Associate Director/Director, Analytical Development

BridgeBio Pharma

6h•Remote

About The Position

In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work. We are looking for an experienced Analytical Associate Director/Director to join our expanding CMC team. This position works directly with the Senior Director of Analytical Development, CMC and manages an analytical team that oversees multiple CDMOs analytical development and quality control activities. If you have a complete understanding of GMP requirements and experience working on various drug development phases, we would love to hear from you!

Requirements

Degree (BS or MS) with 7+ years of relevant analytical chemistry experience. PhD preferred
Oversite of external QC laboratories (e.g., method development, method validation & troubleshooting analytical procedures)
Experience with stability and shelf-life management
Practical working knowledge of ICH guidance
Knowledge of small molecule chemical characterization techniques
Broad understanding of analytical techniques, with a focus on (U)HPLC
Hands-on GMP experience with all phases of drug development including experiencing authoring IND/IMPD and marketing applications, as well as in-depth knowledge and complete understanding of GMP requirements
Ability to critically evaluate and troubleshoot complex problems while offering timely and informed options for resolution
Strong verbal & written communication skills, with the ability to effectively interact with and influence different functional groups across all levels of management
Position requires up to 20% travel
Strong focus on quality and attention to detail
You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies

Responsibilities

Oversee both international and US based contract development and manufacturing organizations (CDMOs) to manage analytical development and quality control (QC) activities for our drug substance (DS) and drug product (DP) suppliers
Lead, coach and develop a team of direct reports, fostering a high-performance growth-oriented culture
Manage DS and DP stability programs and corresponding shelf-life determinations
Regularly and clearly communicate Analytical Development and QC topics both verbally and in visual presentation form, efficiently and contextually
Support and author analytical content for CMC Regulatory for US and Rest of World dossiers
Support Quality Assurance audits, as a QC subject matter expert, as needed
Provide on-site technical support on an as-needed basis to oversee various manufacturing/scale-up/validation activities
Proactively interface effectively with other CMC team members (e.g. Process Chemistry, Formulation Development, Quality Assurance, Supply Chain, etc.)

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