Manufacturing Associate III
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If you find science, speed, and success exhilarating, you have come to the right place.
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 a highly motivated and versatile individual to join our manufacturing team as a Manufacturing Associate III in our Gaithersburg, MD facility. 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, as necessary. The role may at times require weekend or off hours work.
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.
- Accountable for daily adherence and execution of 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.
- Perform Safety Inspections of the Manufacturing Laboratory.
- Heavily contribute to building a strong team.
- Assist all levels of manufacturing associates in the completion of daily activities and tasks.
- Ensure materials are procured and staged in advance to ensure daily tasks are completed on time, all times.
- Engage in Operational Excellence activities to improve current processes and practices.
- Assist with operations only as properly instructed by experienced team members.
- Proactively pursuing training needs per assigned curriculum.
- Serve as SME/Trainer on multiple unit operations.
- Author SOP’s, OJT’s, and Batch Records.
- Perform introductory technical writing assignments.
- Fosters an environment of process ownership and real-time monitoring of process performance.
- Diagnose and troubleshoot complex problems.
- 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 in internal Audits.
- Assist with complex comments in GMP documentation while informing department management.
- Bachelor's degree (engineering or biological science is preferred) with 3+ year of industry experience, Associate degree with 3+ years of industry experience, or No degree with 5+ years of industry experience.
- Exhibit solid understanding of scientific principles as they relate to manufacturing processes.
- Technical Writing experience
- 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.
- Able to lift 35 lbs. without assistance.
- 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 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)
Gaithersburg, Maryland, USA
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