Job Description: : Vertex Pharmaceuticals is seeking a talented employee to join our Analytical Development group in Boston, MA. Consistently and passionately challenging the boundaries of their knowledge, our Analytical Development team employs traditional and innovative analytical techniques and Quality-by-Design principles to develop and validate the analytical tools used to ensure the safety, efficacy and quality of Vertex pharmaceutical products. As a member of the Analytical Development team, the ideal candidate will have proven experience in reviewing analytical data and writing technical reports, protocols, guidelines to support cGMP and CMC regulatory submissions as well as managing GMP sample receipt and distribution with the ability to excel in a fast paced environment. Key Responsibilities: * Perform cGMP and development analytical data verification for analytical techniques that include: HPLC, GC, KF, TOC, IR, XRPD and PSD * Compile and summarize analytical data in various physical and electronic report formats. * Review laboratory equipment logbooks for adherence to SOPs * Track progress of analytical testing internally or at CMOs and summarize results, as appropriate. * Verify analytical sections for regulatory submissions * Author technical reports to summarize studies, release, and stability data * Maintain cGMP training compliance * Manage GMP sample receipt and distribution for the AD function * Occasionally perform laboratory work as required by demand * Performs other duties as assigned Qualification: * Bachelor's degree in Chemistry, Chemical Engineering or Pharmaceutical Chemistry and 0-2 years relevant analytical experience * Ability to independently review laboratory reports and analytical methods * Excellent experimental documentation is required Preferred Qualifications: * A basic knowledge of cGMPs is preferred * Knowledge of Analytical techniques such as: HPLC, GC, TOC, IR, XRD, PSD, and KF * One year of QC/data review experience * Technical knowledge and understanding of laboratory procedures, methodology and standards * Ability to independently review laboratory reports and analytical methods * Ability to provide clear and concise feedback and/or documentation of results * Strong communication skills with the ability to work in a collaborative team environment * Ability to write clear and concise technical documents * Proficient in Microsoft applications (Word, Excel, PowerPoint) and familiarity with other productivity suites such as Sharepoint and Kiteworks * Must be detail oriented and able to deal with multiple and changing priorities * Some experience with laboratory work is preferred * The ability to work successfully in both a team/matrix environment as well as an independent contributor * The ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects Associated topics: aseptic technique, biopharmaceutical, drug discovery, healthcare, nutritionist, pharmaceutical, pharmacology, physiologist, toxicologist, trauma
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.