Feb 01, 2020

Director, Packaging Development

  • Professional Diversity Network
  • Cambridge, MA, USA
Full-Time Science

Job Description

Biogen

Job Description

Lead the design and process development of patient-centric, safe, reliable, and innovative packaging for Drug Substance, Drug Product and Finished Goods.Beginning with continuous research of cutting-edge technology to develop packaging systems and solutions aligned to the drug pipeline. Effectively and efficiently bring optimized products to market through rigorous engineering by leveraging external partnerships in collaboration with internal Asset Teams, Human Factors, Digital, Devices, Supply Chain, External Manufacturing, Quality, and Regulatory Affairs.

*Responsibilities:

  1. Provides leadership, direction, and accountability for the performance and results of Packaging Design and Development. Development and application of a broad range of packaging solutions for Drug Substance, Drug Product, and Finished Goods, including Bottles and blister packs, adherence and compliance solutions, and tools for therapy adherence.
  2. Develop Packaging platform strategies for Biogen pipeline drugs. Perform assessments of new technologies, including smart packaging and market trends. Utilize information to inform technology development, platform development, and provide input to Marketing/Commercial/Asset/Modalities strategies as needed.
  3. Lead selection of Packaging and Packaging Materials to be developed and marketed commercially, evaluation and definition of patient needs, Packaging design/customizationand engineering, Packaging clinical testing support, and authoring sections of health authority filings, as and when applicable.
  4. Applies broad industry knowledge and commercial awareness to drive product and technology development. Directs the resolution of highly complex problems looking beyond existing methodologies and own discipline to define and resolve complex problems.Make creative operational or organizational decisions.
  5. Contributes to the development of functional/operational long-term strategy and develops annual business plans to ensure alignment.
  6. Guided by organization functional business plans, impacts the department results by supporting and funding of projects, products, services and/or technologies
  7. Oversight of clinical and commercial packaging assembly process engineering and manufacturability, technology transfer support, scale-up, and commercial manufacturing support.
  8. Coaches and mentors staff.Build and lead a high-performance team.
  9. Creates and sustains an environment of experimentation; works across disciplines/ functions to test and advance innovative product, processes, and methodologies; challenges the status quo in order to encourage innovation.
  10. Build strategic work relationships across organizations.Negotiates with senior leaders across the business.
  11. Consistently, create and leverage external network and influence the industry.
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Qualifications

  1. Deep understanding of Packaging Development and exposure to packaging CMOs
  2. Deep understanding of design and process development of extruded, injection and thermoformed molded and assembled packaging products as well as testing and modeling methodologies
  3. Expert in Design For Six Sigma (DFSS) and DFM Methodologies for development and commercialization
  4. Deep Knowledge of Systems and Processes for an end to end packaging organization
  5. Business savvy, proficient of align/consolidate inputs from various part of the organization
  6. Proficient of who to facilitate the interface between the pharmaceutical company and the packaging vendor base.Demonstrated experience of working with contract design and manufacturing organization to drive design development, process development/validation, and perform investigation and issue resolution
  7. Good communication, collaboration, and team-building skills; ability to connect with all levels of the organization
  8. Adaptive, and strong problem-solving skill
  9. Experience of leading functional team and cross-functional project team

Education: Graduate Degree in Engineering field - Packaging, Mechanical or other related engineering field required - plus 12-15 years' experience.

Additional Information

Lead the design and process development of patient-centric, safe, reliable, and innovative packaging for Drug Substance, Drug Product and Finished Goods.Beginning with continuous research of cutting-edge technology to develop packaging systems and solutions aligned to the drug pipeline. Effectively and efficiently bring optimized products to market through rigorous engineering by leveraging external partnerships in collaboration with internal Asset Teams, Human Factors, Digital, Devices, Supply Chain, External Manufacturing, Quality, and Regulatory Affairs.

States

MA  

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