Job Description
General Summary:
The Package Engineering Senior Manager is an emerging professional within the department. This role delivers on complex outsourced manufacturing activities in Packaging and is responsible for ensuring positive and effective relationships with all stakeholders. This role will focus primarily on commercializing biologics, cell & gene therapy products and preparing pipeline products for launches across a global network.
Key Duties and Responsibilities:
- Represents department on cross-functional CMC sub-teams, with minimal guidance
- Ensures positive and effective relationships with key suppliers of materials, technology, and manufacturing resources
- Manages and designs key packaging activities including packaging design and specification, equipment and tooling design and qualification, labeling, material selection, testing, and sourcing
- Works effectively with multiple stakeholders including Pharmaceutical Sciences, Manufacturing Sciences & Technology, Regulatory Affairs, Project Management, Supply Chain, Quality, and Marketing to meet project timelines and objectives
- Reviews process performance to identify continuous improvement activities for commercial products
- Supports resolution of quality investigations
- May lead technical transfer and process validation activities; responsible for authoring and reviewing packaging qualification and validation documents.
Knowledge and Skills:
- Experience in one or multiple packaging disciplines including materials and closure systems, design of secondary and tertiary components, component compatibility, component qualification, equipment installation and qualification
- Experience supporting packaging for pharmaceutical products from research, through registration, clinical trials, and commercial launch
- Advanced knowledge of cGMPs and associated CMC regulatory considerations in a pharmaceutical/biotech environment
- Experience working with internal and external contract manufacturers
- Strong understanding and application of validation processes (IQ/OQ/PQ/PV)
- 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 flexibility to accommodate changes in responsibilities or project priorities
- Ability to navigate a fast-paced, highly-matrixed work environment
- Ability to travel domestic and international (approximately 20%)
Education and Experience:
- Bachelor's Degree in Packaging, Chemical, Mechanical, Material Engineering, or a relevant discipline
- Typically requires 6+ years of experience, or the equivalent combination of advanced education and experience.
- Prior experience with cell & gene therapies, biologics, medical devices/combination products or aseptic fill/finish preferred.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
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
