Formulation Scientist Continuous Manufacturing
Company: Vertex Pharmaceuticals
Location: Boston
Posted on: October 12, 2024
Job Description:
Formulation Scientist Continuous Manufacturing
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 processes.
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
Flex Designation:
On-Site Designated
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.
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 ApplicationAssistance@vrtx.com
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Keywords: Vertex Pharmaceuticals, Revere , Formulation Scientist Continuous Manufacturing, Other , Boston, Massachusetts
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