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Key Responsibilities and Required Skills for a Vaccine Technologist

💰 $55,000 - $85,000

BiotechnologyPharmaceuticalsResearch & DevelopmentLife SciencesManufacturing

🎯 Role Definition

A Vaccine Technologist is a hands-on scientific professional who serves as the backbone of vaccine development and manufacturing. This individual operates at the intersection of science and engineering, executing the precise, highly-regulated processes required to create vaccines. They work within state-of-the-art laboratory and cGMP manufacturing environments, performing tasks from cell culture and fermentation to purification and final formulation. The role demands meticulous attention to detail, a deep understanding of biological processes, and an unwavering commitment to quality and safety, directly contributing to public health on a global scale.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Manufacturing Associate (Biopharma)
  • Research Assistant / Associate
  • Quality Control Analyst I

Advancement To:

  • Senior Vaccine Technologist / Lead Technologist
  • Process Development Scientist
  • Manufacturing Supervisor

Lateral Moves:

  • Cell Therapy Specialist
  • Downstream/Upstream Process Specialist
  • Quality Assurance Specialist

Core Responsibilities

Primary Functions

  • Execute complex upstream bioprocessing tasks, including the revival, expansion, and maintenance of mammalian, insect, or microbial cell cultures using aseptic techniques in flasks, cell factories, and wave bioreactors.
  • Operate, monitor, and maintain single-use and stainless-steel bioreactors or fermenters for vaccine antigen production, managing critical process parameters such as pH, dissolved oxygen, temperature, and nutrient feeds.
  • Perform downstream purification of vaccine components using various chromatography techniques (e.g., affinity, ion exchange, size exclusion) and tangential flow filtration (TFF) systems for concentration and diafiltration.
  • Execute viral vector production and viral clearance studies, handling live viruses or viral components in accordance with stringent BSL-2 or higher biosafety protocols.
  • Prepare sterile media, buffers, and other critical process solutions according to established formulations, ensuring precise measurements and component traceability.
  • Rigorously follow and document all activities in real-time on electronic or paper-based Batch Manufacturing Records (BMRs) in strict compliance with cGMP and data integrity (ALCOA+) principles.
  • Operate, clean, and maintain essential manufacturing equipment, including autoclaves, parts washers, biosafety cabinets, incubators, and analytical instruments, performing routine calibration checks as required.
  • Collect and submit in-process samples for quality control testing, and perform routine analytical tests such as cell counting, viability assessments, concentration measurements (OD600/A280), and pH/conductivity checks.
  • Conduct environmental monitoring within the cleanroom environment, including viable and non-viable particulate sampling, surface sampling, and personnel monitoring to ensure aseptic conditions are maintained.
  • Assist in the execution of process validation (PV) batches, equipment qualification (IQ/OQ/PQ), and cleaning validation protocols to support regulatory filings and facility readiness.
  • Troubleshoot process and equipment-related issues as they arise during manufacturing, documenting deviations and collaborating with supervisors and engineering to identify root causes and implement corrective actions.
  • Author, review, and revise Standard Operating Procedures (SOPs), batch records, and other technical documents to ensure they reflect current processes and cGMP standards.
  • Maintain meticulous inventory control of critical raw materials, consumables, and cell banks, ensuring proper storage conditions and "first-in, first-out" (FIFO) usage.
  • Adhere to all Environmental, Health, and Safety (EHS) guidelines, properly handling chemical and biohazardous waste and wearing appropriate Personal Protective Equipment (PPE).
  • Support technology transfer activities, working closely with Process Development teams to successfully scale up new vaccine processes from the lab to the manufacturing suite.

Secondary Functions

  • Participate actively in deviation investigations, contributing technical insights to root cause analysis and the development of effective Corrective and Preventive Actions (CAPAs).
  • Train and mentor junior technologists and new team members on specific techniques, equipment operation, and cGMP compliance, fostering a culture of knowledge sharing.
  • Contribute to continuous improvement projects (e.g., Lean, Six Sigma) by identifying opportunities to enhance process efficiency, reduce waste, and improve safety within the manufacturing environment.
  • Provide operational support during internal and external regulatory audits (e.g., by the FDA, EMA) by retrieving documentation and speaking to manufacturing processes and procedures.
  • Assemble, sterilize, and set up complex bioprocessing equipment and single-use flow paths prior to batch execution, performing integrity testing to ensure a sterile boundary.

Required Skills & Competencies

Hard Skills (Technical)

  • Aseptic Technique: Demonstrated mastery of sterile techniques for handling cell cultures and sterile materials to prevent contamination.
  • Cell Culture/Fermentation: Hands-on experience with mammalian (e.g., CHO, Vero), insect (e.g., Sf9), or microbial (e.g., E. coli, Pichia) cell lines in a manufacturing or lab setting.
  • Bioreactor Operation: Proficiency in operating and monitoring bench-scale or large-scale bioreactors/fermenters.
  • Downstream Purification: Practical knowledge of chromatography systems (e.g., ÄKTA) and Tangential Flow Filtration (TFF) / Ultrafiltration/Diafiltration (UF/DF) principles.
  • cGMP Compliance: Deep understanding and working knowledge of current Good Manufacturing Practices (21 CFR Parts 210, 211) and their application in a regulated environment.
  • SOP & Batch Record Execution: The ability to meticulously follow complex written procedures and document every step accurately and contemporaneously.
  • Analytical Instrumentation: Experience with basic analytical lab equipment such as pH meters, spectrophotometers, osmometers, and cell counters.

Soft Skills

  • Meticulous Attention to Detail: An unwavering focus on precision and accuracy, critical for process success and regulatory compliance.
  • Adaptability & Flexibility: Ability to thrive in a dynamic, fast-paced environment and adjust to changing production schedules, priorities, and technologies.
  • Collaborative Team Player: Strong interpersonal skills to work effectively with colleagues in manufacturing, quality, and process development to achieve common goals.
  • Systematic Problem-Solving: A logical and methodical approach to identifying, analyzing, and resolving technical issues with equipment and processes.
  • Proactive Communication: The ability to clearly and concisely communicate technical information, status updates, and potential issues both verbally and in writing.

Education & Experience

Educational Background

Minimum Education:

  • Associate's Degree in a scientific or technical discipline.

Preferred Education:

  • Bachelor's Degree.

Relevant Fields of Study:

  • Biotechnology
  • Biology / Microbiology
  • Biochemistry
  • Chemical Engineering

Experience Requirements

Typical Experience Range:

  • 1-5 years of hands-on experience within a cGMP manufacturing facility, pilot plant, or a highly regulated laboratory environment.

Preferred:

  • Direct experience in vaccine manufacturing (e.g., viral vector, mRNA, protein subunit, VLP), cell therapy, or large-molecule biologics production is highly advantageous.
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