Formulation Research Scientist

Job Description

General Summary:

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 and 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

Knowledge and Skills:

• 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

Education and Experience:

• PhD in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 0-3 years experience in life sciences, engineering or academia, or
• Master's Degree in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 3 years experience in life sciences, engineering or academia, or
• Bachelor's Degree in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 6 years experience in life sciences, engineering or academia

Pay Range:

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]