Formulation Research Scientist (Contract) 26096

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 & 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

Required Experience

• Typically requires a PhD in pharmaceutical sciences chemistry chemical engineering materials
  sciences or related field and 0-3 years experience in life sciences engineering or academia or aMasters Degree in pharmaceutical sciences chemistry chemical
  engineering materials sciences or related field and 3 years experience in life sciences
  engineering or academia or a Bachelors Degree in pharmaceutical sciences chemistry chemical
  engineering materials sciences or related field and 6 years experience in life sciences
  engineering or academia
• Expanded conceptual 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 and data analysis skills
• Excellent verbal and written communication skills
• Strong background in physical chemistry and good understanding of material properties
• 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
• Ability to work effectively and comfortably in a multi-disciplinary team under defined timelines
• Excellent teamwork and organizational skills
• GLP GMP and GxP experience

$60-$72/hr

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (Vertex). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors including skills competencies experience location and/or being pursued and other job-related factors permitted by addition this role will be eligible for overtime pay in accordance with federal and state requirements

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