Quality Control Manager, Critical Reagents

3 weeks ago

Germantown, United States Novavax Full time

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.

The QC Manager, Critical Reagents is responsible for managing the reference standards and critical reagents in compliance with internal SOPs and ICH guidelines. The Manager, Critical Reagents 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.

This position will report into the Associate Director, Analytical Services and be a part of the Quality Control Extended Leadership team.

**Responsibilities include but are not limited to**:

- Manage and oversee the Critical Reagents and Reference Standards function
- Manage and oversee operational oversight for critical reagent management across the organization working closely with Novavax’s manufacturing network of internal and external testing sites and manufacturing partners (CMOs/CTLs), our colleagues in R&D, Quality, Regulatory, Supply Chain, and Commercial
- Manage and lead the development of robust systems for the selection, qualification, monitoring, tracking, and storage of critical reagents to ensure delivery of quality products to our patients worldwide
- Manage and lead building, developing, and coaching a team that can deliver continued supply of critical reagents and reference standards to both internal Novavax and external testing locations such as CMOs and OTLs
- Manage and oversee development and establish new strategic capabilities for our global inventory management systems at Novavax
- Primary point of contact and owner for management of a robust system for the monitoring, tracking, and storage of critical reagents to ensure quality and commercial supply availability.
- Develop and implement policies, procedures, and training programs to ensure compliance with regulatory requirements and industry best practices
- Oversee and support preparation of regulatory submissions, oversight during inspections and audits, and respond to questions from regulatory bodies within in the scope of critical materials and reference standards
- Collaborate with cross-functional teams to develop risk assessments and mitigation strategies for critical reagents
- Manage inventory, strategic planning, and lifecycle management of reference standards and critical materials

**Minimum Requirements**:

- Bachelor in a Life Sciences discipline or equivalent experience is a minimum requirement plus 10 or more years of relevant experience and at least 5 years of management experience in GMP regulated laboratory preferred.
- Considerable knowledge/expertise relevant to Critical Reagents and Reference Standards Program, including ICH guidelines, QC methods used for protein chemistry, molecular biology and microbiological testing.
- Strong Biostatistics background for evaluating comparability and qualification of new reference standards
- Experience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in a Quality Assurance/QC function with a strong familiarity of general GMP practices.
- Experience in writing SOPs, qualification protocols and reports as well as annual product performance reports.
- Experience with LIMS, Qumas (or similar), and statistical software (.JMP) is preferred.
- Broad experience with biochemistry, biological and microbiological assay support, as well as generating/reviewing the documentation that supports such work.
- Ability to succeed in a team-oriented environment under very dynamic conditions.

**Preferred Qualifications**
- Experience with reference standards and critical reagents qualifications
- Experience working with external suppliers: CMOs/CROs/CTLs
- Experience with analytical statistics and statistical software (.JMP)

Novavax offers a base salary, annual bonus

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