Temporary Contract, 6 months
Vertex is seeking a Temporary Senior Scientific Associate to join our Formulation Development group in Boston, MA. Formulation Development group is a fast paced and high energy environment. We are looking for a candidate with a strong background in oral solid form development and good understanding of material properties. The candidate will work with other scientists dedicated to advance 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 candidate must be a strong team player with excellent communication skills working in a complex cross-functional matrix. The candidate must work independently and take initiative. The candidate must be intellectually curious and show resilience in solving complex problems. This candidate will show the courage to take risks and follow through to completion.
Key Responsibilities include, but are not limited to
Develop solid dosage forms for clinical and commercial use, generate data for project progression and regulatory filings, conduct optimization and scale up studies.
Help design, plan, execute, and interpret laboratory experiments, with minimal supervision, to meet established project timelines.
Maintain accurate and complete laboratory notebook capturing protocols, results and observations. Interpret data to form sound conclusions.
Timely document integrated experimental outcomes in presentations and research reports.
Perform basic statistical analysis of experimental data
Assist in technical transfer to CMO partners for clinical trial manufacture
Initiate experimental troubleshooting on a routine basis, with minimal supervision
Contribute to drafting regulatory filing documentation
Support data verification (QC checking) of data for regulatory filings
Comply with all relevant Safety and GMP procedures
The successful candidate will possess
Sound knowledge of pharmaceutical and engineering principles in the solid dosage form development for both clinical and commercial scales
Hands on experience with formulation techniques, processing equipment, and unit operations at both the laboratory and clinical manufacturing scales.
Strong math skills particularly as applied to material/energy balances, and intermediate applied statistical analysis
Strong technical writing skills
Excellent verbal and written communication skills
Successful and efficient multitasking and working on a few projects concurrently
Direct experience working with CMOs is a plus
Understanding of QbD and experience with regulatory filings is a plus
Vertex Pharmaceuticals, Inc