Vertex
Chemistry Manufacturing Controls Senior Specialist
Vertex, Boston, Massachusetts, United States, 02108
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% Pay Range: $100,000 - $150,000 Flex Designation: Hybrid-Eligible or On-Site Eligible 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. 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.
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% Pay Range: $100,000 - $150,000 Flex Designation: Hybrid-Eligible or On-Site Eligible 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. 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.