Project Manager Senior

Location: Remote - Newbury Park, CA

Employment Type: Contingent Worker (Contract, W2)

Contract Length: 12 months (possible extension)

Compensation: $49/$54 per hour (based on experience)

Summary of the Role

Lead complex technology transfer and commercialization programs in peptide drug substance manufacturing with a focus on both operational excellence and digital innovation for a big biopharma leader. Drive cross-functional teams, oversee transfer of manufacturing processes at external sites, and enhance program visibility. Champion data analytics and digital tools to streamline execution and enable proactive risk management.

Key Responsibilities

• Lead technology transfer and new product introduction (NPI) for peptide drug substance manufacturing at CDMOs from development through commercial launch
• Coordinate cross-functional teams including Process Development, Quality, Regulatory, Supply Chain, Validation, Engineering, Procurement, and Contract Manufacturing Organizations
• Develop and execute comprehensive transfer strategies, governance frameworks, and detailed project plans
• Facilitate timely issue resolution, rapid decision-making, and ensure accurate completion of deliverables
• Own and manage deviation investigations, change control records, SICAR, CAPA, CAPA EV, contracts, and site performance metrics
• Establish governance structures, provide executive-level updates, and build/maintain integrated project schedules
• Deploy digital tools, dashboards, KPIs, and reporting platforms (e.g., Power BI, Tableau, SAP, Jira, Veeva, LIMS, MES)
• Drive standardization and automation of technology transfer and governance processes
• Identify and implement operational improvements, best practices, and lessons learned for program success

Required Experience & Skills

• Proven experience in peptide manufacturing and technology transfer within life sciences
• Strong project management skills leading cross-functional, multi-site initiatives
• Demonstrated ability to drive digital transformation, including automation, dashboard development, and risk analytics using tools such as Power BI, Tableau, SAP, Jira, or equivalent
• Experience managing deviations, change controls, and operational/process improvement
• Ability to effectively communicate with executives, technical teams, and external CDMO partners

Preferred Qualifications

• Experience in pharmaceutical manufacturing operations
• Prior background in digital innovation for technology transfer
• Familiarity with data visualization, manufacturing systems, and process analytics platforms

Top 3 Must Have Skills

1. NPI (New Product Introduction)

2. Peptide Manufacturing

3. Digital Strategy

Day-to-Day Responsibilities

• Lead peptide drug substance technology transfers and new launches
• Facilitate cross-functional program execution and ensure milestone adherence
• Handle deviation investigations and change control records
• Develop and maintain executive dashboards, KPIs, and risk reporting
• Oversee procurement, contracts, and continuous improvement initiatives
• Implement best practices and lessons learned across multiple simultaneous projects

Basic Qualifications

• Doctorate degree and 3 years of experience
• Masters degree and 5 years of experience
• Bachelors 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