Job Title: Analytical Development Manager
As a key member of the Process Development Services Team, you will collaborate with clients to introduce new products.
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 project teams to ensure they achieve their results
* Lead analytical discussions with customers and communicate with SMEs in Process Development, Project Management, QA, QC and IPC groups
* Ensure 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 analytical chemists in their professional development ensuring 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
Minimum Requirements/Qualifications:
* Degree, Masters or PhD 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 and participate in PPI (Practical Process Improvement) initiatives to identify improvements and cost saving to the business