Senior Manager, Analytical Technical Operations
Vertex Pharmaceuticals Inc. is looking to hire a Senior Manager, Analytical Technical Operations to join the Technical Operations group in Boston, MA. Vertex is seeking a talented, experienced process analytical chemist. 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 products utilizing PAT(Process Analytical Technology). You will be part of an organization that thrives on innovation and is at the forefront of implementing Quality by Design and Continuous Manufacturing.
Spectroscopic method validation/implementation/revalidation and model maintenance (in house and working with CMO/CRO)
Experimental design to support new product commercialization and root cause analysis for existing products
On-going support of commercial manufacturing activities utilizing continuous manufacturing processes and real-time release testing
Data collection, interpretation, trending, and report generation
Method transfers to new CMOs and analytical support for second-source activities
Ph.D. plus 4 years of direct work experience in the Biotech/Pharmaceutical industry
Experience in an analytical development role, supporting new product development and commercialization and problem-solving/root cause analysis
Fluent and experienced in spectroscopic method development (NIR, Mid-IR, Raman, laser diffraction)
To be considered for this position the applicant will need to be a collaborative, experienced and competent spectroscopist with a history of developing, implementing and troubleshooting new spectroscopic methods and technologies in the pharmaceutical industry, with the ability to influence colleagues, and possessing strong communication and negotiation skills.
Understanding of physical characterization method development (XRPD, laser diffraction, vision analysis, powder flow analysis, etc)
Experienced with chemometrics and multivariate modeling across spectroscopic techniques
Familiar with pharmaceutical manufacturing operations and online PAT measurements
High emotional intelligence and strong negotiating skills
Strong communication and technical writing skills are required
Experience supporting commercial drug product analytical development activities
Background in using analytical measurement systems to support development or to find root cause of manufacturing issues
Experience in using on-line and at-line measurements to support QbD and on-going Continuous Improvement
Working knowledge of plant engineering (standards and systems)
Software expertise in Unscrambler, Matlab, JMP, OPUS, TQAnalyst, Vision, RTSizer, Holograms, and icRaman
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, please visit www.vrtx.com.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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