Combination Product Development Engineer

Contract Type: Permanent
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Job Description

Engineer, Combination Product Development
Reporting to the Director, Combination Product Development & Integration, the newly created position of Engineer, Combination Product Development will provide technical support in the design, development, manufacture, and testing of drug-device combination products such as injectables and nasal sprays.

The Engineer, Combination Product Development, will be responsible for the development, compilation, and maintenance of the design history file and risk management file of drug-device combination products from identification of user needs, conceptualization, design, and development, transfer to manufacturing, product launch and life-cycle management.

In collaboration with Drug Development and Device Development technical leads and other relevant stakeholders, the Engineer, Combination Product Development will be responsible for the technical interface between the constituent parts of the combination product during development ensuring products are developed and manufactured according to regulatory and GMP, ICH, ISO, and other applicable requirements.

Essential Functions
  • Provide technical expertise and support to the project team for integration of drug product and device constituent part development into combination product development, commercialization of new products, and life-cycle management activities of commercial products.
  • Technical interface between drug product and device development teams to support CMC development plans related to drug-device combination product development with emphasis on container closure development, biocompatibility, microbiological attributes, stability, and sterilization process development
  • Compilation and maintenance of design history file
  • Compilation and maintenance of combination product risk management
  • Support human factors engineering activities
  • Support or lead activities in the manufacturing process development of the combination product
  • Support or lead combination product manufacturing campaigns and responsible for providing technical inputs, batch record review/approval, and on-site presence for development, clinical/registration campaigns
  • Established critical process parameters and establish control strategy to support combination product manufacture for product registration and commercial manufacture
  • Develop and generate in-process, intermediate, release, and stability specifications for combination products
  • Provide peer review and technical inputs on the key regulatory submission documents, e.g., NDA, FDA Type C, EMA scientific advisory
  • Provide support to the technical team during regulatory and notified body inspections
  • Write study protocols, technical reports, and SOPs
  • Analyze and present data to cross-functional project teams, leadership, and CMO
  • Conduct all work in compliance with Standard Operating Procedures and regulatory requirements.
  • Contribute to the establishment of combination product development procedures and practices within the R&D unit
Person Spec
  • A minimum of a Bachelor's or advanced degree in the field of Pharmacy, Pharmaceutical Sciences, Mechanical Engineering (or similar disciplines). Master’s degree or PhD preferred.
  • 3+ years of experience in drug-device combination product research and development is essential. 5+ years is preferred.
  • 3+ years direct experience in pharmaceutical development and/or medical device development
  • Direct experience of generating and managing design control documentation as per the requirements of FDA 21 CFR part 820 and ISO 13485 Design Control is essential.
  • Knowledge of quality by design principles and application of ICH principles to pharmaceutical development.
  • Knowledge of documentation for CMC for regulatory filings for pharmaceutical products is desired.
  • Knowledge of the application ISO 14971 Risk Management for Medical Devices to product development.
  • Experience in design, development, and qualification of pharmaceutical drug-device combination products such as: pre-filled syringes, autoinjectors, long-acting injectables, nasal sprays, and implantable dosage forms.
  • Knowledge of sterile product development is desired.
  • Experience of injection molding process development and tool design is desired.
  • Experience in developing automated manufacturing equipment is desired.
  • Proficiency with 3D computer-aided design (SolidWorks) is desired
  • Experience with Design of Experiments (DOE) and statistical analysis is desired
  • Knowledge of human factors engineering principles for medical device and combination product development is desired.
  • Knowledge of industry standards, FDA guidance, quality systems, verification, validation, design transfer, and quality engineering principles for medical devices and combination products
  • Demonstrated ability to create and execute to technical plans and timelines (MS Project preferred)
  • Track record of successfully managing third-party sub-contractors is desired.
  • Strong communication skills and ability to drive cross-functional decision making
  • A true self-starter, who works effectively on their own initiative, and is used to working in demanding environments, where there is continuous change and ambiguity.
  • Highly organized, with exceptional time management and prioritization
  • Critical thinking evaluation of process problems
  • Strong work ethic
  • Flexibility to travel on company business when required.
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