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::Suggests, develops and implements process analytical tools to boost the company efficiency in the areas of Drug Substance, Drug Product Intermediate and Drug Product. Oversees and qualifies the implementation of these tools in the manufacturing assets in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Assures modelling practices and methodologies are aligned with the state of the art. Promotes the scientific excellence and innovation in the area of Modelling and PAT and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Provide technical support (analytical and statistical) in multiple projects, ensuring the achievement of the established objectives, aiming for Target Quality, customer satisfaction and faster decision processes with less intensive labor processes
- Ensure a proper usage of complex mechanistic modelling during process development
- Implement PAT tools and practices in complex contexts with multiple factors
- Identify improvement opportunities with operational teams across all Hovione sites, define improvement targets and propose an action plan
- Manage the support of the Technology Transfer and scale-up of projects to Pilot Plant and Manufacturing Areas
- Investigate, promote and implement improvements to batch and continuous manufacturing processes
- Develop mathematical models to monitor and forecast important metrics to the company
- Present solutions to automate routine knowledge work
- Review and write complex reports from RD development campaigns and GMP manufacturing
- Search continuously and implement new tools and methodologies, sharing best practices within the company and promoting innovation and knowledge sharing
- Train less experienced team members in PAT and modelling tools
- Promote the company through presentations at international conferences and to customers, and through patents and publications
- Master Modelling & PAT processes and tools
- Manage complex projects/ analysis with significant impact on business
- Make quality and timely decisions based on multiple sources of data
- Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals
- 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
- University, or equivalent, qualification in Engineering or scientific field (mandatory), preferably with a PhD
- Typically requires 5-8 years of relevant experience in a production environment, preferably within the Pharmaceutical Industry. A Ph.D. degree in a relevant scientific field is typically considered equivalent to 4 years of relevant experience.
- Advanced knowledge of process modelling, simulation principles, PAT and statistical tools (including chemometrics) with the ability to solve complex problems.
- Fluency in English is a requirement
- Computer literate with good working knowledge of the MS Office package and relevant modeling software (Python, Matlab, Simca, JMP)
- Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down
Hovione is a proud Equal Opportunity Employer
Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.