Senior Director, Formulation

Job Description

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 Senior Director in Formulation Development will lead a team of scientists working on 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.

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.
• Supervise a team of formulation scientists primarily dedicated to formulation design and process scale-up activities.
• Be a member of the department leadership team
• 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.
• Be responsible for quality of direct report's scientific and quality output and maintaining a safe work environment.
• Mentor/develop direct reports to meet or exceed ever increasing project team deliverables and prepare to assume greater responsibilities.
• Deep and broad understanding of sciences related to drug discovery and development
• Author and review technical reports, regulatory filings, source documents, patents and external publications.
• Represent Vertex at external meetings with Regulatory Authorities as needed.
• Accountable for troubleshooting and resolving high complexity formulation challenges.

Knowledge and Skills:

• 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.
• Lead a team to advance projects from exploratory development through various clinical stages to commercial validation.
• 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.

Education and Experience:

• PhD degree in pharmaceutical sciences, chemistry, chemical engineering, materials science or related field with 11+ years of relevant industrial experience
• In depth functional/scientific expertise in formulation development with industry recognition
• Demonstrated ability to apply advanced scientific principles (e.g. thermodynamics, kinetics, and materials science etc.) to formulation and process development.
• 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
• Experience with regulatory filings (IND/CTA, NDA/MAA) and health authority interactions
• Demonstrated experience in leading technical teams and project teams
• Managerial/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. biologics, parenteral and inhalation products) is a plus

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Flex Designation:

Flex Eligibility Status:

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com