Senior/Executive Director, Formulations
A small biotechnology company is seeking an experienced and motivated Senior/Executive Director of Formulations to lead and manage the development of injectable liquid formulations for their cutting-edge product pipeline, mainly focused in ophthalmologic and neurologic disease areas. In this critical role, you will be responsible for driving scientific excellence and leading a team of talented scientists to develop high-quality, scalable and cost-effective formulations that meet the highest standards of quality, safety and efficacy. This role has hybrid flexibility.
Duties and Responsibilities:
- Lead the formulation development team to ensure progress into phase 3 and NDA submission for clinical stage drug product candidates
- Collaborate with cross-functional teams, including Process Development, Analytical Development, and Regulatory, to ensure effective integration and alignment of efforts
- Ensure that all formulation development activities comply with regulatory requirements and Good Manufacturing Practices (GMPs)
- Foster a culture of continuous improvement, innovation and teamwork within the Formulations group
- Represent the Formulations Development group in internal and external meetings, and serve as a key liaison with regulatory agencies, CROs/CMOs and other stakeholders
- Manage budgets and resources effectively to ensure the successful delivery of projects
Qualifications:
- PhD in Pharmaceutics, Biochemistry, Chemical Engineering or related discipline with a minimum of 12 years of experience in pharmaceutical formulation and drug product development, with a strong focus on parenterals/injectables formulations in vial and/or pre-filled syringe presentations
- Strong leadership skills and experience leading and managing high-performing teams
- Extensive knowledge of quality management systems, cGMPs, regulatory requirements and experience with regulatory submissions
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
- Strong problem-solving skills, with the ability to think creatively and develop innovative solutions
- Demonstrated track record of delivering successful projects on time and within budget
- Background in lifecycle product management from commercial to the drug development process beyond pharmaceutical development
Benefits:
- Competitive health, vision, and dental benefits
- 401(k) plan with company match
- Annual bonus target as well as stock options
- Sponsored lunches on site and spirit weeks to foster a fun workplace
- Opportunities for advancement and growth within the company as it continues to expand and succeed
If you are a highly motivated and experienced professional with a passion for advancing the science of biotechnology formulation, please apply!
