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
