Chemistry Manufacturing Controls Manager

Vertex Pharmaceuticals; Boston (MA); Hybrid; USD 103,000 - 155,000; Full time

Benefits offered by this job

Hybrid work flexibility

On-site option

Job summary

Vertex Pharmaceuticals Incorporated in Boston is seeking a Chemistry Manufacturing Controls Manager to lead regulatory CMC activities for investigational and commercial products.

You will review CMC submissions, develop global regulatory CMC strategies, and serve as the primary CMC contact for assigned programs, coordinating with cross-functional teams and Health Authorities. A hybrid work arrangement is available, with on-site responsibilities and a strong total rewards program.

Qualifications

• Bachelor's degree in Chemistry, Biology, Regulatory Affairs, or a related field.
• 4+ years of experience in CMC or regulatory affairs.
• Experience supporting regulatory inspections and audits.
• Familiarity with FDA, EMA and ICH guidelines.
• Experience with regulatory submissions writing.

Responsibilities

• Review CMC sections of regulatory submissions and agency interactions.
• Develop global regulatory CMC strategies for investigational and commercial products.
• Collaborate with regulatory teams to prepare global CMC submissions.
• Provide regulatory CMC guidance to cross-functional teams.
• Influence change controls, deviations, and GMP investigations.
• Serve as primary regulatory CMC contact for assigned products.
• Contribute to preparation and submission of regulatory CMC documentation.
• Interact with Health Authorities on CMC topics.

Skills

Regulatory knowledge

CMC submissions

Cross-functional collaboration

Education

Bachelor's degree in Chemistry, Biology, Regulatory Affairs, or related field

Tools

Veeva

Job description

Job Description

Employer: Vertex Pharmaceuticals Incorporated

Job Title: Chemistry Manufacturing Controls Manager

Job Location: 50 Northern Ave., Boston, Massachusetts 02210

Openings: 1

Job Type: Full Time

Duties

• Review chemistry manufacturing control (CMC) sections of regulatory submissions, as well as the interactions and responses with regulatory agencies.
• Contribute to the development of global regulatory CMC strategies for investigational and commercial products.
• Work with regulatory colleagues in development of global regulatory CMC strategies and submissions.
• Provide regulatory CMC guidance to cross-functional teams and key stakeholders.
• Influence regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations.
• Participate effectively on cross-functional teams and serve as the primary regulatory CMC contact for assigned products and projects.
• Influence the execution of multi-product global regulatory CMC strategies for investigational and marketed products.
• Contribute to the preparation and submission of regulatory CMC documentation and interact with Health Authorities for CMC topics.
• Provide regulatory support and guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial programs.

Telecommuting permitted up to 40%.

Requirements

Employer will accept a Bachelor’s degree in Chemistry, Biology, Regulatory Affairs, or a related field and 4 years of experience in the job offered or in Chemistry Manufacturing Controls Manager-related occupation.

Position Requires Demonstrable Experience In The Following

• Preparation, including writing, of chemistry manufacturing control (CMC) submissions for both investigational and marketed products.
• Demonstrated ability to assess post approval change for regulatory impact in global markets.
• Experience in supporting regulatory inspections, audits, and inspection readiness activities from a CMC documentation and compliance perspective.
• Demonstrated experience utilizing web-based publishing software, including Veeva, to facilitate regulatory submissions.
• Sound knowledge of current Good Manufacturing Practice (cGMP) regulations and global regulatory frameworks including Federal Drug Administration (FDA), European Medicines Agency (EMA), and International Council for Harmonization of Technical Requirements for Human Use (ICH) for investigational and marketed products.
• Evaluation of development and commercial change controls to identify any GMP-related changes that may impact regulatory applications.

Telecommuting permitted up to 40%.

Rate of Pay

$103200.00- $154800.00

Pay Range

$0 - $0

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

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status

• Hybrid: work remotely up to two days per week; or select
• On-Site: work five days per week on-site with ad hoc flexibility.

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]