Job Description

General/Position 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 small molecule products.

Key Duties & 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, 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.

Required Education Level

• Bachelor's Degree in Packaging, Chemical, Mechanical, Material Engineering, or a relevant discipline

Required Experience

• Requires 6 years of experience, or the equivalent combination of advanced education and experience.
• Prior experience commercializing small molecule products is a plus.

Required Knowledge/Skills

• Experience in one or multiple packaging disciplines including materials and closure systems, design of secondary tertiary components, component compatibility, component qualification, equipment installation and qualification
• Experience supporting packaging for pharmaceutical products from research through registration and launch
• Advanced knowledge of cGMP’s and associated CMC regulatory considerations in a pharmaceutical environment
• Experience working with 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

Other Requirements

• Ability to travel domestic and international (approximately 30%)

Pay Range:

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

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