Head of Analytical Development
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.
The GreenLight team harnesses the principles of equality and diversity to push the boundaries of scientific discovery and to stay focused on making a difference. This works because inclusion is a part of who we are and guides both our business decisions and how we work together. We take pride in our talented teams, our technology, and the solutions we deliver to protect the health of people and to feed our plants. For more information, visit www.greenlightbio.com.
This position will be responsible for the Analytical Development function for GreenLight Bioscience’s mRNA therapeutic programs from the pre-clinical through late-phase clinical stages. This person will work in close collaboration with the cross-functional CMC team and will direct, oversee, and deliver scientific and regulatory analytical strategies, including but not limited to method development, method validation, phase-appropriate control strategies, characterization, and comparability. This work will be driven using Quality by Design principles.
- Using the principles of QbD, provide technical and strategic leadership in the establishment of phase-appropriate analytical control strategies and the development of analytical methods for in-process and product release testing, and product characterization across the development lifecycle of GreenLight’s Human Health products.
- Author/review/approve key documents such as analytical target profiles (ATP) comparability protocols, control strategies, relevant sections of regulatory documents (IND, BLA), etc.
- Direct the preparation and approval of comprehensive supporting documentation for developed analytical methods.
- Maintain strong strategic partnerships across CMC partners to drive programs through clinical development efficiently and effectively.
- Build upon and shape the scientific knowledge, capabilities, and strategies that enable fast-to-clinic/fast-to-market product development for mRNA based vaccines and therapeutics
- Participate in external meetings, workshops, working groups to provide leadership and influence in the space of mRNA therapeutics.
- Build and lead a strong Analytical Development team by providing guidance and mentorship. Provide and prioritize learning and development opportunities to build the skills and capabilities of the team.
PROFESSIONAL EXPERIENCE / QUALIFICATIONS
The candidate has a broad understanding of QbD based pharmaceutical development and CMC-related activities, including extensive in-depth and hands-on experience with analytical development across the product and process development lifecycle, with a focus on vaccines/biologics. Excellent leadership, communication, and collaboration skills, along with the ability to be nimble and work in a fast-paced environment are crucial.
- Masters or Ph.D. in life sciences-related discipline with 10+ years of pharmaceutical development experience.
- Proven leadership and delivery of new assets from discovery to market.
- Hand-on experience in analytical development and technology transfer for vaccines and advanced biological therapies (cell, gene, mRNA therapies), across all phases of development through to launch.
- Deep knowledge of phase-appropriate, ATP-based analytical method, and assay development, qualification, and validation requirements compliant with current global regulatory standards; experience with vaccines preferred, or advanced biologics such as mRNA, gene, or cell therapy.
- Experience in directing the development and implementation of analytical control strategies, characterization, and comparability approached, with a focus on advanced biologics, including but not limited to cellular, molecular, biochemical, immunological, and physicochemical methods
- Understanding of product development life cycle and stage gates from research to clinical development to commercial operations
- Advanced knowledge of FDA, EMA, and ICH regulations, industry standards, and quality control principles for GMP operations
- Experience with writing validation protocols, validation reports, relevant sections of regulatory documents, IND, IMPD, and BLA
- Excellent communication, collaboration, team-building skills, and interpersonal skills; genuine desire to be on a team and contribute to organizational and team goals
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.