Job Description

JOB TITLE: Chemistry Manufacturing Controls Senior Specialist

LOCATION: 50 Northern Ave., Boston, MA, 02116

OPENINGS: 1

DUTIES:

• Prepares CMC documents and Health Authority submissions (investigational stage, marketing applications, and post approval), as well as for interactions with and responses to Health Authorities.

• Assists with the development of global regulatory CMC strategies for investigational and marketed products.

• Assists with providing regulatory CMC guidance to cross-functional teams and key stakeholders.

• Contributes to the regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations.

• Supports cross-functional teams effectively and supports the primary regulatory CMC contact for assigned products and projects.

Telecommuting permitted up to 40%

REQUIREMENTS: Employer will accept a Bachelor's degree in Chemistry, Biology or equivalent or a related field and 2 years of experience in the job offered or in a Chemistry Manufacturing Controls Senior Specialist-related occupation.

Position requires demonstrable experience in the following:

Preparing CMC documentation for Health Authority submissions (investigational stage) as well as fundamental understanding of post approval change management;

Developing regulatory CMC strategies for investigational and marketed products;

Thorough understanding of GMPs and the development of investigational drugs;

Evaluate development and commercial change controls to identify any GMP-related changes that may impact regulatory applications; and;

When applicable, lead the revision of affected documentation and ensure all materials are prepared in compliance with the relevant regulatory authorities

Telecommuting permitted up to 40%

Rate of Pay: $100000.00 - $150000.00

CONTACT: Send Resume to Ken Strecker at Ken_Strecker@vrtx.com. Reference 12140.764. EOE.

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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 Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: 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