Formulation Research Scientist
The Formulation Research Scientist will work with other scientists dedicated to advancing 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 dosage forms and manufacturing process.
Key Duties and Responsibilities:
Develop dosage forms for clinical and commercial use
Develop stable and bioavailable formulations for different stages of development (e.g., solution/suspension based formulations, amorphous pharmaceutical systems into solid oral dosage forms, parenterals, etc.)
Help to design, execute experiments and analyze, and present results
Generate data for project progression and regulatory filings, conduct optimization and process scale up studies
Maintain accurate and complete laboratory notebook capturing protocols, results and observations
Interpret data to form sound conclusions and perform experimental troubleshooting on a routine basis
Perform basic statistical analysis of experimental data
Timely document integrated experimental outcomes in presentations and research reports
Transfer of technical knowledge to contract research sites (CRO) for onsite clinical preparations
Oversight of outsourcing activities such as scale-up and technology transfer to contract manufacturing sites (CMO) partners for clinical trial manufacture externally as well as support clinical trial material manufacture within Vertex
Coordination with other Vertex groups (such as Analytical Development, Materials Discovery and Characterization, Supply Chain Management, Quality Assurance, etc.) to ensure that Clinical Trial Materials are produced in a timely manner
Contribute to drafting regulatory filing documentation
Comply with all relevant Safety and GMP procedures
Knowledge and Skills:
Strong critical thinking skills
Ability to apply the principles of the basic sciences, such as physical and organic chemistry, thermodynamics, and materials science, to technical problems, using a rational, scientific approach
Strong technical writing and data analysis skills
Excellent verbal and written communication skills
Ability to work effectively and comfortably in a multi-disciplinary team under defined timelines
Excellent teamwork and organizational skills
Education and Experience:
PhD in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 0+ years experience in life sciences, engineering or academia, or
Master's Degree in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 3+ years experience in life sciences, engineering or academia, or
Bachelor's Degree in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 6+ years experience in life sciences, engineering or academia
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.