Job Description

Research Associate, QC

Location: Woburn, MA

Vaxess Technologies is developing next-generation vaccines and therapies based on its microneedle array patch (MAP) platform. The Vaxess microarray patch enables intradermal delivery of vaccines and therapeutics to enhance efficacy and simplify administration. We are committed to enabling products that are not only more effective but also more accessible to patients around the world.

Research & Development at Vaxess is cross-disciplinary, integrating biology, chemistry, immunology, materials science, and engineering to address important unmet medical needs in vaccines and therapeutics. We are seeking a talented, collaborative, and highly motivated individual with expertise in environmental monitoring and cleanroom QC operations to join our core team of scientists and engineers. The Research Associate will execute environmental monitoring, support cleanroom operations, and contribute to analytical testing to ensure compliance with cGMP requirements. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market.

Key Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

·Conduct viable and non-viable environmental monitoring in classified cleanroom areas, including air, surface, and personnel monitoring.

·Perform routine and non-routine cleanroom qualification, including particle counts, viable air sampling, and surface swabbing.

·Support environmental monitoring trending, data review, and deviation investigations.

·Maintain detailed, accurate records in compliance with cGMP and data integrity requirements.

·Support cleanroom gowning, aseptic technique, and contamination control training programs.

·Collaborate with Quality and Operations teams to ensure compliance with facility and product requirements.

· Prepare detailed reports and summaries of findings for management.

·Assist in the development and execution of protocols for cleanroom and facility qualification.

·Participate in audits and inspections as needed.

·Support routine and non-routine analyses of drug substances, intermediates, and drug products using techniques such as pH, HPLC, SEC, viscometry, and UV-Vis spectroscopy.

·Work effectively in a fast-paced, team-oriented environment with strong oral and written communication skills.

·Maintain accurate, detailed laboratory records and ensure compliance with data integrity standards in electronic lab notebooks.

·Collaborate cross-functionally to support project success and meet organizational goals.

Qualifications

·Bachelor’s degree with at least 2 years of relevant experience, or a master’s degree in microbiology.

·Proficient in environmental monitoring techniques, including viable/non-viable particle monitoring, surface sampling, and cleanroom qualification.

·Familiarity with aseptic processing, contamination control, and cGMP cleanroom operations.

·Strong analytical, problem-solving, and critical-thinking skills.

·Excellent attention to detail and organizational skills.

·Effective written and verbal communication skills.

·Ability to work both independently and collaboratively in a team environment.

·Experience in a QC/GMP laboratory is a plus.

Vaxess, a venture-backed life sciences company, is building a team of exceptional people to rapidly advance products on its microneedle array platform. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment. If you’re interested in joining the Vaxess team, please submit your CV/resume to [email protected] .

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