Analytical Development – Manager/Sr. Manager
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Job Description
Senior Manager of Analytical Development at BridgeBio Pharma overseeing QC activities and regulatory compliance. Responsible for managing analytical documentation and coordinating with CDMOs.
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
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%
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
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