Microbiology SME/Manager/Senior Manager
Newark Metro Area, NJ
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.
WORKING CONDITIONS: (US Only)
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
Travel Time: As required