Quality Control Analyst - HPLC

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Job description

ABOUT GREENLIGHT

GreenLight Biosciences is an integrated life sciences company developing safe and effective products that address critical problems facing plant health, human health, and animal health. Through scientific imagination and determination, we are developing products to create a future with a cleaner environment, healthier people, and a stronger food supply chain. At the core of the company's rapid growth is a proprietary platform for higher quality RNA production at a lower cost and faster speed than has ever been possible.

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 .

About the position:

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. The company is looking for a key individual to play a pivotal role in advancing breakthrough therapies to rapidly address emerging pathogens. Reporting directly to the QC Laboratory Sr. Manager, the individual will be a key contributing member of our Life Science Team. The position will assist in establishing and running a Quality Control (QC) Laboratory providing support to the advancement of mRNA based human vaccines and other RNA based therapeutics. The ideal candidate will have the skills and experience necessary to build and equip a QC laboratory capable of supporting development, pre-clinical, clinical, and eventual post-marketing approval analytical testing.

Key Responsibilities

This position will assist with developing and implementing the QC laboratory systems used to support the development and manufacture of RNA-based products intended for use in humans.

As product development occurs, the QC Analyst will be responsible for the following activities:

• Perform cGMP HPLC analytical testing for release and stability.
• Review and evaluate raw data (peer review level).
• Perform stability / batch data trending as needed.
• Author SOPs/Forms and technical reports.
• Initiate laboratory deviations and support investigations (OOS), performing assessment, authoring protocols/reports and investigation closure.
• Review, and execute equipment validations.
• Support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training).
• Execute phase-appropriate test method qualification / validation protocols as needed.
• 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.
• Other duties as needed.

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.

Position Requirements

• Bachelor's degree with 2 - 4 years in a biotechnology discipline or MS 1 - 2+ years.
• 1 - 2 years of experience in a cGMP/GxP environment is preferred.
• Strong working knowledge of HPLC methodologies including basic troubleshooting. Previous experience with Agilent Openlab.
• 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 along with advanced skills with MS Office applications and Adobe Acrobat.

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 consistent with OSHA guidelines.