Senior Manager/Associate Director - Quality Control

Overview

This is a unique opportunity to be directly involved in supporting the development of our lead product as it moves down the pipeline. You would be joining a seasoned QC team and be responsible for leading, overseeing, and managing outsourced analytical operations for development stage and future commercial products. This includes method transfer, method validation, analytical characterization, analytical comparability and regular QC and stability testing activities at Contract Manufacturing Organizations (CMOs).

Responsibilities

• Work closely with internal QC, Analytical Development, and QA resources to lead successful and timely method transfers, method optimizations, method validations and analytical investigations.
• Oversee external QC testing to ensure valid results are generated on schedule for release and stability testing of GMP products, critical raw materials, in-process testing and environmental monitoring support for external manufacturing.
• Manage project specific CMC timelines based on sound business and scientific strategies through effective communication with multiple CMC groups within CMO/CRO organizations.
• Ensure timely delivery of project specific analytical packages supporting CMC regulatory requirements.
• Monitor CMO Control charting and trending of QC method standards, controls, and data
• Responsible for Product trending
• Oversee and facilitate troubleshooting external methods to ensure reliable test results
• Constantly monitor all project specific analytical development and testing activities to meet various CMC deliverables.
• Participate in the auditing and qualification of analytical labs.
• Communicate and present complex scientific information to scientific and non-scientific audiences.
• Organize projects, set relative priorities, and assign resources.
• Participate in CMC due diligence activities

Qualifications

• Bachelor Science degree in Chemistry/Biology or related discipline
• 10 years QC experience in Biotech/Pharma industry.
• Clinical Experience in phase 1,2,3, and commercial
• Experience managing CMOs and CROs
• Knowledge of FDA regulations, European Directives, ICH guidelines, and cGMP regulations
• Must have FDA/regulatory inspection experience.
• Prior experience with biologics products a plus. 
• Strong knowledge of MS Word and Excel
• Strong written and interpersonal communication skills, this position involves a high degree of customer interaction. 
• The ability to work independently and as part of a team
• European or Global experience a plus
• Ability to travel state side 20-25%

Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.