Packaging Development Engineer IV

2 weeks ago

Lexington, Kentucky, United States Takeda Pharmaceutical Full time
About the Role

At Takeda Pharmaceutical, we are a forward-thinking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Job Description

As a Packaging Development Engineer IV, you will lead innovation, development, testing, and validation of all packaging materials for pharmaceutical, biopharmaceutical, and combination products. You will also develop innovative and creative packaging solutions which meet the needs and requirements of our patients, manufacturing teams, and quality teams.

Key Responsibilities:
  • Execute early packaging development activities in a cross-functional team and require pharmaceutical packaging and combination product development knowledge.
  • Develop primary, secondary, and tertiary packaging while managing due dates and project timelines from clinical to commercialization.
  • Implement biopharmaceutical packaging technologies and support clinical and commercial packaging formats.
  • Develop futuristic innovations in packaging technologies to meet future healthcare requirements, including digital and AI.
  • Play an important role and be an interphase between commercial marketing and R&D.
  • Identify and develop sustainable packaging towards lowering carbon footprint, and recycling, including life cycle analysis.
  • Have a solid understanding of packaging materials and manufacturing processes and experience in global packaging standards for pharmaceutical drug products, parenteral container-closure systems, and combination products.
  • Use a combination of principles of packaging technology, design engineering, innovation, and human interface engineering to ensure right-first-time packaging design qualification.
  • Provide technical expertise for developing packaging/labeling material selection, qualification, and process implementation for new product programs.
  • Author and review of regulatory information packages and filings/submissions.
  • Execute or lead packaging design activities by designing and developing packaging solutions to support project requirements.
  • Execute or lead all aspects of a packaging project delivering early phase evaluation to the device sub-team.
  • Deliver on specific performance indicators, including but not limited to (a) successful concept design solutions, (b) visualization of concepts and prototyping as appropriate, (c) successful human factors studies, (d) supporting regulatory submission, and (e) realistic and manufacturable design concepts.
  • Execution Lead for one or more processes, including but not limited to (i) New Product Packaging Technology, (ii) Combination Product and Device Packaging, (iii) Packaging & Art-Work Specifications process including device instructions for use, (v) Packaging Process Development.
  • Ensure proper level of documentation and covers packaging-related aspects in compliance with regulations and cGMP.
  • Will partner with packaging group(s) in GMSGQ to ensure quality in product packaging and drive elimination of customer complaints relating to device and combination products packaging.
  • Will partner with packaging group(s) in GMSGQ to ensure knowledge transfer related to on-market product packaging.
  • Must build and maintain strong relationships with key internal and external partner organizations, including but not limited to, Component Suppliers, Contract packagers, Product Strategy Leads, Quality Assurance, Procurement, Business Development, Research, and Brand Teams.
Requirements

We are looking for a highly skilled and experienced Packaging Development Engineer IV to join our team. The ideal candidate will have:

  • Bachelor's degree in chemistry, biology, pharmacy, engineering or related field and 5+ years industry experience.
  • Master's degree in chemistry, biology, pharmacy, engineering or related field and 3+ years industry experience.
  • Demonstrated experience in the field of pharmaceutical packaging or combination product development and commercialization.
  • Strong technical and scientific skills with proven experience developing drug product manufacturing processes and/or packaging solutions for biologics in primary containers and devices.
  • Direct experience in packaging partner/contract packaging development and mfg. is preferred.
  • Knowledge and application of cGMP requirements and demonstrated application of industry guidance/standards documents (e.g., ISPE, PDA, ASTM, ISO, ICH, Pharmacopeias) and Regulatory combination product guidance documents applicable to the role.
  • Strong problem-solving skills, excellent communication and cognitive skills, proven capabilities in Computer Aided Designs (CAD) and Product Development rendering skills.
  • Good understanding of manufacturing process and packaging construction methods.
  • Ability to work in a team fulfills commitments, and manage multiple stakeholders.
  • Experience drafting portions of combination product technical content.
  • Proven ability to author user requirement specifications, technical protocols, reports, and assessments.
  • Previous project team experience with technology transfer.
  • Hands-on experience with concept development and feasibility testing.
  • Experience in global product launches and the associated CMC regulatory requirements.
  • Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents, and DEA Regulations is preferred.
  • Knowledge about environmental sustainability and life cycle analysis, including working on LCA software.
  • Demonstrated ability to manage multiple projects of variable complexity simultaneously.
  • Travel up to 25% may be required.

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