Senior Manager, CMC Analytical Development

BridgeBio Pharma

9h•Hybrid

About The Position

The Senior Manager of Analytical Development will join the Analytical Development Team within Chemistry and Manufacturing and Controls (CMC) and report to a Director of Analytical Development. This role will work closely with the entire CMC team to execute late-stage development activities in support of Phase III clinical trials through commercial activities. Candidates for this position will be required to work independently and have experience managing outsourced analytical activities at contract manufacturing sites and testing labs

Requirements

At least 7 years of experience in analytical development in a pharmaceutical setting
Proven leadership experience in managing analytical chemists at various levels externally (CMO mgmt.)
Independently proficient in a variety of analytical techniques and regulatory areas including, but not limited to HPLC, LC/MS, GC, GC/MS, USP dissolution testing apparatus, pH meters, UV/Vis spectroscopy, KF, and phase appropriate analytical method validation
Knowledge and direct experience with CMC analytical regulatory requirements and authoring of IND/IMPD filings and response to regulatory inquiries; experience applying regulatory guidelines (ICH, FDA, EMA, etc.) to pharmaceutical development and CMC strategy
Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates. Ability to understand project timelines and appropriately prioritize activities to achieve project goals
The position will require an ability to adapt to changes in priorities on short notice and will also need an ability to make decisions, independently, under tight timelines
Travel up to 20%

Responsibilities

Oversee contract development and manufacturing organizations (CDMOs) to manage analytical development and quality control (QC) activities for drug substance (DS) and product (DP)
Manage analytical documentation (i.e., CofAs, test methods, protocols, reports, specifications, stability, and raw data) within Quality Management System (QMS)
Support and author analytical content for CMC Regulatory content for U.S. and Rest of World dossiers
Manage GMP stability studies and provide trend analysis in support of retest and shelf-life extension
Manage reference standard program (i.e., qualification, storage, inventory, distribution)
Development and approval of specifications for raw materials, intermediates, and finished product and knowledge of regulatory requirements in the setting of specifications
Development and validation of analytical methods and verification of compendial methods
Able to communicate results both internally and externally through oral and written updates and formal reports as necessary
Provide analytical support for API and Drug Product process development
Authoring of development reports, protocols, and methods
Support quality audits as a technical representative and contribute to authoring of audit reports

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