Customer Project Leader (CPL)

Job Description

Located at our large molecule headquarters in RTP, North Carolina, the Customer Project Leader will navigate the complex landscape of drug development, specifically focusing on the analytical stages of Large Molecule & Advanced Therapy Medicinal Products (ATMP). The incumbent serves as the main point of contact for customers, overseeing and guiding the entire analytical process, from early development through to regulatory approval and commercialization.

Critical Performance Areas

• Ensure work is executed in compliance with GMP regulatory requirements and SOPs
• Interpret information with a focus on quality using scientifically sound, risk-based approaches
• Work across multiple quality processes within the QMS to support daily operations and ensure delivery of reliable data to clients
• Provide timely and effective communication to impacted stakeholders across different functional areas
• Contribute to continuous improvement of quality and business processes and represent a culture of quality at the site

Essential Job Functions

• Cover all analytical stages during the drug development life cycle for biologics (NBEs, biosimilars, ATMPs)
• Act as point of contact for customers for all analytical aspects of their project
• Plan and execute projects in alignment with customer expectations, ensuring all requirements are met while managing scope, quality, time, and cost effectively
• Lead cross-functional teams in a matrix setting
• Overlook compilation and review of analytical documentation
• Perform risk analysis and contingency planning
• Initiate and support troubleshooting activities
• Assist the sales team in preparing offers

Requirements

• University degree (analytical chemistry, biochemistry, biology, pharmacy)
• Practical and theoretical knowledge about the analytical development process of biologics: method development, qualification and validation, method transfer, release and stability studies, etc.
• Experience with common protein analytics (e.g. HPLC, spectroscopy, cell-based potency assays)
• GMP knowledge
• Project management experience
• Solid communication skills

Other Desired Skills/Abilities

• Experience with quality management systems and LIMS (e.g., Labware) IT systems
• Ability to adapt to changing project requirements
• Experience leading cross-functional team
• Excellent organizational skills and ability to work and make sound quality decisions independently and quickly
• Strong written and verbal communication skills

This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.

Disclaimer: Solvias US does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.

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