Sr Scientist / Sr Manager - Upstream process development

Location
Medford, MA
Posted
Jan 05, 2022
Ref
4195202004
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time

ABOUT GREENLIGHT

GreenLight Biosciences solves big problems facing society in agriculture, human health, and animal health through scientific innovation. GreenLight Biosciences is dedicated to bringing our cell-free RNA production process to market. Our work will lead to more sustainable global development, and we promise to deliver our safe solution without compromising the Earth and its people. One of the small coterie of early RNA-focused biotech startups, GreenLight Biosciences was founded in 2008, raised its most recent round this year and has a broad portfolio addressing key issues in plant health and human health. The GreenLight team is over 200 people across our headquarters in Medford, MA, an R&D facility in Woburn, MA and an R&D facility in Research Triangle Park, NC. GreenLight also has a pilot scale biomanufacturing plant in Rochester, NY. Initiatives include finding ways to support biodiversity, protect bees and other pollinators, treat rare diseases such as Sickle Cell Disease as well as develop vaccines for seasonal flu and the current COVID-19 pandemic

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

GreenLight Biosciences is seeking an exceptional and highly motivated process scientist to help advance the company’s mRNA platform technology for human health products. The successful candidate will support R&D efforts within the company by leading a team developing scalable USP processes for therapeutic RNA production. A deep technical background in fermentation process development is required. Experience with late-stage bio-pharmaceutical process development is preferred. Strong leadership, communication skills, creative problem-solving, project management and flexibility are essential.

MAJOR RESPONSIBILITIES

  • This position will be the primary liaison between internal process development teams and Contract Development and Manufacturing Organizations (CDMOs).
  • Lead the Fermentation team in the Drug Substance Process Development group, developing fermentation processes for production of mRNA starting materials and enzymes
  • Guide internal teams in evaluating process robustness through risk assessments, DOE approaches, characterization, and in-process control evaluation in collaboration with MSAT and manufacturing teams.
  • Independently design and execute fermentation production experiments, interpret data, and work with team members to integrate results into process designs and overall project plans
  • Support process scale-up and tech transfer activities to pilot plant, clinical and commercial manufacturing sites across the network
  • Author and review reports and CMC sections for regulatory filings
  • Work in collaboration with multidisciplinary project teams, as well as the Analytical Chemistry and Metabolic Engineering groups
  • Maintain diligent and organized records
  • Clearly communicate results and recommendations to colleagues, managers, and senior management, assisting in project decision-making

 PROFESSIONAL EXPERIENCE / QUALIFICATIONS

  • Ph.D. in Chemical Engineering, Biochemistry, Molecular Biology, or related discipline with at least 5 years of bio-pharmaceutical industry experience, specializing in Fermentation Development. Candidates with a M.S. and at least 8 years of bio-pharmaceutical experience will also be considered.
  • Broad knowledge of the overall pharmaceutical development and commercialization process
  • Experience in managing process development and process characterization at CDMOs
  • Experience in leading CMC upstream process development teams
  • Experience with fermentation process development, scale up and DOE approaches is required, experience with cell-free production processes is desirable
  • Understanding of cGMP, quality-by-design, ICH and other regulatory guidelines as they relate to product development, process characterization, control strategies and commercial manufacturing is expected.
  • Experience with process validation and authoring of BLA sections is preferred
  • Experience with primary clarification methods for cell cultures is desirable
  • Strong organization, communication, and interpersonal skills are required, with the ability to work both independently and in a collaborative work environment

 

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.