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Package Engineering Senior Manager

Semma Therapeutics

Semma Therapeutics

Marketing & Communications, Product
Boston, MA, USA
Posted on Thursday, February 8, 2024

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.

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, 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 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
  • 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 30%)
  • 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.
  • 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