GENERAL SUMMARY:

Vertex is seeking a talented individual to join our Manufacturing Science & Technology (MSAT) Small Molecule Drug Substance group in Boston, MA as a Process Chemistry Senior Scientist. A team of highly productive, results-oriented individuals, the Vertex MSAT Small Molecule Drug Substance team is responsible for building and operating the global supply network that delivers our commercial active pharmaceutical ingredient (API) 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 Scientist should possess a proficient level of cGMP drug substance manufacturing understanding from a chemistry, engineering and analytical perspective. The person 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 Scientist should work collaboratively with project stakeholders, and has the ability to understand and communicate results to effectively address project needs.

REQUIRED QUALIFICATIONS:

• Typically requires a Bachelor’s degree and 8+ years of experience or a Master’s degree and 5+ years of experience or a PhD and 2-5 years of experience, or the equivalent combination of education and experience.
• Passion for scientific knowledge
• Excellent verbal and written communication skills
• Be highly-motivated and have an excellent work ethic

REQUIRED EXPERIENCE

• Experience applying statistical approaches in the design and analysis of experiments
• Experience in scale-up/late phase clinical development and technical support in manufacturing environments
• 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
• Must be able to demonstrate core values/leadership
• Previous experience in the biotech/pharmaceutical industry is required.

• 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
• Assists in developing and executing technical transfer and process validation activities
• Provides technical support in resolving manufacturing and/or testing issues that arise
• Promotes positive and effective relationships with relevant technical individuals or teams at contract manufacturing sites
• Synthesizes or characterizes markers and reference standards when needed.
• Participates in material qualification activities and technical assessment of potential contract manufactures, including performing and/or analyzing use-tests of samples in the lab
• Contributes to generation and review of technical documentation
• Will require travel periodically to contract manufacturing plants to monitor process performance or to troubleshoot manufacturing issues in the plant
• 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 (such as 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
• Domestic and international travel (20% of time) is required to provide onsite support during manufacturing