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Senior Manager, Technical Operations (Analytical) at Vertex

Employer
Vertex Pharmaceuticals
Location
Boston, Massachusetts
Start date
Feb 26, 2019

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. 

Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and offices around the world. For several consecutive years, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit www.vrtx.com. 

 

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 successful in this position you 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. You will have the ability to influence colleagues, and possess strong leadership, communication and negotiation skills.

Key Responsibilities

  • 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 and drug substances, leading analytical OOS/OOT investigations and assisting process investigations
  • 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
  •   Minimum Qualifications
     
  • 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
  • Problem-solving/root cause analysis for analytical related issues
  • Experience with chromatography methods such as HPLC, GC, and other common analytical techniques used in pharmaceutical analysis
  • 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
  • Committed teammate and collaborator
  • Preferred Qualifications:
  • Experience with compendial methods for analysis (e.g. KF, elemental impurity testing, and identification by spectroscopy)
  • 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 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.

 

 

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