Cmc Chemistry Manufacturing Control Jobs (NOW HIRING)

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%

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• 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

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: 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

#LI-Hybrid

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

Help Us Achieve Our Mission

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.