Head of Drug Product & Formulation 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.
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.
As the leader of the CMC Drug Product & Formulation (DP) Development Team, this individual is accountable for planning and management of DP resources and budget and defining and delivering the Drug Product development strategy for GreenLight’s human health products.
Prior experience in proven track record in pharmaceutical operations is required. The ideal candidate will have a deep understanding of process development with expertise in formulation and filling from tox through launch.
This is a high-profile role requiring broad technical expertise and a result driven leader with exceptional people leadership skills, with the ability to influence strategic direction, develop and execute plans and inspire others to achieve desired results.
- This position will be responsible building a team from the ground up including hiring, training, and mentoring/coaching; this person will be accountable for managing the department, once built
- Drive the resolution of technical challenges in a timely fashion.
- Design and Execute Formulation & Process development for parenteral, biological products to achieve target product profiles.
- Oversee excipient selection, process optimization, scale up and validation applying QbD principles in line with the overall project strategy, with a focus on scale up and stability of lipid nanoparticles-RNA drug products
- Provide technical expertise and drive formulation development activities for complex and challenging assets.
- Actively contribute to writing key CMC sections of regulatory documents IND/IMPD/NDA/MAA; Convert data on formulations/products into knowledge required for regulatory filings.
- Support Tech Transfer across all phases of development and lifecycle, by overseeing various manufacturing/scale-up/validation activities and provide technical expertise to trouble-shoot manufacturing/packaging process issues.
- Lead, facilitate, and participate in technical discussions as subject matter expert in drug products to successfully resolve problems with suppliers, methods, project issues and deviations.
- Partner across departments and functions to ensure product quality, product stability, and optimal drug product design while delivering company milestones on time and in full.
- Collaborate with QA to ensure the quality of the company’s manufactured products and communicate appropriately to cross-functional teams and senior management.
PROFESSIONAL EXPERIENCE / QUALIFICATIONS
- Ph.D. in engineering or biological sciences Minimum 10+ years of experience in biotechnology, pharmaceutical or life science industry
- Expertise in DP manufacturing of sterile dosage forms including frozen, liquid, lyophilized and spray dried formulations
- mRNA and LNP experience highly desireable
- Experience managing diverse teams with a wide variety of experience and qualifications
- Proven track record of developing formulations and drug product designs that simplify storage, transportation, and delivery of the products
- Deep knowledge of formulation and drug product design of biopharmaceuticals
- Knowledge of current issues associated with drug products from stabilization to delivery
- Knowledge of FDA and EMA guidelines
- Experience writing successful IND and BLA/NDA submissions
- Knowledge of USP and Ph. Eur
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.