Senior Manager - Process Science and Validation, Drug Product

Employer
Novavax
Location
Gaithersburg, Maryland, United States
Salary
Competitive
Start date
23 Nov 2022
Closing date
23 Dec 2022

View more

Discipline
R & D
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

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.

Summary of the Position :

Novavax is seeking a Senior Manager for the Process Science and Validation Team in DP MS&T, to provide technical and managerial leadership, project management and technical support 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. 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 Drug Product MS&T Process Science and Validation personnel manager.

Responsibilities include but are not limited to :
  • Lead/Support the DP Manufacturing Organization in the selection, process development/tech-transfer, design, development, validation and management of global drug product CMOs.
  • Drive technical documentation in alignment with the defined goals of the organization taking into account all sourcing, tech transfer, development and equipment sourcing assumptions and provide weekly schedule updates as new information becomes available.
  • Define the manufacturing process control strategy for all DP process steps;, DS thaw through DP formulation, sterile filtration, aseptic filling, vision and CCI inspection, device assembly (optional) and final packaging and release for vials and prefilled syringes.
  • Support clinical and commercial manufacturing projects.
  • Partner with all departments and leaders to provide a high-level of support to manufacturing partners, and be prepared to act as mfg-site technical support.
  • Deliver robust, scalable, and cost-effective manufacturing processes that meet 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 team members to build and execute the CMC development 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.
  • Contribute to the writing and reviewing of eCTD section and technical supporting documents for INDs, BLA’s, MAA’s, and other variant 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 8+ years, MS 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 supporting the successful 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.

Every day our employees impact the future of health by preventing disease. To recognize their contributions, we offer them performance-based pay; a flexible, welcoming work environment; comprehensive and competitive benefits.

Novavax is headquartered in Gaithersburg, Maryland. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals 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 protected characteristic.

#LI-KC

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)

Company

We are a biotechnology company committed to help address serious infectious disease globally through the discovery, development, and delivery of innovative vaccines to patients around the world.

 

Our mission

We never rest in our quest to protect the health of people everywhere.

Novavax is here to make a difference. We’re a biotech company focused solely on developing life-saving vaccines to fight infectious diseases.

What sets us apart? Solid science tested by decades of research. Vaccines developed from trusted technology that are both safe and efficacious.

And a global network that will help ensure our vaccines reach everyone who needs them.

Find Us
Website
Mini-site
Novavax
Location
21 Firstfield Rd
Gaithersburg
MD
20878
US

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