Please contact your Administrator to change your authorization settings.
Job Description
General Summary:
The Process Engineering Senior Manager role delivers on complex manufacturing activities in a technical area and is responsible for ensuring effective relationships with all stakeholders. The role is responsible for successful process validation and commercial manufacturing, drives resolution of complex manufacturing issues. The successful candidate will champion high-impact cross-functional initiatives and maintain strong relationships with key internal and external stakeholders. This role requires proven experience in a cGMP environment, a broad understanding of the interaction between technical, regulatory, and business challenges, and strong scientific/engineering skills in order to drive continuous improvement initiatives in a global, post-approval environment.
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:
- Acts as a resource in one or more technical areas and may lead small projects
- Contributes to the development of tools and standards for department functions
- Represents department on cross-functional CMC teams to influence late stage process/product development and minimize subsequent commercialization risk
- Develops and executes manufacturing strategies for Technology Transfers and Process Validations, including formulation of strategic master plans, protocols and reports
- Takes full responsibility within scope of the position to work with various stakeholders (such as Quality, Supply Ops, Regulatory, Development, CDMOs, etc.) to proactively and collaboratively resolve issues that may negatively impact project timelines or deliverables
- Ensures effective relationships with key suppliers of materials, technology, and manufacturing resources
- Evaluates process performance using statistical process controls to identify and lead continuous improvement activities throughout the product lifecycle
- Resolves complex manufacturing issues by taking a new perspective on existing solutions and supports resolution of quality investigations
Knowledge and Skills:
- Advanced knowledge of GMP's and associated CMC regulatory considerations in a pharmaceutical environment
- Experience with commercial manufacturing of spray dried dispersion and/or oral solid dosage forms
- Knowledgeable in QbD and designed experiment methodology and implementation
- Experience managing projects in the pharmaceutical industry
- Strong understanding and application of technology transfer and validation processes
- Strong communication, collaboration and team building skills; ability to connect with all levels of the organization
- Ability to manage multiple high-priority projects concurrently, and influence in a strong-matrix work environment
- Mastery with complex data analysis, mathematical modeling and optimization software (like Matlab, JMP, etc.)
- 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 4+ years, or Master's and 7+ years, or Bachelor's and 10+ years.
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.
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 Human Resources at ApplicationAssistance@vrtx.com.