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Scientist - Oral Drug Product Development (M/F)
5 meses atrás
Join a Market Leader:
Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.
Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.
Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.
You will be responsible to:
Responsibility over the development, scale-up, registration/validation of drug substance, particle engineering and drug development programs in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Oversees the manufacturing process for clinical or commercial supplies of materials in cooperation with areas and supports safety/hazard analysis and other technical support areas as required. Promotes the scientific excellence and innovation in the area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Resolve a wide range of technical aspects within multiple projects in order to reach the established targets
- Execute the projects according to the agreed work plan, selecting methods and techniques for obtaining the best solutions
- Give Technical Support to projects of the group not directly under own responsibility
- Present recommendations and builds on other’s ideas
- Generate technical documentation
- Contribute to the improvement of processes and procedures
- Communicate with clients on and other parties on project related topics
- Recommend methods and procedures on new or special assignments
- Develop new procedures and methodologies based upon experience and innovative approach
- Generate Intellectual Property and promote scientific activities & innovation
- Develop own and others’ competences
- Represent Hovione in external events, conferences, etc.
- Participate in inspections and internal and external audits
- Network with peers internal and external outside own area of expertise
- Participate and lead peer reviews in own cross-functional teams and asset groups
- Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner
- Propose improvements to the area as appropriate and solve problems
- Make quality and timely decisions within the Scientist’s tasks under her / his responsibility
- Gather relevant data to inform the decision makers regarding complex issues
- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice
- Responsibility over inhaler device portfolio development: from conceptual design to manufacturing
- Create and evaluate device designs during the complete product life cycle, from conceptual level and IP generation, to detailed design and through manufacturing
- Drive the device product development based on solid engineering principles, knowledge of materials, manufacturing processes, finishing and assembly to develop functional, performant, cost-effective and robust device designs and finding trade-offs in the complex design space of a drug-device combination product
- Lead device verification testing through the product life cycle, identifying methods to test the designs, analyse the results and implement design changes based on these
- Technical lead for new technology implementation in device filling & assembly
- Prepare high-quality technical reports and documentation for supporting the Design History File
- University, or equivalent, qualification in Chemistry, Chemical Engineering, Materials Sciences, Pharmaceutical Technology, Biological Engineering or Biology or Mechanical Engineering (specific for devices) or similar scientific field (mandatory), preferably with a PhD
- Typically requires 3-5 years of relevant experience in Research & Development and/or Operations in the Pharmaceutical Industry or a Ph.D. degree in a relevant scientific field
- Strong understanding and knowledge of Chemical Engineering, Chemistry, Organic Chemistry and Unit Operations, or of Reaction Engineering, Heat Transfer, Scale-up, Process Safety and Industrial Operations, or of
