If you find science, speed, and success exhilarating, you have come to the right place.
Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases. We have more than a decade of experience contending with some of the world’s most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.
Our scientists are committed to developing vaccine candidates for some of the world’s toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.
Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.
Summary of the Position:
We are seeking a Senior Bioengineer, MS&T Technical Services who will support drug substance CMC-related activities across the Novavax product portfolio, including tech transfer, manufacturing, and supply of clinical and commercial drug substance (DS). The ideal candidate will be a highly motivated individual with experience and interest in working in a growing entrepreneurial environment with broad responsibilities and opportunities. Partnerships with global DS manufacturing at sites outside the US will/may require significant travel. The candidate will collaborate internationally, offering visibility and opportunity to directly contribute to the company's success. This role will be critical in ensuring establishment of robust operations and governance across multiple CMC functions to meet critical deliverables.
**Must be flexible and open to significant domestic or international travel, as well as shifted work hours to cover communication with international Manufacturing Sites**
Responsibilities include, but not limited to:
- Responsible for providing drug substance manufacturing support for clinical development through commercial supply.
- Provide MS&T presence at manufacturing sites as required to support global activities and specifically to deliver robust, scalable and cost-effective manufacturing processes that meet or exceed the target quality product profile.
- Builds and manages technical relations at manufacturing sites to ensure that operational and technology transfer activities are performed consistently, completely and compliantly.
- Engage cross functional collaboration with Quality Control and Quality Assurance to ensure that manufacturing sites are applying systems and processes in compliance with Corporate Quality systems and all relevant regulatory standards.
- Support all elements of manufacturing site planning processes, production scheduling, manufacturing processes to deliver DS supplies on time in full.
- Review and/or approve tech transfer protocol/reports, manufacturing batch records and Quality Notifications.
- Facilitates communication between Manufacturing site and global resource as needed for production support.
- Collaborates with Supply Chain to ensure Bill of Materials are routinely updated and forecasted for critical material supplies.
- Review and report process performance based on Key Performance Indicators and CPV (as appropriate).
- Review and approve process comparability or quality risk assessment documents during transfer and process validation; provide input to control strategy based on site specific requirements.
- Work with technical SME to oversee execution of the validation of DS processes as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations.
- Assist with preparation of CMC modules in support of regulatory submissions.
- May provide hands-on technical/team support for technology transfer, and qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates e.g. media, buffers and cleaning solutions.
- Collaborate with Quality and other CMC team members to ensure consistent application of Quality governance and performance review.
- Significant travel required, both domestic and international (up to 50%).
- MS or BS in engineering, chemistry, biology, or related discipline.
- BS with 6+ years or MS with 4+ years of experience in pharmaceutical or biological operations focused on late phase process transfer, pre-approval inspection, and clinical/commercial manufacturing
- Knowledge of CMC development from clinical through commercialization
- Strong understanding of FDA/EMA/MHRA regulatory requirements associated with manufacturing of vaccine products.
- Experience in oversight or implementation of technology transfer, process optimization, characterization, and/or commercial operations is beneficial.
- Diverse knowledge and experience in various relevant areas, including but not limited to molecular/cell biology, protein production, harvest, downstream purification and common analytical tools is preferred.
- Strong project management and change management skills. Excellent record keeping abilities to adequately record, analyze and document data generated in support of regulatory requirements.
- Strong interpersonal and communication skills with proven cross-functional collaboration experience in a technical environment
- Capable of performing multiple functions in a fast-paced environment. Strong technical writing and good organization skills are required.
- Demonstrated verbal and written skills in communicating scientific and technical information.
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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)