Oversee team of QC Raw Materials and QC Microbiology. Required Knowledge, Skills, and Abilities. Knowledgeable in FDA regulations regarding the manufacturing of biologicals. Good aseptic technique is essential for this position. Environmental Monitoring and QC Raw Material experience required. Individual must be quick to identify and resolve gaps that are identified during day to day. Proficient in Windows based software including Excel and Word. Good communications skills and conversant in comp... more details
If you find science, speed, and helping address serious infectious diseases exhilarating, you have come to the right place.
Individually, we’re skilled, driven, and confident risk-takers. Collectively we're collaborative and accomplished. We're SuperNovas! Together we use our unique experiences, cultures, and learnings to turn innovation into reality while maintaining the highest standards. We value balance, encourage growth, and recognize that you are our most important asset. Build your future with us while bringing innovative vaccines to the world. We have a place for you!
Novavax, Inc (Nasdaq:NVAX) is a biotechnology committed to helping address serious infectious diseases globally through the discovery, development and delivery of innovative vaccines to patients around the world. We have more than a decade of experience contending with some of the world’s most devastating diseases, and we are here to make a difference. Hard-won lessons and significant advances illustrate that our proven technology based on solid science tested by decades of research, has tremendous potential to make a substantial contribution to public health worldwide.
Job Summary
The Senior Manager, QC Microbiology is responsible for managing the quality testing in compliance with internal SOPs and ICH guidelines. The Senior Manager, QC Microbiology must demonstrate strong leadership, as well as statistical and technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to quality, compliance, and scientific excellence.
Essential Functions
Responsible for overseeing and managing the global raw material program in partnership with Analytical Development, including managing specifications, handling changes as well as implementing new raw materials and consumables as part of tech transfer activities.
Direct management and supervision of the Novavax Gaithersburg QC Raw Materials team performing raw material testing according to USP/EP/JP guideline and releasing raw materials for use in the manufacturing processes.
Responsible for testing, disposition, and release of raw materials and the timely investigation of deviations including Out of Specification (OOS) results.
Provide managerial support for troubleshooting of complex investigations and optimizing laboratory systems.
Manages the QC Raw Materials team in support of production by ensuring the timely release of raw materials.
Serves as the technical subject matter expert (SME) on raw material specifications, microbiological assays and techniques.
Responsible for overseeing the Novavax Gaithersburg QC Microbiology team in support of production in the timely environmental and utility monitoring of the facility and systems.
Oversee the receipt, distribution, tracking and coordination of QC Micro and QC Raw Material cGMP samples for testing.
Assist in the authoring, review, approval and execution of QC SOPs and protocols, and writing or editing assay verification protocols as needed.
Works to assist Microbiology staff on Microbiology related deviations, CAPA, and OOS investigations.
Represents the QC Raw Materials and QC Micro teams in meetings with Production, Quality Assurance, and other related departments.
Responsible for the scientific and managerial training for the staff to ensure a competent, professional, and committed microbiology team. Recommends promotions and salary increases as needed.
Oversee data generated by the QC teams and ensure timely completion of trending data reports per required frequency.
Ensures all documentation is in accordance with GMP and all reported results are accurate.
Ensure that suitable written records and work undertaken are kept in accord with cGMP and company procedures.
Assist in maintaining accurate lab inventories and will be responsible for ordering supplies as needed in the lab.
Assist in the maintenance of the lab, which includes routine housekeeping activities.
Identify and troubleshoot equipment and software problems.
Represents the QC Raw Materials and QC Micro team during internal or external regulatory and customer audits.
Contribute to team building, training, and problem-solving initiatives internally and cross site.
Keeps accurate testing records and assures that laboratory equipment has been calibrated, standardized, and monitored as appropriate.
Assists in the writing, reviewing, and editing of standard operating procedures, laboratory protocols, and reports.
Evaluate new Microbiology methods and equipment.
Supervisory Responsibilities
- Oversee team of QC Raw Materials and QC Microbiology
Required Knowledge, Skills, and Abilities
Knowledgeable in FDA regulations regarding the manufacturing of biologicals.
Good aseptic technique is essential for this position.
Environmental Monitoring and QC Raw Material experience required.
Individual must be quick to identify and resolve gaps that are identified during day to day.
Proficient in Windows based software including Excel and Word.
Good communications skills and conversant in computer systems.
Excellent multi-tasking and organizational skills.
Working knowledge of LIMS preferred
Education, Experience, Licenses & Certifications
Bachelor’s degree in biological science. Microbiology experience preferred.
3-5 years of direct supervisory or management experience.
Minimum 8 years’ experience in a cGMP laboratory, preferably related to pharmaceutical industry operations.
Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.
Equal Opportunity Employer/Veterans/Disabled
Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.
Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.
