BridgeBio

Senior Manager, CMC Analytical Development

BridgeBio

full-time

Posted on:

Location Type: Remote

Location: California • United States

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Salary

💰 $148,800 - $177,400 per year

Job Level

Senior

About the role

  • 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
  • Health insurance
  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
analytical developmentquality controlGMP stability studiesanalytical methods developmentmethod validationHPLCLC/MSGCUV/Vis spectroscopyphase appropriate analytical method validation
Soft Skills
leadershipcommunicationproject managementdecision makingadaptabilityprioritization