What are the responsibilities and job description for the Scientist/ Senior Scientist - Particle Engineering position at Hovione?
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.
The Scientist role is responsible for execution of projects at Hovione Technology Transfer (TTC) to achieve clients’ expectations and Hovione objectives and in compliance with all Federal, State and Local requirements, namely: EPA, OSHA and FDA, and with all Hovione internal policies. This role will aaccomplish project timelines, product quality, required quantities and project budget to guarantee that all steps are carried out according to cGMP rules.
You will be responsible to:
- Lead and coordinate multiple projects making use of state-of-the-art tools and methodologies to ensure the achievement of the established objectives.
- Plan and monitor execution of development campaigns and executes scale-up runs in the R&D laboratory.
- Developing drug product manufacturing processes for oral products, including scale up, technology transfer and design space definition.
- Prepare process related documentation (e.g. batch production records, bill of materials) and campaign reports.
- Support the development of new tools and methodologies for process and pharmaceutical formulation development and scale-up.
- Provide scientific and technical support for key stakeholders within the company.
- Comply with the Good Manufacturing Practices (GMP) and HSEE directives.
- Contributes to the Process Hazard Analysis (PHA) of all processes under his/her responsibility.
- Assists in the preparation of Technology transfer packages and technology transfers of processes/products either to Hovione or clients facilities.
- Keep updated of relevant occurrences and trends that affect the business.
We are looking to recruit a candidate with:
- PhD degree in the field of Engineering, Science or Pharmacy, preferable in Chemical Engineering, Mechanical Engineering, Materials Science or Pharmaceutical Technology.
- Robust Knowledge in one of the following technical areas: Spray Drying and/or Amorphous Solid Dispersion, Oral Drug Product, Continuous Tableting.
- Advanced Knowledge in at least one of the following areas: Formulation Development, Pharmaceutical processes scale-up, drug delivery.
- Demonstrated expertise in drug / process development. Preference will be given to candidates with expertise in statistical analysis and/or process modelling / simulation;
- Able to understand the impact of decisions and actions in other areas.
- Able to communicate and motivate the team to accomplish success in the execution of projects.
- Able to make coherent decisions in the processes based on defined priorities and the best judgment of the technical data available.
- Maintain knowledge and understand cGMPs as per ICH Q7 and CFR21 parts 210 to 211.
- Result driven, team player and able to deal with multiple projects/tasks;
- Creative and analytically minded with good problem solving skills;
- Good capacity for planning, execution and coordination;
- High sense of responsibility;
- Capable of taking short notice decisions with incomplete datasets and operating under pressure;
- Passion for science and innovation;
- Fluent in English and with excellent written and verbal communication skills.
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.