API DS Network Contamination Control Strategy
Overview
The role oversees contamination control strategies across Lilly's API network. It drives harmonization of technical programs and ensures alignment with regulatory and business goals. This position supports both internal sites and external manufacturing partners to maintain robust contamination prevention measures.
What You'll Do12
- 1Develop deep technical understanding of contamination control across diverse API production platforms
- 2Ensure contamination controls match modality-specific risk factors
- 3Influence application of industry and regulatory expectations for contamination control
- 4Provide technical support to new API/DS sites during design and start-up
- 5Support network expansion and site readiness for contamination programs
- 6Lead technical efforts for API external manufacturing and tech transfers
- 7Assist with regulatory submissions and Q&A processes
- 8Oversee contamination control strategy development across product portfolios
- 9Mentor site SMEs to build technical capability
- 10Collaborate with global molecule stewards and cross-functional teams
- 11Perform network investigations to determine root causes and implement corrective actions
- 12Share best practices and CAPAs across sites
Requirements10
- 17+ years' experience in pharmaceutical manufacturing focusing on API synthesis/fermentation/cell culture and purification stages
- 2Deep technical knowledge of contamination control requirements and regulatory expectations
- 3Proficiency in bioburden, endotoxin, and adventitious agent testing procedures
- 4Strong data analysis and problem-solving skills
- 5Experience with cGMPs, quality systems, and regulatory compliance
- 6Ability to travel approximately 25% of time
- 7Additional experience in peptide, oligonucleotide, monoclonal antibody, or ATMP manufacturing
- 8Direct experience supporting regulatory affairs and site quality inspections
- 9Background in CCS oversight, including inspection readiness and CAPA implementation
- 10Education: BS/MS/PhD in biological sciences or engineering discipline
Salary Insight
$129 - $189k per year
Location
Required Skills
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