Package Engineering Senior Manager

Job Description JOB TITLE: Package Engineering Senior Manager LOCATION: 50 Northern Ave., Boston, Massachusetts, 02210 OPENINGS: 1 DUTIES: Represent department on cross-functional CMC sub-teams, with minimal guidance. Ensure positive and effective relationships with key suppliers of materials, technology, and manufacturing resources. Manage and design key packaging activities including packaging design and specification, equipment and tooling design and qualification, labeling, material selection, testing, and sourcing. Work effectively with multiple stakeholders including Pharmaceutical Sciences, Manufacturing Sciences & Technology, Regulatory Affairs, Project Management, Supply Chain, Quality, Marketing and other cross functional departments to meet project timelines and objectives. Review process performance to identify continuous improvement activities for commercial products. Lead technical transfer and process validation activities; responsible for authoring and reviewing packaging qualification and validation documents. Translate product specifications into Packaging Design Documentation, ensuring enough detail is captured for Process Development and Manufacturing purposes. Work with domestic and international CMO (Contract Manufacturing Organization) to implement packaging solutions for product launch. Prepare definitive specifications or revisions with appropriate testing. Develop packaging systems that align with User Requirements, Functional Requirements, and Regulatory requirements. Manage Change Control, work with Cross-Functional Team for Impact Assessment, and manage timely completion of activities while ensuring updates are made to relevant documents. Support technical aspects of New Product Commercialization by effectively utilizing knowledge and first-generation learnings to design and develop commercial product packaging. With cross-functional input, author and execute study protocols and applicable testing regimens, and document all Root Cause Analysis Reports. Perform technical risk assessment related to packaging design and processes for new and commercial released products. Position requires 20% domestic and international travel. Telecommuting permitted up to 40%. REQUIREMENTS: Employer will accept a Bachelor's degree in Packaging, Mechanical, Chemical, or Material Engineering, or a related field and 96 years of experience in the job offered or in a Package Engineering Senior Manager-related occupation. Position requires demonstrable experience in the following: In depth 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 for Cell & Gene therapies, Biologics, Aseptic fill/finish or Medical Devices/Combination type products. In depth experience supporting packaging of medical device or pharmaceutical products from research, through registration, clinical trials, and commercial launch. Experience with Container Closure Integrity (CCI) per USP<1207>, <1207.1>, <1207.2>, and <1207.3> In depth experience with packaging design verification (sterilization, environmental conditioning, shelf-life testing, distribution simulation and packaging performance testing) and validation studies including formative or summative studies. In depth experience with CAD 3D modeling (SolidWorks), drawings, 3D printing and product performance testing. Advanced knowledge of cGMPs and associated regulatory consideration in a medical device or pharmaceutical environment. Experience working with internal and external contract manufacturers. Strong understanding and application of validation processes (IQ, OQ, PQ, and PV). Comprehensive knowledge of Design Control and risk management including experience with Risk Analyses using d.F.M.E.A., u.F.M.E.A and p.F.M.E.A tools. Thorough understanding of c.G.x.P principles and practices, ISO 13485, ISO 14971, and 21 C.F.R. 820. Strong understanding of statistical principles, including hypothesis testing and process capability analysis. Experience with U.S. F.D.A. and E.U. Risk Analysis methods. Familiarity with Root Cause Analysis relating to Process, Product or Packaging Development. Position requires up to 20% domestic and international travel. Telecommuting permitted up to 40%. Rate of Pay: $138,400.00- $207,600.00 CONTACT: Send Resume to futuretalent@vrtx.com. Reference 12140.422. EOE. #LI-DNI Pay Range: $138,400 - $207,600 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: 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. #LI-Hybrid 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 Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.