KBI
Senior Director, MS&T
USA - NC - Durham - National Way · Director
Sponsorship not specifiedDetected 1 day ago
Supply ChainGMPCommunicationCollaboration
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16Unrated
Cap-exempt (no lottery)0
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Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- The Director or Senior Director should demonstrate proven technical expertise in upstream or downstream biologics and have strong knowledge of industry best practices.
- Establish plans and strategies to ensure successful cGMP production by actively collaborating with manufacturing operations, quality and supply chain
- Recruit and retain talent within organization.
Responsibilities
- Leads multi-disciplinary cross-functional projects
- Oversees and maintains the procedures, business processes and tools for downstream tech transfer.
- Drive new commercial product introduction and process validation from Stage 2 PPQ through Stage 3 CPV Process Validation and Pre-Approval Inspection (PAI)
- Drive new clinical product introduction to ensure successful tech transfer through collaboration with Process Development
- Drive standards and industry best practices to ensure organizational efforts are scalable and sustainable across sites
- Drive activities of department resources to facilitate revenue growth and risk mitigation for manufacturing organization.
Requirements
- BS in Science or Engineering with minimum of 18 years industry experience, Masters with 16 years industry experience or PhD with 14 years industry experience.
- Must have demonstrated biologics expertise in upstream or downstream processing and operations
- Must have experience in collaborating with process development, quality, supply chain, engineering and manufacturing.
- Demonstrated expertise in technical transfer, process validation, process engineering and optimization/scale up of biological processes is required
- Experience with cGMP production operations is required
Nice to have
- Experience working in a cGMP manufacturing environment is a plus
Benefits
- Represent the department during audits, client meetings and multi-disciplinary meetings with boards of health and upper management.
- Represents department in various technical and projects team meetings with client, board of health and upper management.
Company info
- I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me.
This listing is sourced directly from KBI's careers page and normalized into a canonical job model.