Director, Formulation

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General Summary: Vertex is seeking a talented individual to join our Formulation Development group in Boston, MA. Formulation Development group is a fast paced and high energy environment.
The Director in Formulation Development will lead the advancement of drug candidates from exploratory development through commercial line extension in a Quality by Design (QbD) environment using lab based and computational tools to design and select solid dosage forms and manufacturing process. The successful candidate will: Apply thoughtful ideas and scientific rigor to understanding the relational effects of small molecule formulation design and deep process understanding to achieve excellent bioperformance and to deliver robust dosage forms for clinical and commercial use. Challenges will include working with small molecules of poor water solubility that require extensive application of bioavailability enhancing techniques, as well as overcoming processability and scalability issues utilizing different formulations. Work in a multidisciplinary cross-functional environment, where “Fearless Pursuit of Excellence” and “We Wins” are everyday values. Proven track record of applying fundamental scientific and engineering principles to formulation design, development, and process understanding. In depth knowledge of statistical analysis.
Key Duties and Responsibilities: Deliver and oversee the optimization of formulation and process understanding through rational experimental design, thoughtful execution and clear data interpretation, with a heavily emphasis on statistical analysis. Developing strategy for formulation and process development and the corresponding regulatory submissions Utilize and support the use of a mixture of computational models, small scale characterization tools, and knowledge based guidances to efficiently develop a formulation that has excellent bioperformance and can be readily manufactured at the clinical and commercial scale. May supervise a small team of formulation scientists primarily dedicated to formulation design and process scale-up activities. Helps define scientific direction and champion technological innovation for the department Collaborate within CMC teams as the Formulation lead and actively contribute to deliverables and engage in team discussion on issue resolution. Serve as CMC project lead as needed. Execute and oversee technical transfers, scale up and clinical manufacture at internal and external drug-product GMP facilities. Identify and manage CMOs and/or external collaborations Draft and review presentations relevant to formulation development activities and present to various management levels. Mentor/develop junior scientists to meet or exceed ever increasing project team deliverables. Demonstrate a practical understanding of related disciplines and work practices of key stakeholder functions Author and review technical reports, regulatory filings, source documents, patents and external publications. Accountable for troubleshooting and resolving high complexity formulation challenges.
Knowledge and Skills: Proven track record of applying fundamental scientific and engineering principles to formulation design, development, and process understanding. In depth knowledge of statistical analysis. Demonstrated advance technological leadership. Expertise in formulation process scale-up and optimization from laboratory scale to pilot scale and readily applies engineering scale-up principles Strong background in applying statistical approaches in the design and analysis of experiments and experience with Quality by Design (QbD) Strong background in GMP manufacturing and experience with early and late stage drug product development and regulatory filings (IND/CTA, NDA/MAA) Experience in leading technical teams, project teams and direct supervisory experience Proven teamwork, leadership and collaboration skills, with a demonstrated ability to interact and influence manage all levels of business Expertise with alternative modalities or delivery routes (e. g. bio logics, parental and inhalation products) is a plus
Education and Experience: PhD in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 9 years experience in life sciences, engineering or academia, or Master's Degree in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 12 years experience in life sciences, engineering or academia, or Bachelor's Degree in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 15 years experience in life sciences, engineering or academia
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Location:
Boston

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