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Senior CMC Project Manager

Employer
GreenLight Biosciences, Inc.
Location
Medford, MA
Start date
Dec 7, 2021

View more

Discipline
Science/R&D, CMC
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown

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

We are seeking an experienced individual to drive the delivery of pipeline assets and technical projects. The Sr CMC Project Manager will be responsible for Clinical-staged programs and project management functions, which includes all Chemistry, Manufacturing, and Controls (CMC) activities for GreenLight’s programs from toxicology through commercial manufacturing and supply. The successful candidate will be results-driven, highly organized and have a proven track record in managing and driving project success within CMC in the pharma/biotech industry. 

This role requires someone with excellent leadership and teambuilding capability, capability of driving cross-functional collaboration across the company, and a willingness to play an active, behind-the-scenes role. The successful candidate will be a highly resourceful individual with strong emotional intelligence, self-motivation, and strong analytical and execution skills.

MAJOR RESPONSIBILITIES

  • Partner with the cross-functional team as we manage multiple, complex activities across Drug Substance, Drug Product, Supply Chain, Quality, Analytical and Regulatory CMC.
  • Partner closely with all key stakeholders of the internal GreenLight team and external CDMOs to develop and maintain integrated project plans to identify/communicate interdependencies as well as critical path activities for the project.
  • Conduct scenario planning and provide analysis and recommendations on development plans and periodically present to leadership to ensure alignment.
  • For each project followed, (1) prepare and maintain detailed project budgets timelines, and dashboards, (2) track the status of all ongoing development and manufacturing activities and regularly present project status updates.
  • Ensure team members are aware of integrated project timelines and provide timely updates of status and cross-functional impact.
  • Facilitate team meetings using project management best practices/tools to drive cross-functional communication, timely and effective decision making, and successful execution of project objectives.
  • Organize and maintain team communications including meeting agendas, minutes, decision logs, tasks lists, and risk analyses/mitigation strategies. Develop project management tools/templates to facilitate timely communication and execution of projects.
  • Facilitate budgeting/forecasting/long-range planning activities for assigned projects
  • Effectively manage internal and external resources to achieve project milestones
  • Identify gaps in processes, and then work with appropriate parties to develop, and implement solutions
  • Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable

 

PROFESSIONAL EXPERIENCE / QUALIFICATIONS                                                                  

  • 8+ years of operational pharmaceutical experience across a breadth of functions including, manufacturing operations, bioprocessing technology, supply chain, CAPEX
  • Robust knowledge of GMP and regulations and a strong technical understanding of manufacturing and product and process development
  • Demonstrated understanding of core business functions
  • Proven track record of leading successful change agendas; accountability for delivery; ownership and resolution of problems
  • Strong foundational collaboration skills with experience working in a successful matrix managed environment.
  • Ability to navigate a fast-paced environment with a high degree of ambiguity
  • Strong, agile strategic and financial analysis skills
  • Mission-driven; passionate about GreenLight’s values and objectives
  • Excellent communication skills, with the ability to influence and engage across all levels of the corporation from the Board of
  • Directors to the lab bench and with external stakeholders
  • Good sense of self and strong personal presence
  • Ability to demonstrate initiative, suggest improvements to current systems as well as establish new processes
  • Meticulous attention to detail and accuracy
  • Willing to get involved in ad hoc projects or assist other teams as needed with a can-do attitude 
  • Able to thrive in a highly dynamic, fast paced, continuously changing global environment with minimal oversight/direction.

 

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.

 

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