Job Description

General Summary:

The Process Engineering Manager delivers reliably and responsibly on independent activities and is responsible for execution and oversight of internal or external manufacturing operations in a technical area. The incumbent is a key participant on internal and external cross-functional teams within their technical area for one or more supplier(s). The role assists in maintaining effective interactions with suppliers and other key stakeholders.

In this Hybrid-Eligible role, you can choose to be designated as:

Hybrid: work remotely up to two days per week;

or select On-Site: work five days per week on-site with ad hoc flexibility.

Key Duties and Responsibilities:

• Recognized as a subject matter expert and acts as a resource in their technical area

• Evaluates process performance using statistical process controls to identify and lead continuous improvement activities throughout the product lifecycle

• Works effectively with CMC stakeholders to deliver projects on time

• Assists in maintaining effective relationships between Vertex and key suppliers of materials, technology, and manufacturing resource

• Evaluates process performance using statistical process controls to identify and lead continuous improvement activities

• Resolves complex manufacturing issues and supports resolution of quality investigations

Knowledge and Skills:

• Advanced knowledge of GMP's and associated CMC regulatory considerations in a pharmaceutical environment

• Demonstrated experience managing projects in the pharmaceutical industry

• Fundamental understanding and application of technology transfer and validation processes

• Solid communication, collaboration and team building skills; ability to connect with all levels of the organization

• Demonstrated ability to manage multiple projects concurrently, and flexibility to accommodate changes in responsibilities or project priorities

• Experience with commercial manufacturing of spray dried dispersion and/or oral solid dosage forms

• Familiarity with complex data analysis, mathematical modeling and optimization software (like Matlab, JMP, etc.)

• Knowledgeable inQbDand designed experiment methodology and implementation

• Ability to travel domestically and internationally. (Approximately 30%)

Education and Experience:

• Bachelor's degree in pharmaceutical sciences or engineering discipline
• Requires the following combination of education and experience, PhD and 2+ years, or Master's and 5+ years, or Bachelor's and 8+ years.

Company Information