Job Description

Location: Remote - Newbury Park, CA

Employment Type: Contingent Worker (Contract, W2)

Contract Length: 12 months (possible extension)

Compensation: $48/$54 per hour (based on experience)

Summary of the Role

Lead technology transfer and new product introduction programs across the drug substance manufacturing network for a big biopharma leader. Oversee cross-functional teams to ensure successful commercialization and reliable delivery of clinical and commercial drug supply. Drive digital innovation and process efficiencies using analytics, automation, and project management tools to support manufacturing execution. Serve as a senior project lead, coordinating complex operations within global networks and external manufacturing partners.

Key Responsibilities

• Lead new product introduction and technology transfer activities for drug substance manufacturing, from development through commercial implementation
• Act as primary program lead across internal teams and external CDMO networks
• Develop and execute comprehensive technology transfer strategies, integrated plans, schedules, and governance frameworks
• Drive project deliverables, ensuring alignment with program milestones, budgets, and objectives
• Facilitate timely issue resolution and decision-making for project schedules
• Simultaneously manage multiple high-priority technology transfer projects
• Build integrated project plans with clear deliverables, dependencies, and risk mitigations
• Provide executive-level status updates on project progress, risks, and resource needs
• Implement digital solutions utilizing data analytics, automation, and reporting tools to enhance transfer and manufacturing performance
• Ensure standardization, automation, compliance, and data governance across all processes

Required Experience & Skills

• At least 2 years of direct experience in peptide drug substance manufacturing
• Strong understanding of cGMP manufacturing and global regulatory requirements
• Proven success leading complex, cross-functional projects involving project schedules, risk registers, executive communications, and external CMOs
• Demonstrated experience managing multiple technology transfers and manufacturing programs simultaneously
• Minimum 2 years using data visualization, project management, and AI-enabled tools

Preferred Qualifications

• Direct experience with peptide manufacturing
• Master's degree or PhD in relevant scientific discipline
• Experience developing dashboards and analytics using Power BI, Tableau, Spotfire, or similar
• Experience implementing digital tools for project management and technology transfer execution
• Experience with data-driven process improvements and operational excellence
• Familiarity with AI-enabled business processes, predictive analytics, and digital manufacturing technologies
• Strong analytical skills and ability to translate data into actionable business decisions
• In-depth technical understanding of pharmaceutical manufacturing, commercialization, and cGMP

Top 3 Must Have Skills

1. Project Management
2. Drug Substance Manufacturing
3. Power BI

Day-to-Day Responsibilities

• Lead complex technology transfer and new product introduction projects within global manufacturing and CDMO networks
• Coordinate communications, strategies, and execution across cross-functional teams
• Develop and implement project strategies, plans, stage-gate deliverables, and governance frameworks
• Build and maintain integrated project plans, status dashboards, and risk registers
• Drive solutions using Power BI, Tableau, Smartsheet, Jira, SAP, Veeva, LIMS, MES, and related platforms
• Facilitate meetings, support timely decision-making, and promote data integrity and compliance

Basic Qualifications

• Doctorate degree and 3 years of experience
• Master's degree and 5 years of experience
• Bachelor's degree and 7 years of experience
• Associates degree and 12 years of experience
• High school diploma / GED and 14 years of experience

This posting is for Contingent Worker, not an FTE