[Hiring] Associate Director/Director Process Chemistry @BridgeBio Pharma

Role Description

The Associate Director, Process Chemistry will be responsible for supporting drug substance related activities, both externally and internally. They will interface directly with CROs, CDMOs and others to execute on-time delivery and ensure phase appropriate process procedures are followed. Internally, they will interface with both CMC and members of other departments to effectively execute their drug substance project needs.

Responsibilities

• Oversee contract development and manufacturing organizations (CDMOs) to Process Chemistry activities for drug substance (DS) with a focus on late stage and validation, working across both International and US based CDMOs.
• Provide on-site technical support at CDMOs on an as-needed basis to oversee various manufacturing/scale-up/validation activities and provide technical expertise to troubleshoot manufacturing/packaging process issues.
• Author and manage request for proposal documents to initiate work at CDMOs.
• Support and author DS content for CMC Regulatory for US and Rest of World with focus on late-stage development and marketing applications.
• Support Quality Assurance audits, on site at CDMOs or remotely, as a technical subject matter expert, as needed.
• Proactively interface effectively with other CMC team members (e.g., Analytical Chemistry, Formulation Development, Quality Assurance, Supply Chain, etc.).
• Regularly and clearly communicate Process Chemistry both verbally and in visual presentation form, efficiently and contextually.

Who You Are

• PhD. in Organic Chemistry from Purdue University.
• 7+ years as a process chemist in industry.
• Experience leading route scouting, process development, scale-up, DOE, process validation, and CMC strategies for small molecule drug substances.
• Additional experience with authoring and reviewing regulatory documents, including INDs, NDAs, MAAs, CBE30, and Type II submissions.

Salary

$177,400 - $205,200 USD

Benefits

• Market-leading compensation.
• 401(k) with employer match.
• Employee Stock Purchase Program (ESPP).
• Pre-tax commuter benefits (transit and parking).
• Referral bonus for hired candidates.
• Subsidized lunch and parking on in-office days.
• 100% employer-paid medical, dental, and vision premiums for you and your dependents.
• Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA).
• Fertility & family-forming benefits.
• Expanded mental health support (therapy and coaching resources).
• Hybrid work model with flexibility.
• Flexible, “take-what-you-need” paid time off and company-paid holidays.
• Comprehensive paid medical and parental leave to care for yourself and your family.
• 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, & BetterUp Coaching.
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities.