- Vertex Pharmaceuticals
- $98,855.00 -149,600.00/year*
Healthcare - Allied Health
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.
We are looking for a candidate with a strong background in physical chemistry 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 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 be able to 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.
* 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.)
* Design, execute, analyze, and present experiments/results toward developing clinical and commercial formulations
* 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
The successful candidate will have:
* 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
* PhD or MS degree in a pharmaceutical or engineering field, material science or chemical engineering preferred, or a degree in a related physical science field with similar core course requirements
* 0 -3 (PhD) or 3+ (MS) years pharmaceutical industry experience
* Direct experience working with CMOs is a plus
* Understanding of QbD and experience with regulatory filings is a plus
* 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, GxP experience
* Strong data analysis skills
Associated topics: blood collection, laboratory, medical laboratory science, medical technologist, microbiology, pathology, sample collection, sterile processing technician, technician i, technician lab
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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