Associate Director/Director, Regulatory Project Management
BridgeBio
Spring
Senior Scientist/Associate Director, Drug Substance Development and Manufacturing
BridgeBio
full-time
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $160,000 - $200,000 per year
Job Level
Senior
Tech Stack
Spring
About the role
- Manage multiple CMOs and CROs to deliver bulk starting materials, intermediates, and drug substance of sufficient quality and quantity to meet corporate and regulatory requirements
- Establish and maintain business relationships with CROs and CMOs for process validation and commercial supply requirements
- Lead late-stage drug substance process finalization, validation, and commercial-scale manufacturing
- Identify and lead key process problem resolution activities and process improvement initiatives
- Work closely with Quality Assurance to develop and operate appropriate CMC procedures and ensure product meets established quality standards
- Create and disseminate technical transfer information required by CROs and CMOs to develop and scale up chemical processes and develop and validate analytical methods
- Support authorship, review, and response to queries on all Module 3 drug substance development sections of CTD and contribute to regulatory control strategy
- Support a culture of continuous improvement and high-performance teamwork
Requirements
- Minimum of a PhD (ideally chemistry or chemical engineering) with 7+ years relevant experience, or a BS/MS with 10+ years relevant experience
- Demonstrated chemistry development at an industrial scale
- Demonstrated experience in managing drug substance chemical development, process validation, and manufacturing in support of marketing applications and commercial production
- Strong aptitude and demonstrated experience in synthetic organic chemistry
- Working knowledge of analytical method development and validation
- Familiarity with FDA and ICH guidelines for INDs/NDAs/MAAs
- Thorough understanding of cGMP, quality, and regulatory requirements for drug substance manufacturing
- Ability to effectively interface with and/or manage highly skilled internal staff
- Ability to work independently and in a team
- Ability to build good work relationships
- Strong attention to detail and time management skills
- Excellent oral and written communication skills
- Up to 20% travel may be required
