Vertex

Biotechnology

ProcessAnalytics&ControlResearchScientist

$99–149k Boston, Massachusetts, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“Process Analytics & Control Research Scientist at Vertex. Skills: Process Analytics, Control strategy, PAT methods, Dissolution testing. Develop PAT methods. Develop data models”

Industry & Context.

Biotechnology
Problems you'll solve

Troubleshoot; Analyze data; Interpret data

What They're Looking For.

Must Have

Ph.D. in Chemistry, Chemical Engineering or Pharmaceutical Chemistry and 0-3 years’ experience, Masters and 2-5 years experience, Bachelor's degree and 6+ years of experience of relevant analytical experience, Experience with regulatory requirements and industry standards, including cGMP

Nice to Have

Expertise in both process analytics and dissolution testing

What You'll Do.

Support unit manufacturing operations

Implement PAT methods/models

Implement real time in-process controls

Implement real time release testing

Implement automated control strategies

Support continuous GMP manufacturing

Configure automated control strategies

Perform bench testing

Perform integrated script testing

Support GMP continuous manufacture

Support clinical manufacturing

Qualify PAT equipment

Maintain PAT equipment

Support analytical method development

Support analytical method validation

Support analytical method transfer

Develop analytical experiments

Troubleshoot analytical experiments

Conduct analytical experiments

Support drug substance process development

Support drug product process development

Comply with SOPs and regulations

Collate analytical data

Interpret analytical data

Compile results into conclusions

Compile results into recommendations

Guide Project decisions

Guide new analytical activities

Maintain accurate records

Demonstrate knowledge of scientific principles

Understand applicable drug development regulations

How You'll Work.

Team & Collaboration

Formulation Development team; Process Analytics and Control team; Dissolution team; Team/matrix environment

Communication Scope

Communication skills

Full Job Description

**Job Description** **Position Overview:** Vertex is seeking a talented individual to join our Formulation Development team in Boston, MA. Consistently and passionately challenging the boundaries of their knowledge, our Formulation Development team employs traditional and innovative analytical techniques and Quality-by-Design principles to ensure the safety, efficacy and quality of Vertex pharmaceutical products. This position provides a unique opportunity to contribute to drug product development in a dual role as a member of both the Process Analytics and Control team and the Dissolution team. The Process Analytics and Control team is responsible for the automated control strategy for drug product continuous manufacturing and the development/validation of PAT methods. Specific responsibilities include compliance to cGMPs, the development and validation of Process Analytical Technology (PAT) methods and data models, statistical data analysis including the justification for sampling plans, Monte Carlo simulations, etc., and the evaluation of new technology to support Formulation Development and Continuous GMP Manufacturing. As a member of the Dissolution team this role will also support the drug development programs at Vertex through analytical method development, validation, and transfer. This person will have the opportunity to develop and execute analytical strategies for phase appropriate dissolution methods and specification justifications. Applicants are not expected to have expertise in all aspects of both process analytics and dissolution testing but should have a strong background in analytical chemistry, chemical engineering, or pharmaceutical chemistry and the ability to grow and develop within the opportunities presented in this role. Both strong analytical technical capabilities and excellent communication skills are required to be successful in this role. **Key Duties and Responsibilities:** **_PAT responsibilities:_** * Developing PAT methods (multiva

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