- Salary
- $103k – $155k
- Location
- 5000 - Vertex US - Fan Pier, United States of America
- Type
- Full-time
- Department
- Manufacturing
- Seniority
- Manager
- Experience
- 4+ years
- Closing date
- Today
- Source
- Workday
Description
Job Description
This notice is being provided as a result of the filing of an application for permanent alien labor certification for the below job opportunity. Any person may provide documentary evidence bearing on the application to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue NW, Room N–5311, Washington, DC 20210. Phone (202) 693-2991.
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:
1. Preparation, including writing, of chemistry manufacturing control (CMC) submissions for both investigational and marketed products.
2. Demonstrated ability to assess post approval change for regulatory impact in global markets.
3. Experience in supporting regulatory inspections, audits, and inspection readiness activities from a CMC documentation and compliance perspective.
4. Demonstrated experience utilizing web-based publishing software, including Veeva, to facilitate regulatory submissions.
5. 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.
6. 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
CONTACT: Send Resume to [email protected]. Reference 12140.764. EOE.
Pay Range:
$0 - $0Disclosure 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 EligibleFlex 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.
#LI-Hybrid
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 [email protected]
