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Director, Manufacturing Science & Technology

Company: Novavax
Location: Gaithersburg
Posted on: September 17, 2020

Job Description:

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.  Novavax  recently 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.  Novavax  is 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 currently building worldwide manufacturing capacity for our COVID-19 vaccine, to allow for rapid scaling of production capacity in our goal of delivering 1-2 billion doses of vaccine in 2021. In parallel with that work, we are moving our NanoFlu vaccine program forward towards PPQ and licensure as well as preparing for future internal pandemic response vaccine capability. To assist with these programs, we are seeking a Director of Manufacturing Science & Technology (MS&T) to coordinate technical oversight of manufacturing and process validation. Responsibilities include technical support of internal and external manufacturing, PPQ execution, process trending and analysis, and oversight of process change/comparability. The ideal candidate will be a highly motivated and flexible individual with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.

*Flexible on level to Associate Director/Sr. Director based on candidate's qualifications

Responsibilities include but are not limited to:

Accountability over investigation and troubleshooting of drug substance (DS) processes being operated at internal and external manufacturing.

Partnership with Process Development and Analytical Development teams to guide generation of data, analytics, and process controls that meet operational needs.

Partnership with Process Development and Analytical Development to generate stage 1 process validation deliverables, such as QTPP, process control strategy, and early process risk assessments.

Partnership with Validation and external CMO organizations to generate and execute stage 2 process validation deliverables, such as PPQ protocols and testing plans.

Accountability for continued process verification , including process monitoring programs across multiple manufacturing programs and manufacturing sites.

Accountable for technical oversight of supplier initiated changes and DS process changes.

Contribute to the writing and reviewing of documents for INDs and regulatory section submissions.

Collaborate with other CMC team members to build and execute the CMC development plan.

Lead and develop a team of technical personnel.

Manage expat team in overall support of and start up and commissioning of the Novavax CZ facility.

Serve as liaison between site leadership, US Ops leadership, and the tech transfer teams to ensure successful implementation of the process.

Provide leadership and direct support on a variety of deliverables including commissioning, validation, tech transfer, engineering protocols, GMP execution, and process validation planning and execution.

In conjunction with site management, make key process related decisions when necessary.

Establish appropriate process performance monitoring systems and assist in evaluating process performance.

Interface with local and US based tech transfer teams to incorporate lessons learned on the COVID manufacturing process into the CZ facility.

Train local CZ operations personnel in cell culture and purification unit operation and troubleshooting.

Strong focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up and ability to make timely and sound decisions (Quality and Business).

Lead and/or support rapid troubleshooting of operational issues identified during site startup and GMP readiness.

Provide guidance to local CZ operations team on best practices for routine manufacturing operations, such as process scheduling, material flows, batch record authoring and process monitoring.

Bachelor degree in engineering or life sciences.

15 or more years of relevant experience and at least 5 years of management experience.

Prior experience in cGMP biologics manufacturing.

Ability to succeed in a team-oriented environment under very dynamic conditions.

Ability to collaborate with key stakeholders across a wide set of business disciplines

Highly Preferred/Desired Skills & Knowledge:

Experience with Sf9/BV expression system and manufacturing process.

Large scale commercial experience in technical or operational role.

Projec t management experience leading technical and/or complex projects.

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.

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Keywords: Novavax, Washington DC , Director, Manufacturing Science & Technology, Other , Gaithersburg, DC

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