeutics, based in South San Francisco, California, is a clinical stage biotechnology company developing therapies that target signal regulatory proteins (SIRP) for the treatment of immunological diseases and cancer.

We are seeking an accomplished and strategic Senior Director of Technical Operations to lead and oversee external CDMO partnerships for the drug substance manufacturing of monoclonal antibodies (mAbs). This individual will play a critical role in the development and execution of manufacturing strategies across our biologics pipeline, ensuring seamless tech transfer, process robustness, operational excellence, and compliance. The ideal candidate brings deep experience in late-stage biologics manufacturing, commercial readiness, and a proven track record in BLA (Biologics License Application) preparation and submissions.

RESPONSIBILITIES: 

• Serve as the technical and operational lead for drug substance CDMO management, overseeing drug substance development and manufacturing activities across clinical and commercial stages.
• Drive technology transfer and manufacturing site transfer activities from process development to GMP manufacturing at external partners, ensuring scalability, robustness, and compliance.
• Lead drug substance development activities in support of regulatory filings, including INDs, BLAs, and global marketing applications.
• Lead drug substance development activities include site transfers, process characterization and process validation.
• Develop and implement strategic manufacturing plans that align with program timelines and regulatory requirements.
• Establish and monitor performance metrics for CDMOs, including adherence to timelines, quality standards, and cost controls.
• Provide technical oversight during manufacturing campaigns, including support for deviation investigations, CAPAs, and process improvements.
• Collaborate closely with QA, Regulatory Affairs, and Supply Chain to ensure alignment across all functions.
• Serve as a subject matter expert (SME) for drug substance development and manufacturing, contributing to regulatory filings, inspections, and due diligence efforts.
• Maintain current knowledge of regulatory trends and advances in biologics manufacturing to inform strategic decision-making.

QUALIFICATIONS:

• Advanced degree (Ph.D. or M.S.) or equivalent experience in Chemical Engineering, Biochemistry, Biotechnology, or a related field.
• 10+ years of experience in biologics manufacturing, with a strong focus on monoclonal antibodies.
• Demonstrated leadership in managing CDMO relationships and overseeing external manufacturing operations.
• Hands-on experience with tech transfer, GMP manufacturing, and process validation of biologics.
• Proven experience in leading or contributing significantly to BLA submissions and regulatory interactions.
• Deep understanding of FDA, EMA, and ICH regulatory guidelines pertaining to biologics manufacturing.
• Excellent project management, communication, and cross-functional leadership skills.
• Strategic thinker with strong problem-solving capabilities and a collaborative mindset.

PREFERRED QUALIFICATIONS:

• Experience in commercial launch of biologics products.
• Prior experience with global CDMO networks and supply chain strategy.

The salary range for this position is $230,000 - $260,000. Base salary compensation is determined by a range of factors, including but not limited to candidate experience, qualifications, location and more.