Report to: Manager Dev QA or Analytical Development
- 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 Company 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.
Duties And Responsibilities
- Establishes and performs and/or manages the following responsibilities associated with laboratory, pre-clinical, and clinical compounds in development:
- Creation of micro specification and test methods for raw materials, in-process controls, and final product.
- Review and approval of micro related investigations, change control, and protocols (methods for release testing, technology transfers, product process, stability, cleaning, and sterilization).
- Management of analytical laboratories conducting micro testing
- Responsible for microbiological aspects for compounds in development:
- Conducts investigations, identifying root cause(s) and corrective/preventive actions.
- Reviews the compliance of microbiological data to the specifications and GMPs as part of data review and trends these data for investigations.
- Reviews method validation reports for accuracy and compliance with protocols and, when necessary, develops method validation protocols and writes summary reports.
- Establishes positive relationships with contract testing laboratories and open lines of communication to promptly resolve issues associated with testing.
- Conducts/assists with periodic audits of contract testing laboratories and investigates microbiological issues at a contract testing laboratories, a manufacturing vendors and/or suppliers.
- Keeps abreast of compendia updates and current regulatory events.
- Review and Approval of microbiology validations for process and laboratory.
- Vendor Contacts: Communicates, when necessary, with manufacturing and service providers regarding microbiological testing, investigations, and deviations.
- Communications: Communicates, works with, and provides timely services to internal colleagues in QA, QC, AR&D, Technical Operations, Information Systems, Metrology, Site Maintenance, and Training groups.
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.
Product Quality Assurance
Medicines And Healthcare Products Regulatory Agency (Mhra) Guides
Based on Job Title, Location and Skills
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