Vera Therapeutics, Inc. · 1 month ago
Senior Manager, Commercial Packaging
Brisbane, CA
Full-time
Onsite
Senior Level
$123K/yr - $186K/yr
5+ years expVera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. The Senior Manager, Commercial Packaging will oversee all aspects of Finished Goods packaging operations and transport engineering, ensuring compliance with cGMP regulations while managing relationships with Contract Manufacturing Organizations.
BiotechnologyHealth Care
Responsibilities
Direct day-to-day external (CMO) packaging operations, including projection of material requirements, budgets, and timelines
Manage technical oversight and guidance to CMOs for packaging technology transfers, optimization, and cGMP packaging of biologics drug product in support commercial supply
Act as subject matter expert and project manager for packaging process validation, shipping distribution validation both in real-world and laboratory simulation environments
Manage the transport qualification of temperature controlled shipment of goods across the end-to-end supply chain
Oversee and manage the operation and configuration of Level 4 Track-and-Trace systems. Understand market and regulatory requirements from FDA, EMA and other global jurisdictions
Manage the creation, update and obsoletion of printed components artwork partnering with Regulatory, Marketing, CMOs and third party printer/converters
Execute plans in accordance with cGMP, ICH, and FDA regulations
Write, update and review relevant sections for regulatory submissions
Partner with and maintain regular contact with key stakeholders including Drug Product, Analytical Sciences, Quality Assurance, Regulatory Affairs, Finance, and Program Management
Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents
Qualification
Required
MS in relevant life sciences or M Eng. in relevant engineering discipline preferred with a minimum of 5 years of Pharmaceutical/Biotechnology industry experience in cGMP manufacturing operations of biologics, or BS in relevant life sciences or engineering discipline with a minimum of 8 years of Pharmaceutical/Biotechnology industry experience in cGMP manufacturing operations of biologics
Experience in managing US/international CDMOs for the packaging of cGMP drug product is required
Knowledge of global serialization and track-and-trace processes is required
Experience validating and overseeing temperature controlled global transportation lanes
Familiarity with packaging standards (ASTM, ISTA, ISO), container closure integrity (CCI), and stability testing protocols
Working knowledge of FDA and international cGMP regulatory guidelines and submissions
Proven leadership and cross-functional management of CMC-related programs
Critical thinking and problem-solving skills with ability to drive risk-based decision making
Strong organizational and project management skills, including proficient use of MS Project and other tools
Excellent communication and interpersonal skills in working across the organization
Preferred
Experience in commercial rapid-launch scenarios is desirable
Certification or previous experience with TraceLink systems is preferred
Company
Vera Therapeutics, Inc.
Vera Therapeutics, Inc.
201-500 employees
H1B Sponsorship
Vera Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (2)
Funding
Current Stage
Public CompanyTotal Funding
$1.23BKey Investors
Oxford Finance LLCAbingworth
2025-12-09Post Ipo Equity· $261M
2025-06-03Post Ipo Debt· $75M
2024-10-28Post Ipo Equity· $300M
Leadership Team
David L. Johnson
Chief Operating Officer
Kerry Cooper
Senior Vice President Medical Affairs
Recent News
2026-01-11
The Motley Fool
2026-01-08
Company data provided by crunchbase