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:
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
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.