Analytical Chemistry Manager
Analytical Chemistry Manager
Vertex is seeking a talented, experienced analytical chemist for late-stage product development in a commercial setting. Working directly with our contract manufacturing organizations and a highly diverse group of scientists at Vertex you will solve complex problems encountered in commercial production/manufacturing of drug substances. You will be part of an organization that thrives on innovation and is at the forefront of implementing Quality by Design and Continuous Manufacturing.
To be considered for this position the applicant will need to be a collaborative, experienced and competent analytical chemist with a history of developing, implementing and troubleshooting analytical methods in the pharmaceutical industry, with the ability to influence colleagues, and possessing strong communication and negotiation skills.
Method transfers for small molecule drug substance to various CMOs or between internal groups
Method validation or co-validation to support late-phase and commercial projects
Authoring/reviewing documentation to support new and existing commercial products (methods, SOPs, transfer protocols/reports, lab notebooks, technical reports, etc.)
Independently managing CMOs for manufacturing of GMP starting materials, intermediates and drug substances, leading analytical OOS/OOT investigations/assisting process investigations and providing scientific-sound solutions to root cause identification of quality events
Reviewing CMO’s analytical raw data and result reports including both release and stability data
Commercial data collection, interpretation, reviewing, trending, and report generation to support continuous process verification
Continuous method improvement through commercial change control procedures
BS/MS with 5+ years or Ph.D. with 2+ years of relevant pharmaceutical experience
Experience with small-molecule drug substance IPC, release and stability methods
Experience in an analytical development or technical operations role, supporting new product development and commercialization.
Experience with chromatography methods such as HPLC, GC, and other common analytical techniques used in pharmaceutical analysis
Experience with compendial methods for analysis (e.g. KF, elemental impurity testing, and identification by spectroscopy)
Knowledge of cGMP’s (e.g. Quality Control), ICH guidelines and associated CMC regulatory considerations in a pharmaceutical setting
Strong communication and technical writing skills
Must be a committed team player and collaborator
Background and knowledge of process chemistry, in support of process development and process validation
Experience supporting development activities and trouble-shooting manufacturing issues using various analytical techniques
Knowledge of DoE and QbD tools for process development and characterization
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.