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Senior Manager, Packaging Engineering

4 months ago

Boston, United States Vertex Pharmaceuticals Full time

Senior Manager, Packaging Engineering page is loaded

Senior Manager, Packaging Engineering

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locations

Boston, MA

time type

Full time

posted on

Posted 10 Days Ago

job requisition id

REQ-21123

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 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. 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

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. 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.

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