Scientist, Analytical Development – Greenlight Biosciences – Medford, MA

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 www.greenlightbio.com.


POSITION

We are seeking an analytical scientist responsible for the development of analytical methods for characterization and control of our products and processes, the creation of fundamental product and process understanding, and the advancement of innovative approaches to drug development. The incumbent will be highly motivated to work in a science driven and collaborative environment to achieve GreenLight’s program milestones. The successful candidate will have experience in late-stage development of physicochemical methods and should be able to work with minimal supervision to carry out laboratory based de novo analytical method development and characterization activities for GreenLight’s RNA vaccines and therapeutics.


MAJOR RESPONSIBILITIES

  • Develop robust analytical methods to determine purity, content, impurities & related substances in accordance with the Analytical Target Profile (ATP) and CQAs of the product
  • Design and execute phase-appropriate qualification of analytical methods in accordance with applicable regulatory guidelines
  • Support raw material de-risking as well as drug substance and drug product impurity characterization and identification
  • Develop and implement fit-for-purpose methods to analyze in-process samples and to enable process development, tech transfer, and manufacturing
  • Act as subject-matter expert during investigations, for interpretation of process analytical data, and for method transfers to internal Quality Control and external contract laboratories
  • Author or review technical documents to support regulatory submissions, including IND/CTA and registration applications
  • Review analytical data for completeness and correctness
  • Report and discuss analytical results and conclusions both orally and in writing

EDUCATION

  • Ph. D. with at least 3 years of industry experience
  • M.S. with at least 5 years of industry experience
  • B.S. with at least 7 years of industry experience

PROFESSIONAL EXPERIENCE / QUALIFICATIONS

  • Expertise in analytical method development and qualification/validation
  • Experience transferring analytical methodology to Quality Control and/or external contract laboratories
  • Proven track record of delivering high quality reproducible assay results in support of process development
  • Knowledge and experience working in a regulated pharmaceutical or biotech environment, specifically with respect to late-stage CMC development, and a solid understanding of the role of Analytical Development
  • Knowledge and experience with product characterization is a plus
  • Prior experience working with analytical methods for RNA-based vaccines or therapeutics is a strong plus
  • Subject-matter expertise with experience on-boarding junior scientists
  • Strong capabilities in experimental design and execution
  • Hands-on experience with and in-depth understanding of a variety of analytical techniques, including but not limited to plate-based, content (e.g., SoloVPE), HPLC, CE, qPCR, and biophysical methods
  • Ability to self-start and work autonomously in a fast-paced environment
  • Demonstrated critical thinking, problem solving, and innovation capabilities
  • Effective collaboration, communication, and negotiation skills

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.

Source: Indeed.com
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