Novavax, Inc.(Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.Novavaxrecently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, and achieved positive Phase 1 clinical trial results. NanoFlu, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies.Novavaxis a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.
We are seeking a Director to lead our Downstream Development department. The qualified individual will be responsible for leading and building a team of scientists/engineering to develop, optimize, and characterize the validatable purification processes for Phase I through Phase III clinical development as well as support of licensure and commercial product. The candidate will also be responsible for managing and facilitating technology to the Manufacturing Group and external partners. Other responsibilities include supporting product characterization, ensuring material supplies for formulation and assay development, providing critical reagents and developing/implementing new technologies. The applicant will prepare CMC sections of regulatory documents along with supporting documentation. The successful candidate will formulate the overall strategy for downstream process development and will collaborate effectively with other Development groups as well as with Discovery, Regulatory, Clinical and Manufacturing Departments. The candidate will be expected to take an active role in the professional development of direct reports.
The position will be located at our Gaithersburg, MD facility and report to the Vice President of Process Development.
Responsibilities include but are not limited to:
- Lead a group responsible for the development of consistent, high-yielding, high-purity, scalable, validatable, and economical downstream purification
- Demonstrate sound scientific and technical understanding when optimizing a process
- Identify, apply, and develop new technologies to advance purification capabilities
- Design, in conjunction with staff, well-thought out experiments using a Design of Experiments (DOE) approach incorporating QbD into the process characterization
- Assist in scale up, characterization, and optimization of all programs. Provide support for critical operations as needed in our GMP manufacturing facility
- Responsible for supporting and/or leading process validation activities and strategies including evaluating downstream process characterization plans from process validation protocol creation to report writing
- Responsible for project coordination and resource management including identification of personnel hiring requirements and skill set gap analysis
- Participate in tech transfer to other groups and external partners
- Thoroughly analyze results and methods, troubleshoot processes, generate solutions to problems, and meet regulatory expectations for process development
- Manage direct reports including Scientists and Engineers at the BS, MS, and PhD levels
- Manage work assignments for "indirect" report technical staff at our joint venture partner (CPLB) in India
- Maintain effective communication within process development including cell culture, formulation and analytical as well as QC, Discovery, and clinical functions
- Prepare and review process development reports, protocols and reports, CMC regulatory filings, and scientific journal publications and presentations
- Prepare and present finding to Novavax partners and collaborators
- BS, MS or Ph.D. in Engineering, chemistry or biological science with commensurate years of experience. For example, PhD with at least 8 years' experience in pharmaceutical, biologics, and/or vaccine product development is expected at the Director level
- Strong expertise in process design and development of downstream unit operations with a thorough understanding of chromatography separation and viral inactivation. Experience with products requiring cell lysis, a strong plus
- Demonstrated ability to improve product purity and yield with economically viable process choices
- Ability to manage a team of scientists/engineers, and develop and motivate team to achieve results
- Ability to define priorities and process to get things done
- Ability to work effectively with cross-functional groups. Experienced in process tech transfer
- Ability to critically review data and technical reports
- Strong understanding of FDA regulatory requirements associated with process characterization and documentation of vaccine products
- Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs)
- Present scientific findings at internal and external meetings
- Other knowledge and competence:
- Strong people management experience, including leading staff at the various levels
- Experience in leading managing a laboratory
- Demonstrated teamwork, organizational, and leadership skills
- Proven ability to influence across functions and organizations
Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.
Novavax, Inc. offers a base salary, annual bonus, stock options, 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, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.Job Posted by ApplicantPro