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Associate Director – Packaging Engineering New Product Commercialization

Hampton Research

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Boston, MA
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Job Description

As posted by the hiring company

Job Overview:

Job Description

Vertex Pharmaceuticals is currently looking for an Associate Director, Packaging Engineering to be located in our Boston, MA headquarters. With this exciting growth, you will manage and design key packaging activities including packaging design and specification, equipment and tooling design and qualification, labeling, material selection, testing, and sourcing. This position will ensure optimal supplier performance and continuity of supply by maintaining strong partnerships with external suppliers of packaging operations, materials, and services for Vertex development and commercial products. The Associate Director, Packaging Engineering will work effectively with multiple stakeholders including Pharmaceutical Development, CPO’s, Regulatory Affairs, Project Management, Supply Chain, Quality, and Marketing to meet project timelines and objectives. The candidate will evaluate alternate materials, closures, labels, and processes to identify optimal packaging solutions for development products, and to support continuous improvement activities for commercial products.

This position is for an Associate Director, Packaging Engineering to be focused on new package development. Packaging is responsible for package design, testing, and specification development of packaging systems included in filings through World-Wide commercial product filings and supporting product stabilization after commercial launch.

KEY RESPONSIBILITIES:

  • This role will collaborate with R&D, Marketing, Supply Chain, Logistics, Manufacturing sites, External Manufacturing, to develop, transfer and launch packaged products for US and export markets
  • Work with technical project teams as packaging expert to guide new products through late-stage development, registration, validation, and launch
  • Provides commercial technical support and leadership at packaging sites including change management, technical investigations, robustness etc.
  • Directed end-to-end packaging validation activities and be responsible for authoring and reviewing packaging qualification and validation documents.
  • In-depth knowledge of primary and secondary packaging materials and systems for pharmaceutical drug products (tablets/capsules/vials/syringe) with knowledge of global regulatory requirements related to design and control of these processes
  • Knowledge of cGMPs and associated regulatory considerations in a commercial pharmaceutical packaging environment
  • Strong understanding and application of validation processes (IQ/OQ/PQ/PV)
  • Experience supporting packaging for pharmaceutical products from research through registration and launch
  • Strong communication, collaboration and team building skills; ability to connect with all levels of the organization
  • Liaises with Regulatory Affairs and Quality to provide packaging documentation supporting process validation, product release and regulatory filings
  • Work with technical project teams as packaging expert to guide new products through late-stage development, registration, validation, and launch
  • Assist in setting overall strategy for packaging and labeling areas
  • Effectively influence key stakeholders to advance department and corporate objectives

Required Knowledge/Skills

  • Advanced knowledge of cGMPs and associated CMC regulatory considerations in a pharmaceutical environment
  • Experience/Interest in multiple solid dose packaging disciplines: materials, bottle and closure systems, blister packaging, design of secondary and tertiary components, component compatibility, component qualification, equipment installation and qualification
  • Demonstrated ability to manage multiple high-priority projects concurrently
  • Proven ability to communicate clearly and concisely (written/oral)
  • Ability to navigate and be successful in a fast-paced, highly matrixed work environment

Other Requirements

  • Ability to travel domestic and international. (Approximately 20%)

Education and Experience:

  • Bachelor's degree in relevant field
  • Typically requires 8 years of experience of work experience and 2 years of supervisory/management experience, or the equivalent combination of education and experience

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.

Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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.