Manager, Analytical Development

Summary

Join QED Therapeutics, a BridgeBio Pharma affiliate, and contribute to the development of targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. You will be responsible for managing the development and tracking of stage-appropriate testing methodology for drug substance and drug product. This U.S.-based remote role requires quarterly visits to the San Francisco office. The position offers market-leading compensation, comprehensive healthcare, and a hybrid work model with unlimited flexible paid time off. Opportunities for skill development and internal mobility are abundant. The salary range is $130,000-$160,000 USD.

Requirements

• Or MS. in Organic Chemistry, Analytical Chemistry, Pharmaceutical Science
• 5+ years’ experience in the contract research or pharmaceutical/biotech industry
• Demonstrated abilities in the development and application of analytical assay, impurity, and in-vitro (dissolution) release
• Experience in high performance liquid chromatography and physicochemical properties (solubility, solid state, physical testing), methods development, drug substance and drug product
• Knowledge of cGMP regulations, including compendial (USP, EP, JP) and guidance documents

Responsibilities

• Responsible for managing the development and tracking of stage-appropriate testing methodology for drug substance and drug product, including in-process, release, stability, method validation and site transfer under aggressive timelines
• Communicate and coordinate with internal Analytical, CMC, QA, Regulatory, Project Management and consultants, as well as with external CROs/CMOs counterparts
• Manage critical analytical review of SOPs, test methods and specifications for raw materials/intermediates/drug substance/drug product, development/verification reports, validation protocols/reports, method transfers, COAs and stability summaries
• Support contractor site investigations pertaining to OOS/OOT and deviations
• Support Analytical (CMC) activities associated with the reformulation of infigratinib
• Work closely with your Analytical Development colleagues and external CROs/CMOs collaborators to rapidly advance programs to key decision points, in preparation of regulatory submission, approval and post-approval commitments
• Assist in data generation and analysis
• Ensure analytical development activities are aligned with the project’s overall objectives
• Assist in regulatory filings
• Perform data review & stability tracking

Benefits

• Market leading compensation
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals
• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability
• Subsidized lunch via Forkable on days worked from our office
• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
• $130,000 — $160,000 USD