When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
Division Specific Information
We operate the world’s largest Pharma Services business, offering drug substance, drug development, clinical trials and drug product solutions to companies of all sizes. We help customers get high-quality medicines to patients faster. We are experts at simplifying the supply chain, can help solve complex manufacturing challenges and shorten development timelines.
How will you make an impact?
Provides dedicated customer support from a technical perspective on a day-to-day basis in the Formulation, Filling, and/or Freeze-Drying areas of the Steriles plant. Investigates, creates, and validates scientific methodologies used to control raw materials, production intermediates, and final products on a complex scope of processes, products, and projects. May be involved in pre-clinical, clinical, and/or post-marketing stages of drug development.
Works on technical/scientific process/product/project activities to execute strategies and technical solutions that meet client needs and expectations. Participates in technical discussions with clients with a high level of technical proficiency. Engages in creation of processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients. Evaluates and contributes to the design of manufacturing processes and supports problem solving as necessary with independent judgment. Makes decisions that require developing new options to solve complex problems.
What will you do?
- Interacts and provides dedicated customer support based on the client's portfolio. Leads strategic initiatives and solutions. Works closely with site management to optimize requirements of both client and site for portfolio of projects.
- Executes and writes deviation investigations to identify the root causes of departures from standards and to assess product impact.
- Implements corrective actions and preventive actions (CAPAs) to eliminate the root causes of deviations.
- Monitors processes to proactively mitigate the risks of deviations.
- Troubleshoots issues when deviations and/or process upset situations occur.
- Implements continuous improvement projects to drive improved process efficiency and efficacy.
- Writes and manages department Standard Operating Procedures (SOPs), Batch Production Records (BPRs), Training documents, Protocols, etc. to ensure operational excellence and regulatory compliance.
- Participates in development of scientific strategy.
- Develops realistic proposals and timelines. Leads meetings/teleconferences with clients.
- Coordinates development of methods and processes that meet or exceed the expectations of clients and provides innovation as necessary.
- Coordinates research of industry practices and processes and applies research to innovative drug development internally and for client products. Presents recommendations internally and to clients.
- Leads projects without supervision; may lead multiple projects, including managing project timelines and deliverables.
- Guides and advises during implementation of new methodologies and processes.
- Liaises with internal scientific, analytical, and laboratory functional areas to meet project and team objectives.
- Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines. Maintains the necessary compliance status required by company and facility standards.