Chemistry Manufacturing Controls Senior Specialist

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:

$100,000 - $150,000

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.

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