Looking for opportunities with purpose, impact and possibilities? Our client, Vertex, is a global biotechnology company that invests in scientific innovation. As they grow their pipeline at pace, they are strengthening their reputation for creating transformative medicines for people with serious diseases.
The Formulation Research Associate will perform an array of activities working with other scientists to advance drug candidates from exploratory development through commercial line extension in a Quality by Design (QbD) environment using lab based and computational tools.
Key Duties and Responsibilities:
* Contribute to the development of solid dosage forms for clinical and commercial use, generate data for project progression and regulatory filings, conduct a range of activities for optimization and scale up studies
* Help 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 routine problems, with minimal supervision
* Contribute to drafting regulatory filing documentation
* Comply with all relevant Safety and GMP procedures
Knowledge and Skills:
* Sound technical 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
* Strong verbal and written communication skills
* Successful and efficient multitasking and ability to work on a few projects concurrently
* Detail-oriented
* Direct experience working with CMOs is a plus
* Understanding of QbD and experience with Regulatory filings is a plus
* Strong background in oral solid form development and good understanding of material properties
Education and Experience:
* Bachelor’s degree in pharmaceutical, material science or chemical engineering field
* Typically requires a Master's Degree in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 0-2 years experience in life sciences, engineering or academia, or
* Typically requires a Bachelor's Degree in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 4 years experience in life sciences, engineering or academia
Vertex is partnering with Talent Works to manage their international temporary job openings. If you are successful in your application, you will be employed by Talent Works to work on a temporary assignment at Vertex.