Manager, Technical Operations (Drug Product Manufacturing)

Job Description

General Summary:

The Manufacturing Science & Technology (MSAT) Drug Product team is responsible for managing small molecule drug product from new product launch through commercial production. This involves commercial process validations, technology transfers as well as being accountable for commercial production. Vertex manages its portfolio of products using both internal and external manufacturing options, meaning the position involves collaboration across different disciplines and organizations.

This is a Boston based hybrid position (3 days/week onsite).

Key Duties and Responsibilities:

• Recognized as a subject matter expert and acts as a resource in one or more technical areas
• Represents department on cross-functional CMC teams, with minimal guidance, 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
• Ensures positive and 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 and supports resolution of quality investigations and implement corrective actions related to tech transfer and commercial manufacturing
• Ensure risk-based process improvements, driving efficiency and cost-effectiveness while maintaining compliance
• Drive a culture of technical excellence, problem-solving, and continuous improvement; participate in technical team discussions, contributing to long term technical strategy beyond MSAT responsibilities
• Prepare for and support regulatory submissions and inspections with global health authorities

Knowledge and Skills:

• Demonstrated experience with oral solid dosage form and/or commercial spray drying
• Advanced knowledge of GMP's and associated CMC regulatory considerations in a pharmaceutical environment
• Demonstrated 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
• Demonstrated 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.)
• Knowledgeable in QbD and designed experiment methodology and implementation
• Polished written and verbal communications skills
• Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
• Willingness and 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 3+ years, or Bachelor's and 5+ years.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

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