Quality Control Analyst - HPLC
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.
About the company: GreenLight Biosciences solves big problems facing society in agriculture, human health, and animal health through scientific innovation. Our pipeline of biopesticides have similar efficacy to traditional chemical pesticides while being safe to both non-target organisms like pollinators and the environment. The company is currently building on expertise in the cost-effective production of RNA to rapidly accelerate efforts in life sciences. Using our proprietary mRNA platform and collaboration with leading industry partners, GreenLight is developing a pipeline of RNA based vaccines and therapies to address critical public health challenges. The GreenLight team is over 200 people across our headquarters in Medford, MA and an R&D facility in Research Triangle Park, NC. Construction is underway on a pilot scale biomanufacturing plant in Rochester, NY.
Key Position 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 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.
- Author, 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.
- 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 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 along with advanced skills with MS Office applications and Adobe Acrobat.