Senior Director, Quality Control & Analytical Development

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 a highly skilled and experienced Senior Director of Quality Control and Analytical Development to lead our efforts for our monoclonal antibody (mAb) products. In this role, you will be responsible for overseeing the outsourced testing processes with our GMP service providers. You will ensure that all quality and analytical development activities are conducted in accordance with industry standards, regulatory requirements, and company specifications, ensuring the successful and timely delivery of high-quality biologic products.
 
 
RESPONSIBILITIES: 

• Outsourcing Management: Oversee the relationships with third-party contract testing laboratories (CROs), ensuring that GMP compliance and quality standards are maintained throughout the product lifecycle.

• Quality Control Oversight: Provide leadership and strategic direction to the outsourced quality control function, ensuring appropriate testing methods, analytical technologies, and compliance with regulatory requirements (e.g., FDA, EMA, ICH, etc.) for monoclonal antibodies.

• Analytical Development Leadership: Guide the development and validation of analytical testing strategies for monoclonal antibodies, ensuring robust, reliable, and reproducible testing methods that meet regulatory expectations.

• Regulatory Compliance: Ensure that all outsourced manufacturing, testing, and analytical development activities comply with current GMP standards, regulatory guidelines, and internal company policies.

• Cross-functional Collaboration: Work closely with internal teams, including R&D, Regulatory Affairs, and Supply Chain, to ensure alignment with product development and commercialization timelines.

• Risk Management: Proactively identify and manage risks related to quality control, analytical testing, and regulatory compliance. Develop and implement mitigation strategies to ensure product integrity and quality.

• Documentation & Reporting: Oversee the preparation, review, and submission of quality-related documentation for regulatory submissions for QC testing and stability. Ensuring all documentation is complete, accurate, and in compliance with applicable standards.

• Analytical Comparability: Lead analytical comparability testing for manufacturing and testing site changes.

EDUCATION & PROFESSIONAL EXPERIENCE:

• Education: Advanced degree (PhD, MSc) in Life Sciences, Biochemistry, Chemistry, or a related field.

• Experience: Minimum of 12 years of experience in quality control, analytical development, or related fields within the biologics/pharmaceutical industry, with at least 7 years in a leadership role managing outsourced services.

• Expertise: Strong understanding of GMP, and regulatory requirements for monoclonal antibodies, including experience in analytical testing techniques such as ELISA, HPLC, SDS-PAGE, and other bioanalytical methods.

• Vendor Management: Demonstrated experience managing outsourced testing relationships with contract organizations.

• Leadership: Proven ability to lead and motivate cross-functional teams, both internally and with external partners, to meet aggressive project timelines and achieve quality objectives.

• Communication: Exceptional communication skills, with the ability to present complex technical information to both internal stakeholders and external regulatory bodies.

• Problem-Solving: Strong analytical and problem-solving skills, with the ability to identify issues, develop solutions, and drive resolutions in collaboration with external partners.

PREFERRED QUALIFICATIONS:

• Experience with monoclonal antibody testing across various stages of development (clinical through commercial).
• Experience with late-stage tech/site transfers and comparability studies. 
• Experience in the preparation, authorization, and submission of regulatory filings (BLA) for biologics.
• Familiarity with the latest innovations and technologies in biology, quality control and analytical testing.

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.