Principle Scientist Combination Product
|Contact Name:||Gerry Kennedy Director of The RFT Group|
Combination Product Development Dublin pharma
Ambitious expansion plans of the Dublin based Drug Development team have led to the establishment if this exciting position. This opportunity offers a rare chance to make a key contribution towards building a successful ambitious young company.
Reporting to the Director, Combination Product Development & Integration, the position of Principal Scientist/Engineer Combination Product Development will provide technical leadership in the design, development, manufacture, and testing of drug-device combination products such as injectables and nasal sprays.
The Principal Scientist/Engineer Combination Product Development will be responsible for the development, compilation and maintenance of the design history file, risk management file and human factors engineering 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 Principal Scientist/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.
• Technical lead on a project to integrate drug product and device constituent part development into combination
product development and commercialization of new products and life-cycle management activities of commercial
• 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
• Oversight and management of design history file compilation and maintenance
• Oversight and management of combination product risk management
• Oversight and management of human factors engineering activities
• In collaboration with drug product and device development SMEs, establish the combination product manufacturing
strategy, equipment, and process flow
• Lead activities in manufacturing process development of the combination product
• 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, stability specifications for combination products
• Technical oversight of team responsible for design transfer of combination product
• Provide peer review and technical inputs on the key regulatory submission documents, e.g., NDA, FDA Type C, EMA
• Responsible for leading a technical team during regulatory and notified body inspections by representing the team in
front of auditors and ensuring audit readiness
• 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
• Degree (preference advanced degree) in Pharmacy, Pharmaceutical Sciences, Mechanical Engineering
(or similar disciplines). Master’s degree or PhD preferred.
• Depth of experience is essential in drug-device combination product research and development.
• 5+ years direct experience in pharmaceutical development and/or medical device development
including manufacturing process development and scale up from lab scale to pilot scale to
• Direct experience of QBD (quality by design) principles and application of ICH principles to
• 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.
• Direct experience with generating documentation for CMC for regulatory filings for pharmaceutical
products is desired.
• Direct experience in the application ISO 14971 Risk Management for Medical Devices to product
development is essential.
• Experience in design, development and qualification of a broad range of pharmaceutical drug-device
combination products such as: pre-filled syringes, autoinjectors, long acting injectables, nasal sprays
and implantable dosage forms.
• Experience in the development of sterile products.
• Experience of injection molding process development and tool design is desired.
• Experience in developing automated manufacturing equipment is desired.
• General experience of clinical trials.
• 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. Direct experience in human factors engineering is desired.
• Thorough 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 essential.
• 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.