Formulation Senior Research Associate

Vertex Pharmaceuticals Incorporated; Boston (MA); On-site; USD 74,000 - 111,000; Full time

Job summary

Vertex Pharmaceuticals Incorporated is seeking a Formulation Senior Research Associate to advance drug candidates from exploratory development through commercial lines in a QbD setting. You will work with scientists to develop solid dosage forms for clinical and commercial use and generate data for project progression and regulatory filings.

Responsibilities include executing experiments, maintaining notebooks, interpreting data, documenting outcomes, and assisting in tech transfer to CMOs.

Qualifications

• Bachelor's degree in pharmaceutical, materials science or chemical engineering.
• Master’s in pharmaceutical sciences, chemistry, chemical engineering, or materials science with 0–2 years.
• Bachelor’s in pharmaceutical sciences, chemistry, chemical engineering, or materials science with 4 years.
• Solid dosage form development experience.
• Regulatory filing familiarity is a plus.

Responsibilities

• Develop solid dosage forms for clinical and commercial use, generate data for project progression and filings.
• Execute and interpret laboratory experiments with minimal supervision to meet timelines.
• Maintain accurate laboratory notebooks capturing protocols, results and observations.
• Interpret data to form sound conclusions.
• Document integrated experimental outcomes in presentations and research reports.
• Perform basic statistical analysis of experimental data.
• Assist in technical transfer to CMOs for clinical trial manufacture.
• Initiate troubleshooting on routine problems with minimal supervision.
• Contribute to drafting regulatory filing documentation.
• Comply with Safety and GMP procedures.

Skills

Pharma principles

Formulation techniques

Statistical analysis

Technical writing

Communication skills

Multitasking

Detail-oriented

CMO collaboration

QbD understanding

Oral solid form

Education

Bachelor's degree in pharmaceutical, materials science or chemical engineering

Master’s in pharmaceutical sciences, chemistry, chemical engineering, or materials science (0-2 years)

Bachelor’s in pharmaceutical sciences, chemistry, chemical engineering, or materials science (4 years)

Job description

Job Description

General Summary

The Formulation Senior Research Associate will perform an array of activities working with other scientists to advance drug candidates from exploratory development through commercial line extension in a Quality by Design (QbD) environment using lab based and computational tools.

Key Duties and Responsibilities

• Contribute to the development of solid dosage forms for clinical and commercial use, generate data for project progression and regulatory filings, conduct a range of activities for optimization and scale up studies
• Help execute, and interpret laboratory experiments, with minimal supervision, to meet established project timelines
• Maintain accurate and complete laboratory notebook capturing protocols, results and observations
• Interpret data to form sound conclusions
• Timely document integrated experimental outcomes in presentations and research reports
• Perform basic statistical analysis of experimental data
• Assist in technical transfer to CMO partners for clinical trial manufacture
• Initiate experimental troubleshooting on routine problems, with minimal supervision
• Contribute to drafting regulatory filing documentation
• Comply with all relevant Safety and GMP procedures

Knowledge and Skills

• Sound technical 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
• Strong verbal and written communication skills
• Successful and efficient multitasking and ability to work on a few projects concurrently
• Detail-oriented
• Direct experience working with CMOs is a plus
• Understanding of QbD and experience with Regulatory filings is a plus
• Strong background in oral solid form development and good understanding of material properties

Education and Experience

• Bachelor's degree in pharmaceutical, material science or chemical engineering field
• Master's Degree in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 0-2 years experience in life sciences, engineering or academia, or
• Bachelor's Degree in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 4 years experience in life sciences, engineering or academia

Pay Range

$74,000 - $111,000

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

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.

#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 [e-mail]