Summary: The Director, Analytical Development & Quality Control is a key position in our growing Technical Ops team. This individual will be responsible for overseeing key deliverables in analytical development such as method development, assay qualification, release/stability, in-process assays, in-use stability methods, quality control, and quality assurance aspects of Spyre’s pre-clinical & clinical biologics product candidates while partnering with other Tech Ops development groups and quality assurance. This individual will deploy strategic approaches to ensure that all analytical development activities and control strategies comply with relevant regulatory standards and contribute to the efficient progression of drug candidates from pre-clinical stages to clinical trials.

Key Responsibilities:• Provides technical leadership for analytical development and quality control aspects in biologics portfolio programs.
• Manages laboratory operations including method development, validation, and transfer.
• Contributes to the quality control oversight for qualification and validation activities including those performed at CDMO laboratories.
• Ensures compliance of analytical work with FDA, cGMPs, ICH guidelines, and follows QBD principles and industry best practices in all analytical and quality control processes.
• Reviews CDMO reports/documents and performs data verification. 
• Partners with Quality Assurance in developing and managing GMP quality systems and compliance infrastructure for the labs.
• Builds and maintains analytical assay performance trending and reference standard programs.
• Serves as a key technical expert in biologics analytical assays and control strategies.
• Authors and reviews regulatory submission documents suitable for submission to US and ex-US health agencies. 
• Drives scientific rigor and creates internal best practices in analytical development and control strategy.
• Engages in continuous improvement initiatives to enhance operational efficiency.
• Other duties as assigned. 

Ideal Candidate:• Advanced degree in Biochemistry, Pharmaceutical Sciences, Analytical Chemistry, or related field.
• Experience in a biotechnology or pharmaceutical company, with 10 years of direct involvement in analytical development and/or quality control of protein biologics.
• Previous experience with quality control oversight for qualification and validation activities including those performed at CDMO laboratories.
• Proven track record in successful drug submissions (IND, CTA, BLA, etc.) and experience in phase-appropriate method development and validation, analytical control strategy and cGMP requirements.
• Strong leadership skills with experience in managing biologics program deliverables.
• Excellent communication skills and the ability to work effectively in a fast-paced environment.
• Experience in a small company or start-up environment is a plus.

What We Offer• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Unlimited PTO
• Two, one-week company-wide shutdowns each year.
• Commitment to provide professional development opportunities.
• Remote working environment with frequent in-person meetings to address complex problems and build relationships.

The expected salary range offer for this role is $195,000 to $230,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.