FSP- Scientist, Process Engineering

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Standard (Mon-Fri)

• Environmental Conditions

Office

• Job Description

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner. At PPD, part of Thermo Fisher Scientific, we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk; our award-winning training programs speak for themselves.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to demonstrate the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical / biopharmaceutical company, all while maintaining full-time benefits.

Our client is seeking a highly motivated process engineer to support the  Drug Substance Development (DSD) team.  As a member of Drug Substance Development, you will use your engineering, chemistry and analytical knowledge and expertise to scale up the drug substance process for primary manufacture and contribute to the development and deployment of innovative processes and technologies to enable delivery of our medicines.

• Key Responsibilities :
• Work safely, effectively and collaboratively on multi-disciplinary development teams, alongside Chemists, Engineers, Material Scientists, Analysts, and Modelers to deliver work packages required to understand API unit operations for effective scale-up.
• Safely implement laboratory protocols and experiments for key chemical unit operations using online trending of relevant process parameters to contribute high quality chemical engineering knowledge to project teams, advising R&D decision making
• Characterize chemical processing equipment across multiple scales, delivering key engineering knowledge for the successful scale-up of API manufacturing processes.
• Develop process models for unit operations which demonstrate predictive capability and first-principles process understanding.
• Learn and undertake setting up, operating and maintaining PAT equipment to collect process data for developing PAT methods (e.g. Mid IR, Raman, NIR, MS, HPLC, Particle Size, pH, conductivity, etc.)
• Interpret experimental results and related information to generate clear process analytical knowledge that can be used to identify potential issues, facilitate optimization and control, and help provide solutions.
• Perform data management and some data interpretation, recording results effectively and communicating results in technical reports.
• Optimally present at internal meetings.  May participate in technical reviews on projects.
• Follow local regulatory and data integrity requirements, including cGMP and cl policies and procedures, with high quality and attention to personal safety.
• Education and experience :

BS in Chemical Engineering or related degree (i.e. mechanical engineering, bioengineering, biomedical engineering) and a minimum of 2 years of related experience

• In some cases an equivalency, consisting of appropriate education, training, and / or directly related experience will be considered sufficient for an individual to meet the requirements of the role.’
• Knowledge, skills and abilities :
• Experience in reaction engineering, separation technologies, fluid dynamics, scale-up of pharmaceutical unit operations, and / or systems modeling
• Experience in making contributions to multi-disciplinary pharmaceutical product development teams, with a track record of collaboration
• Broad knowledge of process development in support of manufacturing development
• A working knowledge of Quality by Design (QbD) principles and / or a risk-based approach to pharmaceutical development
• Effective oral and written communication skills
• Proven track record to solve and diagnose problems
• Solid understanding of organic chemistry

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!