Senior Manager, Biologics Process CMC (External)

The Senior Manager provides technical leadership and support across multiple CMC biologics areas to drive technology transfer, process validation, and manufacturing of biological drug candidates with a focus on Biologics including mAbs, Bi-specifics and Antibody Drug Conjugates (ADCs).

Requirements

• Apply technical knowledge and expertise in biologics process, biologics drug product, and / or bioconjugation, technology transfer and process validation to advance biological drug candidates across the product life cycle
• Support transfer, development and scale-up of biologics process, biologics drug product, and / or bioconjugation from early-stage CMC, into late-stage CMC to enable clinical and commercial production
• Collaborate with internal and external partners in analytical and formulation groups to advance CMC biologics programs
• Deliver technical support to ensure successful clinical manufacturing, and to develop and implement process improvements as programs advance
• Lead and support various elements of phase appropriate CMC development activities, such as risk assessments, control strategy, and process validation
• Analyze, interpret, present and document complex technical information such as development data or manufacturing and testing trends, in support of CMC objectives
• Work with contract development manufacturing organizations (CDMOs) to help define project scope, review proposals, and oversee technical work
• Contribute to CMC regulatory strategies and submissions, and quality documentation
• Contribute to a broad range of technical objectives, such as troubleshooting urgent issues, proactive monitoring, and analysis of ongoing manufacturing/testing, and longer-term development efforts

Benefits

• 401k plan with generous company contributions
• Group medical, dental and vision coverage
• Life and disability insurance
• Flexible spending accounts
• Discretionary annual bonus program
• Sales-based incentive plan (for field sales staff)
• Opportunity to purchase company stock
• Long-term incentives