Analytical Development – Manager/Sr. Manager

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $163.8k - $177.4k / year

⏰ Full Time

🟠 Senior

👔 Manager

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BridgeBio

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

BridgeBio is a biotechnology company focused on designing transformative medicines for patients with genetic diseases. It employs a novel approach to drug development by integrating finance with science to deliver solutions as efficiently as possible. The company is committed to developing not only life-changing drugs but also leaders in the field, encouraging hands-on engagement and the pursuit of innovation. BridgeBio actively seeks investment to help achieve its mission of providing solutions for unique patient populations with unmet needs. Headquartered in Palo Alto, CA, BridgeBio emphasizes bridging the gap between scientific advancements and patient care.

📋 Description

• 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