Principal Process Engineer

General Summary:

The incumbent will work cross-functionally with colleagues in the BSMO/CMSC, Regulatory, Quality and R&D of Vertex on the design of processes and technologies required to successfully commercialize an exciting and diverse portfolio of innovative pipeline programs. The Process Development Engineering Principal Scientist will be part of a team working to design and develop robust, scalable, well characterized, and economical upstream processes for clinical and commercial manufacturing of biologics. The successful candidate will interact with internal product development groups and with Vertex's network of external CMOs/contract labs.

Key Duties and Responsibilities:

Apply a demonstrated understanding of mammalian cell culture operations to support technology transfer and scale-up of clinical/commercial manufacturing processes.

Use comprehensive understanding of chemical engineering principles for the scale up of unit operations from bench to commercial scale.

Be a technical leader in solving clinical and commercial drug substance process issues involving equipment, scale, and raw materials. Evaluate process capabilities to develop and implement process and yield improvement opportunities.

Provide floor support/person-in-plant for manufacturing activities during development and GMP campaigns (travel will be required).

Use Design of Experiments (DOE) with subsequent statistical analysis of data to establish robust process models, parameters and specifications.

Applies QbD principals to process characterization, establish process parameters, and contribute to CMC sections of regulatory filings

Perform process/product risk assessments (FMEA, QbD) and prepare relevant reports.

Provide content and author relevant sections in regulatory submissions.

Represent Upstream on one or more internal project teams and on CMO/external project teams to enable successful project deliverables.

Collaborate within CMC teams as an Upstream SME and actively contribute to deliverables and engage in team discussion on issue resolution.

Mentor and train junior scientists and engineers, fostering a collaborative and innovative work environment.

Troubleshoots and leads others to troubleshoot and resolve complex process challenges by taking a new perspective on solutions or developing develop novel solutions

Knowledge and Skills:

*Strong fundamental knowledge and subject matter expertise in cell-culture process development for biologics, fed-batch cell culture, bioreactor scale-up and scale-down, as well as recent advances, and challenges in the field.

*Experience with intensified fed-batch and/or perfusion process development and associated process-analytical technologies is preferred.

*Strong familiarity with JMP preferred.

*Experience with risk assessments, root cause analysis and deviation management.

*A proven ability to work seamlessly across teams and develop excellent relationship and partnerships with peers is critical to success in this role.

*Demonstrated understanding of the principles and applications associated with commercial manufacturing operations.

*Strong understanding of the technical aspects of manufacturing, testing, and controls and regulations governing pharmaceutical operations.

*Strong knowledge of cGMP requirements.

*A strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner.

* Excellent communication and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues and concepts enterprise-wide.

* Excellent team player and be able to build and sustain organization respect and trust at all levels.

* Problem solver with a hands-on approach and ability to a