Director, Analytical Sciences at Jobgether – United States

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director, Analytical Sciences in United States.

This role offers a strategic leadership opportunity in biologics analytical development, driving innovation and operational excellence across clinical and late-stage programs. You will oversee method development, validation, transfer, and GMP quality control testing while collaborating closely with global CDMO partners and cross-functional teams. The position requires both technical expertise and strong leadership skills to ensure scientific rigor, regulatory compliance, and timely progression of drug candidates. You will shape analytical control strategies, support regulatory submissions, and implement continuous improvement initiatives to optimize efficiency and quality. This is a highly visible, impactful role where your decisions directly influence program success, product quality, and patient outcomes. The environment is fast-paced, collaborative, and mission-driven, offering broad exposure to cutting-edge biologics development.

• Provide strategic and technical leadership for analytical development and quality control across the biologics portfolio, including method development, validation, transfer, and lifecycle management through CDMO partners.
• Serve as a subject-matter expert for biologics assays and analytical control strategies, supporting regulatory submissions and driving continuous improvement initiatives.
• Lead analytical method transfer, qualification, and validation activities at CDMO laboratories, ensuring protocol and data integrity.
• Ensure all analytical activities comply with FDA, cGMP, ICH, and QbD principles, and align with industry best practices and company quality standards.
• Collaborate with Quality Assurance to maintain analytical quality infrastructure, inspection readiness, and GMP compliance for both internal and external operations.
• Drive proactive planning to support efficient progression of drug candidates and maintain alignment with program timelines.

• Advanced degree in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related discipline.
• 10+ years of biopharma industry experience in analytical development and quality control for protein biologics.
• Proven expertise supporting regulatory submissions (IND, CTA, BLA) with strong understanding of phase-appropriate method development, validation, and analytical control strategies.
• Demonstrated leadership in managing biologics program deliverables in a fast-paced environment.
• Strong communication and cross-functional collaboration skills to influence technical and operational outcomes.
• Experience in mAb or mAb-combination product analysis is a plus.
• Familiarity with small company or start-up environments is advantageous.

• Competitive base salary range of $195,000 to $225,000, with performance bonus opportunities.
• Equity grant opportunities and comprehensive health, welfare, and retirement benefits.
• Unlimited PTO and two one-week company-wide shutdowns per year.
• Professional development opportunities and mentorship programs.
• Remote work flexibility with periodic in-person meetings for collaboration and problem-solving.
• Opportunity to contribute broadly to advancing life-changing medicines in a dynamic, high-impact environment.