Associate Director, Analytical Development
Vertex is seeking a talented individual to join our Analytical Development group in Boston, MA. As an experienced member of the Analytical Development team, this role will supervise and organize a variety of scientific functions encompassing small molecule Drug Substance and Drug Product development, and will provide day to day leadership for specific projects assigned. Knowledge of cGMPs and Regulatory guidelines is required. Mentorship of junior technical staff is expected, with particular focus on HPLC and GC. The ability to work both independently and in a matrix team environment is essential.
• Oversees and coordinates aspects of product and analytical method development
• Defines, develops and conducts experiments that are in compliance with applicable regulations and SOPs
• Interfaces with CROs to transfer methods and is a point of contact for investigations and other product development activities
• Performs overall review of data generated on development and clinical supply samples
• Develops, reviews and approves source documents for regulatory submissions
• Authors, reviews, and approves SOPs, analytical methods, protocols, and reports
• Mentors and supervises staff and is responsible for the quality and accuracy of the work done by others. Presents to cross functional teams and effectively communicates critical issues and solutions to staff at all levels within the organization. Technical expert for data review and interpretation
• A Ph. D. or Master's in Analytical Chemistry.
• 10+ years (PhD) or 13+ years (MS) within the Pharmaceutical Industry.
• Strong skills in Analytical chemistry are required.
• An in-depth knowledge of HPLC and GC, including both theory and practice is required.
• The ability to work successfully in both a team/matrix environment as well as independently is essential.
• The ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects is essential.
• Excellent written and verbal communication skills as demonstrated by symposia presentations and research publications in peer reviewed journals are required.
• Knowledge of cGMPs, Regulatory guidelines and additional analytical techniques (MS, KF, dissolution) are desirable.
• Limited travel is required. An ability to travel 10% is a requirement.
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 ***************@vrtx.com.
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