Head of Attribute Sciences

Location
Medford, MA
Posted
Oct 05, 2021
Ref
4143709004
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time

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 characterization expert to build and lead an attributes sciences group. This role will report into the Head of Analytical Development and will be responsible for analytical characterization studies in support of early- and late-stage regulatory submissions, CQA/non-CQA determinations, comparability, reference standards, control strategy, and investigations.

The successful candidate will be accountable for driving CMC analytical characterization efforts from toxicology through commercial stages, as well as hiring and managing a team of scientists. The position offers a unique opportunity for a self-starter to join us in a fast-paced and collaborative environment.

MAJOR RESPONSIBILITIES

  • Build and lead an attribute sciences organization at GreenLight; oversee the overall scientific, technical, and operational efforts related to characterization of mRNA therapeutics and vaccines from GLP toxicology through commercial stage
  • Develop science-driven, phase-appropriate, and risk-based analytical development strategies related to comparability and reference standard characterization, CQAs, and analytical controls using QbD principles
  • Drive structure/function studies to advance product and process understanding
  • Author or review analytical characterization sections of regulatory submissions
  • Partner with R&D teams to enhance mRNA platform understanding and establish a developability business process
  • Build scientific knowledge and capabilities in CMC analytical characterization; establish partnerships with external vendors to leverage capabilities not available in-house
  • Deliver timely and impactful data and process knowledge to meet project milestones and associated regulatory requirements; this includes the design of protocols, execution of experiments, and reporting and documenting data in characterization reports
  • Staying current with state-of-the-art approaches and applicable global regulations and industry standards
  • Participating or leading effectively in internal projects and external collaborations by representing the analytical development organization as needed

EDUCATION

  • Ph.D. in a relevant scientific discipline

PROFESSIONAL EXPERIENCE / QUALIFICATIONS

  • Minimum of 10 years of experience in analytical development, including late-stage analytical characterization studies
  • Experience working with a variety of modalities; expertise in analytical characterization of RNA is a strong plus
  • Knowledge and experience working in a regulated pharmaceutical environment, specifically with respect to product and process development from discovery through commercialization
  • Direct experience with CMC analytical and regulatory requirements, including development of control strategy to support late-stage product development and readiness for process characterization and registration submissions
  • Hands-on experience with and in-depth understanding of a variety of analytical techniques, including but not limited to mass spectrometry, HPLC, CE, and biophysical methods
  • Design and execution of structure-function and other characterization studies to evaluate CQAs
  • Extended characterization to determine comparability and establish reference standards
  • Understanding of QbD concepts and their implementation
  • Demonstrated skills in managing people and their careers
  • Ability to self-start and work autonomously in a fast-paced environment
  • Proven leadership ability to align, motivate, and empower team members
  • 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.