Sr Manager, Drug Substance External Manufacturing

CK Group are looking for a talented and dynamic Sr Manager to lead external manufacturing activities for our client. Our client are an exciting Boston based Biotech start-up developing novel immunotherapy products.

Location - Waltham. MA

Responsibilities:

• Responsible for managing external aspects of CMC programs from contracting through execution to ensure product manufacturing meets expectations and timelines for drug substance, cell banks, and other projects as appropriate. Maintains timelines and communicates project updates and risks appropriately
• Establish and foster strong collaborations with external manufacturing partners
• Develop manufacturing service agreements in coordination with Legal, Quality, and internal stakeholder groups. Collaborate with representatives from process development, drug product manufacturing, quality assurance, and quality control to ensure external CDMO scope accurately reflects project needs.
• Primary point of contact for planningand day-to-day execution of external manufacturing activities. Provides project management support for external manufacturing activities by facilitating meetings, tracking action items, etc.
• Manage and lead batch record review, investigations,deviations, change controls, and batch disposition process as needed.
• Partner with QA to ensure qualification audits are conducted and appropriate follow-up items are identified. Identify and resolve gaps in documentation, SOPs, etc
• Ensuremanufacturing data is collected, organized and trended – identifies and implements opportunities for improvement
• Author and review technical reports, manufacturing campaign summaries, and relevant sections of regulatory filings, IND/IMPD, BLA, MAA, etc

Qualifications:

• BS/MS in a relevant biotechnology or scientific discipline
• 5+ years experience in biologics process development or manufacturing and a good working knowledge of typical unit operations (e.g, bioreactor operations, chromatography, filtration, etc)
• Experience working with and managing external contract manufacturing organizations (CMO)
• Experience working in regulated cGMP/GxP environment required and strong working knowledge of cGMP/ICH/FDA/EU regulations
• Well organized, proactive approach to solving problems and building relationships
• Ability to work in a fast-paced environment, meet deadlines, and balance multiple priorities. Independently motivated, detail-oriented, and “can-do” attitude.Entitlement to work in the USA is essential. Please quote 53626 in all communications relating to this role.