Senior Technical Specialist (Drug Substance Manufacturing)

Vertex Pharmaceuticals Inc (US) Boston, MA

About the Job

Vertex is seeking a talented individual to join our Technical Operations group in Boston, MA as a Senior Technical Specialist. A team of highly productive, results-oriented individuals, the Vertex Technical Operations team is responsible for building and operating the global supply network that delivers our commercial active pharmaceutical ingredient (API) and drug product (DP) to ensure uninterrupted treatment to patients. An exceptional chemical, analytical and engineering technical aptitude, as well as managerial excellence is required for successful execution of our responsibilities.  Solving difficult logistical challenges, technical problems and building collaborative cross-functional relationships are all key to our success.

The Senior Technical Specialist should possess a proficient level of cGMP drug substance manufacturing understanding from an organic chemistry, engineering and analytical perspective. The Senior Technical Specialist is a key technical resource, utilizing their chemistry/engineering expertise and laboratory skills to resolve production issues and continuously improve the manufacturing process and/or analytical methods. The Senior Technical Specialist should work collaboratively with project stakeholders and has the ability to understand and communicate results to effectively address project needs.

Key responsibilities and Technical Skills for this role include:

  • Conducts/designs and interprets chemical, engineering and analytical experimental procedures in the laboratory both independently or following direction from supervisor/mentor, and according to established safety guidelines
  • Provides technical support in resolving manufacturing and/or analytical testing issues that arise
  • Develops strong working relationships with relevant technical individuals or teams at external contract manufacturing sites
  • Synthesizes or characterizes markers and reference standards as required.
  • Performs and/or analyzes use-tests of samples in the lab to support qualification of new materials and suppliers
  • Will require travel periodically to contract manufacturing plants to monitor process performance or to troubleshoot manufacturing issues
  • Complies with all Quality, Regulatory, Health, Safety, and Environmental responsibilities for the position
  • Takes full responsibility within scope of the position to work with various stakeholders (Quality, Supply Ops, Regulatory, Pharm Dev, suppliers, etc.) to proactively and collaboratively resolve issues that may negatively impact project timelines or deliverables
  • Proactively communicates technical and operational trends orally to supervisor/team and through written reports and oral presentation
  • Performs other duties as assigned

Minimum Requirements:

  • MS/BS in Chemistry/Chemical Engineering or similar field
  • Hands-on Laboratory experience preferred
  • Passion for scientific knowledge
  • Excellent verbal and written communication skills
  • Be highly motivated and have an excellent work ethic
  • Experience applying statistical approaches in the design and analysis of experiments
  • Demonstrated ability to develop solutions to complex, open-ended problems with creativity and innovation
  • Ability to multi-task and complete work in a reliable and consistent manner
  • Appropriate computer skills to support instrumentation and data manipulation
  • Ability to travel up to 10% of time (including internationally)