Vertex is seeking a talented individual to join our Formulation Development group in Cambridge, MA.
Through the design and execution of experimental programs to optimize and scale-up clinical formulations, the Formulation Development group achieves its objective of manufacturing clinical trial materials to support first in man through to pivotal clinical trials. As a member of the Formulation team, this role will support Vertex's drug development programs through the development and scale-up of clinical and commercial formulations in a Quality by Design (QbD) environment.
Key Responsibilities include but are not limited to:
- Design, execute, analyze, and present experiments/results toward developing early phase (PhI, II, POC) clinical (and future commercial) formulations
- Development of stable solution/suspension based formulations for poorly soluble drugs and transfer of documented preparation instructions to contract research sites
- Development of amorphous pharmaceutical systems into solid oral dosage forms
- Oversight of scale-up and technology transfer to contract manufacturing sites
- Collaboratively working with CROs/CMOs to outsource formulation development and external scientific research as needed
- Coordination with other Vertex groups (Analytical Development [AD], Materials Discovery and Characterization [MDC], Supply Chain Management [SCM], Chemical Development [CD], Quality Assurance [QA]) to ensure that Clinical Trial Materials are produced in a timely manner
- A PhD or MS degree with a life science concentration (educational concentrations in chemistry, pharmaceutics or engineering preferred)
- 0 -3 (PhD) or 3+ (MS) years pharmaceutical industry experience
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases. Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science Magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist, and most recently was named the top employer in Science magazine's 2011 annual survey. For more information and to view Vertex's press releases, please visit www.vrtx.com.
- Experience working with small molecule new chemical entities (NCEs) and exposure to early phase formulation development activities
- Experience with a range of dosage forms, including liquids, solids and oral. Experience with formulation development of poorly soluble compounds would be advantageous
- Proven experience managing the scale-up and manufacturing of solid oral dosage forms
- Proven ability to apply the principles of the basic sciences, such as physical and organic chemistry, thermodynamics, and materials science, to preformulation and formulation development, using a rational, scientific approach.
- A history of success working in environments defined by innovation and initiative
- Ability to work effectively and comfortably in a multi-disciplinary team under defined timelines
- Excellent leadership, teamwork and organizational skills
- Solid verbal and written communication skills
- Can do attitude
- GLP, GMP, cGxP experience
- Strong data analysis skills
VERTEX is an Equal Employment Opportunity/Affirmative Action employer. All employment decisions are made without regard to race, sex, national origin, color, religion, age, disability, veteran status, genetic information or any other status protected by federal, state or local law.
Vertex Pharmaceuticals aims to cure patients with previously incurable diseases. The biotechnology company uses an integrated,...