When you are part of the team at Thermo Fisher Scientific, you will do important work, and you will be valued and recognized for your performance. With talented managers and inspiring coworkers to support you, you will find the resources and opportunities to make significant contributions to the world.
To provide laboratory testing support to meet the business objectives of Thermo Fisher Scientific.
- Manages staff responsible for the day-to-day operations of multiple quality operations. Review departures from procedures and recommend action for approval by Sr. Group Leader/Manager/Director. Approve GMP records.
- Monitor the performance of staff such that corporate and business goals are met. Meet throughput goals for batch dispositions, assessment, investigations, and validation projects. Recruit and develop staff. Train staff. Apply progressive discipline programs as required.
- Develop and implement policies and procedures. Implement approved changes in collaboration with labs, production, regulatory, client and Quality. Ensure that work is appropriately documented per GMP. Make decisions regarding acceptability of results and documentation. Identify issues requiring review by management.
- Establish actions and implement systems to achieve process improvements and efficiencies to address shortcomings in processes and systems. Serve as principle in problem solving, failure analysis and quality or process system design activities related to product quality. Evaluate protocols, procedures, documents and results for scientific and/or business merit. Ensure areas of responsibility are compliant with industry standards and trends.
- Draft submission ready sections of regulatory dossiers for drug products for approval by management. Draft specification rationales for drug products. Draft standard operating procedures. Write appropriate reports and correspondence. As needed, write reports for clients.
- Maintain knowledge of public standards, regulatory trends and cGMPs. Serve as the technical and regulatory expert in their operational area. Back up to key regulatory inspection contact. Participate in negotiations with clients, regulatory reviewers and inspectors on issues to assure timely resolution of issues or approval of client applications.
- It is the responsibility of each employee to work in a safe and responsible manner in order to create an injury-free and incident-free workplace.
- BS/BA degree in a scientific or related discipline with four (4) years relevant experience to include two years leadership experience; OR AA/AS degree in a scientific or related discipline with five (5) years relevant experience, including two years leadership
- Chemistry and dissolution experience.
- Knowledge of methods development approaches, analytical validations, quality control statistics, documentation and adherence to SOP’s.
- Ability to write quality technical reports and give effective oral presentations.
- Ability to effectively collaborate with others to achieve team goals and expectations.
- A genuine interest in researching and implementation of new approaches to analysis.
- Experience in the pharmaceutical industry preferred.
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.