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