Manager, Global Qc, Sterility Assurance
vor 2 Monaten
**The Role**:
Reporting to the Associate Director, Global Sterility Assurance, the Manager, Sterility Assurance, will be collaborating closely with Moderna’s network of Microbiological Laboratories, internal and external (affiliated Contract Testing Organizations (CTOs)/Contract Manufacturing Organization (CMOs)), providing support about the main following topics (not exhaustive):
sterility assurance policies, standards and procedures, validation strategy design;
harmonization/optimization of multi-site microbiological processes (e.g. sterilization, aseptic processing, cleanliness zoning, effective bioburden/microbial control strategies/risk assessments, environmental monitoring program, microbiological testing programs for QC raw materials, intermediate products, drug substances and finished products) for Moderna’s products, produced at Moderna’s manufacturing facility and at affiliated contract organization facilities;
investigations about microbiological deviations in manufacturing and/or in laboratory;
laboratory out of trend (OOT) and out of specification (OOS) investigations.
This position is expected to work in a highly collaborative and cross-functional team environment (including Technical Development groups) also supporting sites in regulatory and third party/HA inspections.
The individual will also act as interdepartmental liaison to various groups including Manufacturing, Quality Assurance, Regulatory and Technical Development. This position may be based both in Moderna US and/or in Moderna International organizations.
**Here’s What You’ll Do**:
Ensure continuous support in setting policies/standards/procedures and support related implementation
Ensure cGMP compliance with global regulations in the context of microbiological sterility assurance processes.
Facilitate harmonization/optimization of multi-site microbiological processes and systems (e.g. sterilization, aseptic processing, cleanliness zoning, effective bioburden/microbial control strategies/risk assessments, environmental monitoring program, microbiological testing of QC raw materials, intermediate products, drug substances and finished products, technology transfer and method validation, critical reagents program).
Providing input in the design of manufacturing processes, controlled environments, and packaging from a microbiological standpoint: Conduct risk assessments, as needed, to ensure compliance.
Act as sterility assurance contamination control SME
Assure the harmonization of low bioburden policy and strategy.
Establish and maintain the company contamination control strategies and related documents.
Perform all investigations related to microbial control for facility and DS/DP products (endotoxin / bioburden)
Own gowning, cleaning, wipe down processes working collaboratively with MFG to reset baseline.
Facilitate and drive the EAT
Draft and summarize the facility trend reports.
Build out team to incorporate specialists with required skills to advance program: Trending, MFG process knowledge, MODA report overhaul.
Take ownership of gowning qualifications and program.
Generate technical reports, as required, to support business needs to include product impact statements where microbial control is challenged.
Draft and establish and maintain VAL-RA documents for EM Site selection
Function as central services for facility in terms of contamination control.
Provide technical support, in the context of microbiological processes:
for sites and product related inspections (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP inspections);
to manufacturing and quality during manufacturing and/or laboratory deviation investigations, change control and CAPAs.
Work with Digital/IT to continually strengthen data integrity across microbiological laboratories world-wide.
Support Annual Product Quality Review (APQR) activities.
Participates in Specification Review Committee in establishing and revising microbiological specifications for Moderna’s products to ensure global consistency and alignment.
**Here’s What You’ll Bring to the Table**:
Bachelor’s degree with a minimum of 5-7 years of experience in the biotechnology or pharmaceutical industries, with 3+ years’ experience leading Quality Control/Microbiological Labs in a cGMP organization, with focus in Microbiology. Advanced degree preferred.
Deep understanding and experience with EU and US regulations and ICH guidelines and regulations.
Good knowledge and expertise in microbiological analytical method lifecycle management.
Experience in sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for pharmaceutical manufacturing facilities.
Competency in multiple industrial terminal sterilization methods (e.g., EO, gamma, electron beam, moist heat, dry heat).
Experience with conducting technical/risk assessments of in-house and contract sterilization processes or contract microbiological laboratories (preferre
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