Job Title: Analytical Development Manager
The Analytical Development Manager will play a key role in the Process Development Services Team at Thermo Fisher Scientific.
Responsibilities:
* Provide technical support to the analytical development team.
* Support troubleshooting and problem-solving activities and coach the team members to increase their capability.
* Provide mentorship to the project teams to ensure that they achieve their results.
* Lead analytical discussions with customers and communicate with SMEs in the Process Development, Project Management, QA, QC and IPC groups.
* Ensure that safety standards and housekeeping standards are met and encourage a safety mindset.
* Support compliance activities to ensure the team is 'inspection ready' at all times.
* Lead analytical technology transfer activities for the site and transfer analytical methods to the QC and IPC labs.
* Instill a continuous improvement mentality in the team and look to improve and simplify ways of working.
* Evaluate new analytical technologies.
* Work closely with the chemistry development team to provide support to projects as required.
* Support and guide the analytical chemists in their professional development ensuring that they have the required technical training and opportunities for personal growth.
* Author or contribute to regulatory submissions, patents and other internal documentation relevant to the role.
* Develop/Expand scientific, technical, and drug discovery knowledge by reading the peer reviewed scientific literature, attending scientific conferences and via relevant training.
* Work with due care and attention, perform all quality, regulatory and safety duties in a compliant manner whilst acting always in accordance with the Dignity at Work Policy and Code of Conduct.
Requirements:
* Master's or PhD degree in analytical chemistry.
* Extensive proven experience in an analytical chemistry environment.
* Experienced in analytical method development, troubleshooting, validation and transfer.
* Ideal experience in a CDMO environment.
* Experience in managing a team.
* Proficient knowledge of analytical chemistry, particularly in method development, troubleshooting and analytical transfer.
* Experienced in HPLC, UPLC, GC, LC-MS, GC-MS, ICP.
* Experienced in analytical technology transfer and in change control.
* Proven ability to think critically and innovatively combined with willingness to challenge.
* Demonstrated ability in troubleshooting and solving complex issues.
* A strong understanding of the regulatory and compliance requirements for analytical methods and specifications. Knowledge of ICH, FDA/EMA guidelines and USP, PH. Eur.
* Excellent technical writing skills and verbal communication are required to interact with all levels of our organization and clients.
* Ability to work with cross functional teams and engage with employees and customers at all levels.
* Adept at adopting and participating in PPI (Practical Process Improvement) initiatives to identify improvements and cost saving to the business.