Manufacturing Associate II

Posted:
7/24/2024, 5:00:00 PM

Location(s):
Maryland, United States ⋅ Gaithersburg, Maryland, United States

Experience Level(s):
Junior ⋅ Mid Level ⋅ Senior

Field(s):
Product

If you find science, speed, and helping address serious infectious diseases exhilarating, you have come to the right place.

Individually, we’re skilled, driven, and confident risk-takers. Collectively we're collaborative and accomplished. We're SuperNovas!  Together we use our unique experiences, cultures, and learnings to turn innovation into reality while maintaining the highest standards. We value balance, encourage growth, and recognize that you are our most important asset.  Build your future with us while bringing innovative vaccines to the world.  We have a place for you!

Novavax, Inc (Nasdaq:NVAX) is a biotechnology committed to helping address serious infectious diseases globally through the discovery, development and delivery of innovative vaccines to patients around the world. We have more than a decade of experience contending with some of the world’s most devastating diseases, and we are here to make a difference. Hard-won lessons and significant advances illustrate that our proven technology based on solid science tested by decades of research, has tremendous potential to make a substantial contribution to public health worldwide.

Job Description:

We are looking for highly motivated and versatile individual to fill a challenging yet rewarding role on our vaccine manufacturing team in Gaithersburg, MD. This role requires a diverse skill set to assist with a variety of technical, operational, and project responsibilities.  Must be highly flexible and collaborative to drive cross-functional success at the site and coordinate with tech transfer teams. 

Responsibilities include but are not limited to:

  • Cell amplification of suspension-based insect cells through shaker flasks, bioreactors, and disposable bioreactors.

  • Infection and harvest processes using continuous centrifugation and depth filtration.

  • Purification steps using flow-through and column capture chromatography.

  • Drug substance formulation.

  • In-house buffer preparation and support activities.

Production Performance:

  • Responsible for daily adherence to production schedule.

  • Diagnose and respond to unusual conditions with proper communication to management.

  • Perform tasks with a safety-first mentality and awareness of surrounding environment.

  • Work under cGMP conditions with general guidance for tasks with prior experience.

  • Work with trained colleagues for operations with no prior experience.

Technical Operations:

  • Assist with operations only as properly instructed by experienced team members.

  • Proactively pursuing training needs per assigned curriculum.

  • Serve as SME/Trainer on at least one unit operation.

  • Author SOP’s and Batch Records.

  • Perform introductory technical writing assignments.

Compliance:

  • Assist in maintaining work area in state of inspection readiness.

  • Adhere to cGMP and GDP guidelines.

  • Operate only in accordance with an approved process or document.

  • Report any instance of a procedure or document being insufficient for processing to department management.

  • Assist with complex comments in GMP documentation while informing department management.

Minimum Requirements:

  • Bachelor's degree (engineering or biological science is preferred) with 1+ year of industry experience, Associate degree with 2+ years of industry experience, or No degree with 3+ years of industry experience.

  • Experience with cell culture operations

  • Exhibit solid understanding of scientific principles as they relate to manufacturing processes.

  • Demonstrate interpersonal, technical aptitude, and problem-solving skills.

  • Knowledge in principles and practice of current Good Manufacturing Practices (cGMPs) from development or commercial applications.

  • Effectively contribute to a team environment with safety at the forefront.

  • Flexible availability including weekends and holidays.

  • Experience with multi-tasking and organizational skills.

  • Show proficiency in verbal, written, and interpersonal communication skills.

  • Ability to troubleshoot, identify root causes, and systematically resolve problems.

  • Proficient in Window based software to include Excel and Word. Ability to adapt to changing software programs.

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.