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Senior Manager of Microbiology

Newark Metro Area, NJ

Posted: 08/26/2019 Job Type: Scientific Job Number: JN -082019-25502


Prerequisites (As Applicable) BS (higher degree preferred) in a microbiological science.

5+ (Manager) or 8+ (Senior Manager) years of experience in microbiology for compounds in development.


PURPOSE AND SCOPE OF POSITION:

Responsible for establishing microbiological policy requirements, and processes for compounds in development.

Responsible for providing SME oversight and expertise associated with microbiological aspects in testing, manufacturing operations and deviation/investigation resolution for all products.

Is the main contact for regulatory agency inspections (FDA, EMEA, MHRA, etc.) associated with microbiological inquiries for compounds in development.


REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

Must be a technical/scientific expert in microbiology as it relates to pharmaceuticals. Must be able to measure technical/scientific attributes in qualitative ways and drive science-based decisions across the organization.

Minimum 5 years of experience in biological/small molecule product quality assurance and/or manufacturing, with working knowledge microbiology, and virology techniques

Thorough knowledge of cGMP in the pharmaceutical and biologics industries.

Must have expert authorship of technical documents. Must be able to recognize the impact beyond a single project or collaboration.

Must possess a strategic perspective, leading vision and values, global acumen, and leadership disposition.

Knowledge and applicable experience with investigations, change control, SOP review, and approval, contractor management, method validation, process validation, technology transfer, product quality review, complaint handling, and management notification processes.


EDUCATION AND EXPERIENCE

BS (higher degree preferred) in a microbiological science. 5+ (Manager) or 8+ (Senior Manager) years of experience in microbiology for compounds in development.



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