What are the responsibilities and job description for the Manufacturing supervisor position at Novavax, Inc.?
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.
Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.
Job Description :
Unique opportunity join the Novavax team as a Manufacturing Supervisor based in our Gaithersburg, Maryland offices. 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 :
Leading a team of several direct reports
Effective coaching and development of direct reports
Motivating, supporting, and providing guidance to production staff
Regular 1 : 1's with direct reports providing feedback on performance.
Establishing goals for direct reports
Ensuring manufacturing team is following all procedures and policies.
Ensuring safety and quality objectives are met
Oversight of Continuous Improvement Initiatives
Oversight of cell amplification - BDS operations
Serve as primary point of contact for escalation in the manufacturing areas.
Production Performance :
Accountable for oversight of daily adherence to production schedule and deviation avoidance across process suites.
Leads by example in maintaining a positive, safe, and compliant work environment through coaching and reinforcement of policies and procedures related to health, safety, and Good Manufacturing Practices.
Assist with leading daily work assignment schedules and coordinates work team activities to ensure adequate coverage of critical manufacturing steps.
Coordinates resources to ensure that equipment remains in good operating condition.
Technical Operations :
Works closely with Technology Transfer groups to implement process changes and improvements.
Assists with real-time investigation and triage of process and equipment deviations.
Fosters an environment of process ownership and real-time monitoring of process performance.
Identifies challenges in the current manufacturing processes and collaborates with Process Development to create more robust processes.
Review and approval of documents such as Master Batch Records, Standard Operating Procedures, and Deviation Investigations.
Partners with Operational Excellence team to learn, sponsor, and incorporate continuous improvement techniques.
Assists with technical group discussions.
Compliance :
Maintain work area in state of inspection readiness.
Reviews safety investigations.
Participates in internal and external audits and inspections.
Identifies quality-related trends and facilitates implementation of corrective actions.
Minimum Requirements :
Bachelor's degree (engineering or biological science is preferred).
Minimum 5 years' experience in GMP pharmaceutical, biologics and / or vaccine manufacturing in a manufacturing role.
Prior supervisory experience strongly preferred.
Demonstrates interpersonal, technical aptitude, and problem-solving skills.
Knowledge and expertise in principles and practice of current Good Manufacturing Practices (cGMPs) from development or commercial applications.
Knowledgeable of FDA regulations regarding the manufacture of biological including regulatory inspection experience.
Excellent analytical, organizational, and leadership skills.
Excellent 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.
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.
Last updated : 2024-05-02
