Associate Director, Process Science, Drug Product MS&T

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Novavax, Inc. (Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases. Novavax is uniquely qualified to address the enduring need for innovative vaccines. We utilize our proprietary recombinant technology platform, which combines genetic engineering's power and speed to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. 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.

Novavax is seeking an Associate Director for the Drug Product Manufacturing Science and Technlology (MS&T) Process Sciences and Validation (PSV), to provide technical and managerial leadership, for the design, development and validation and commercialization of Drug Product manufacturing within the domestic and international CMO network. The successful candidate will work cross functionally within DP Manufacturing, Quality, Regulatory, and the CMO teams to ensure successful implementation of drug product manufacturing processes and provide commercial support as needed to meet company timelines and objectives. He/She will also establish close working relationships across disciplines to advance multiple programs to ensure project demands ranging from clinical development to commercialization for drug product manufacturing process capabilities within our innovative and growing company. This position will report to the Vice President of Drug Product.

Responsibilities include but are not limited to:
• Lead management of PSV for Drug Product Systems that implement international CMOs that support EMA, FDA, TGA, WHO, etc.
• Develop and lead personnel that support drug product activity.
• Lead the DP PSV Manufacturing Organization in the selection, process development/tech-transfer, design, development, validation and management of global drug product CMOs
• Provide weekly updates on overall project status and schedule adherence with risk mitigations
• Lead problem solving and root cause analysis activities for Quality Events
• Support clinical and commercial manufacturing projects
• Deliver robust, scalable, and cost-effective manufacturing processes that meets or exceed the drug product specifications
• As a team member within MS&T, you will be asked to collaborate on new process development and validation strategies in-line with all cGMP’s and relevant ICH, FDA, EMA, MHRA and other global HA’s regulation/guidances.
• Collaborate with other CMC / project team members to build and execute the integrated CMC project plan
• Identify and proactively manage product / project risk and escalate risks through site management, consult with manager as needed
• Partnership with Process Development, Analytical Development, Drug Substance Manufacturing teams to guide generation of data, analytics, and process controls that meet operational needs
• Lead and/or support rapid troubleshooting of operational issues identified during site startup and GMP readiness
• Accountable for the evaluation of technical oversight of supplier-initiated changes and Drug Product process changes
• Serve as primary author and reviewer of eCTD section and technical supporting documents for INDs, BLA’s, MAA’s, and other variant, device, or supplemental regulatory submissions
• 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)
• Domestic and international travel will be required (15%-30%)

Minimum Requirements:
• BS, MS, or Ph.D in engineering, chemistry, biology, or related discipline
• BS with 10+ years, MS with 8+ years, or Ph.D with 6+ years experience in pharmaceutical or biological operations focused on late phase process transfer, pre-approval inspection, and clinical/commercial manufacturing is required
• Experience in personnel management preferred
• Technical support of products in both the sending and receiving unit capacity for development through commercial operations/implementation
• Knowledge of CMC development from clinical through commercialization
• Strong understanding of EU/FDA/WHO regulatory requirements associated with manufacturing of vaccine products
• Experience in oversight of CMOs for process optimization, characterization, technology transfer, and commercial operations
• Strong project 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 to peers and Sr. Management is expected
• Position is remote

Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

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.

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)

Job details
Process Development and Manufacturing
Remote Maryland
Gaithersburg, Maryland, USA
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