Senior Research Associate, Quality Control

Number of employees

300

Lexington, Massachusetts, United States

Posted on: 2023-03-09

Category: climate

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Employment type:

Full time

Experience required:

Senior

Salary

Salary not provided

About the company:

GreenLight Biosciences is a mission-driven public-benefit corporation using the power of RNA to tackle some of humanity's greatest challenges, including pandemics, rare diseases, biodiversity and climate change.


ABOUT GREENLIGHT

At GreenLight we are working to solve two of the world's greatest problems: global food insecurity and equal access to vaccines and the associated health benefits. Unlike most corporations who can be required to put profits ahead of other principles, GreenLight is one of the first Public Benefit Corporations to be publicly traded and have a charter that requires a focus on how it benefits its employees, community and society and has a broad portfolio addressing key issues in plant health and human health (Nasdaq: GRNA) by leveraging the full potential of dsRNA and mRNA. The GreenLight team is a  little over 260 people across our headquarters in Lexington, MA, an R&D facility and an R&D facility in Research Triangle Park, NC. GreenLight also has a biomanufacturing plant in Rochester, NY. Initiatives include finding ways to support biodiversity, protect bees and other pollinators, treat rare diseases as well as develop vaccines.

At GreenLight, we believe inclusion is the way forward. We celebrate the power of working together to address humanity’s challenges, meet the needs of underserved populations, and push the boundaries of scientific discovery. Fueled by our aspiration for a true sense of belonging, our talented teams embody the principles of diversity and equality as we strive to bring food security, medicine, and healthcare to everyone—paving the way for a sustainable future. For more information, visit www.greenlightbio.com.

POSITION SUMMARY

The GreenLight team is looking for a high-performing, self-motivated individual who works well in a fast-paced environment in a leading-edge biotech company. This role is an exciting opportunity to support development of new LNP-mRNA vaccine candidates to help advance the company’s pipeline and RNA platform technology. Reporting directly to the QC Laboratory Manager, the individual will be a key contributing member of the team assisting in establishing new workflows, leading documentation efforts, and focusing on GMP manufacturing activities. The position will support the qualification of analytical test methods, release of production materials, and stability testing and reporting of mRNA vaccines and other RNA based therapeutics. The ideal candidate will have expertise in HPLC and bioanalytical test methods to enable analytical testing needs within the QC laboratory.

MAJOR RESPONSIBILITIES

  • Maintain and improve QC laboratory systems used to support the development and manufacture of RNA-based products intended for use in humans, including equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training.
  • Support the analytical control strategy for raw material release by maintaining proper documentation, working with vendors and CROs, and confirming specifications are met.
  • Manage GMP stability study reports for multiple vaccine clinical development programs by performing stability / batch data trending per ICH Q5C.
  • Perform cGMP analytical testing for release and stability using HPLC, CE, qPCR and ELISA
  • Review and evaluate raw data (peer review level).
  • Author and review SOPs/Forms and technical reports.
  • Initiate and own laboratory deviations/CAPAs and support investigations (OOS), performing assessment, authoring protocols/reports and investigation closure.
  • Author, review, and execute equipment validations.
  • Execute phase-appropriate test method validation protocols, conduct validations, and issue validation reports.
  • Participate in providing the necessary information for regulatory filings and inspections.
  • Participate in audits (internal and external) and in remedial actions for any non-compliance.
  • Collaborates with internal and external stakeholders and partners to ensure that regulatory agency quality assurance requirements are met.  
  • May assist with auditing Contract Research Organizations as well as assist with hosting regulatory agency (e.g., FDA) inspections.

PROFESSIONAL EXPERIENCE / QUALIFICATIONS

  • Strong working knowledge of HPLC methodologies including basic troubleshooting. Previous experience with Agilent Openlab considered a plus.
  • Hands-on experience working with analytical methods such as: HPLC, CE, qPCR, and ELISA.
  • Previous experience with mRNA considered a plus.
  • Superb organizational, analytical, and communications skills and “do-what-it-takes” attitude.
  • Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment.
  • Knowledge of applicable GMP regulations, ICH & FDA guidelines, USP, and other applicable regulatory guidances (US and EU).
  • Ability to succeed in a team-oriented environment under very dynamic conditions. Must possess excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff and management across functional groups and levels.
  • ELN and LIMS experience preferred

 EDUCATION

  • Bachelor’s degree with 6-8 years, or MS 5+ years in a biotechnology discipline.
    1-2 years of experience in a cGMP/GxP environment is preferred.

 

Greenlight Biosciences Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

GreenLight requires proof of COVID-19 vaccination for its employees.

 

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