Analytical Development Senior
Description✓Pharmaceutical Manufacturer and Developer requires an experienced Analytical Development Senior.
✓About the role:
✓Reporting directly to the R&D manager the Analytical Team Leader will coordinate and oversee all analytical method development & validation activities within the R&D team
✓The role also involves hands-on development & validation experimental work to ensure that all project timelines are met from product feasibility through to analytical validation
✓Coordination of additional testing requirements for process validation batches also forms part of this role.
✓Duties may include:
✓Coordination & oversight of all the workload of the Analytical Development Team.
✓Line management responsibility for the Analytical Development Team including goal setting, tracking of performance and year end performance reviews for direct reports.
✓Development of analytical methods appropriate for raw materials, in-process controls and intermediate/final API's.
✓Validation of analytical methods in accordance with current regulatory expectations suitable for ASMF submission.
✓Coordination of all annual qualification programs for analytical equipment in R&D to ensure they are conducted to schedule.
✓Close team-working with research and quality functions to ensure analytical methods are developed and implemented in time to meet project/customer deadlines.
✓Developing presentation materials and giving presentations on technical topics.Skills and Experience:
✓Degree in Analytical Chemistry or equivalent.
✓Strong knowledge of HPLC, GC, IR, UV and [HP]TLC techniques.
✓Experience of method development and validation as per ICH requirements.
✓Technology transfer of newly developed methods to QC team both internally and externally
✓Setting specifications for raw materials, in-process checks and finished product.
✓Knowledge of general analytical methods used for herbal raw materials and API's would be advantageous.
✓Knowledge of particle size analysis, dry powder method development and wet chemical techniques would be advantageous.
✓Analytical Team Leader experienceApply now for more information Show more →
✓About the role:
✓Reporting directly to the R&D manager the Analytical Team Leader will coordinate and oversee all analytical method development & validation activities within the R&D team
✓The role also involves hands-on development & validation experimental work to ensure that all project timelines are met from product feasibility through to analytical validation
✓Coordination of additional testing requirements for process validation batches also forms part of this role.
✓Duties may include:
✓Coordination & oversight of all the workload of the Analytical Development Team.
✓Line management responsibility for the Analytical Development Team including goal setting, tracking of performance and year end performance reviews for direct reports.
✓Development of analytical methods appropriate for raw materials, in-process controls and intermediate/final API's.
✓Validation of analytical methods in accordance with current regulatory expectations suitable for ASMF submission.
✓Coordination of all annual qualification programs for analytical equipment in R&D to ensure they are conducted to schedule.
✓Close team-working with research and quality functions to ensure analytical methods are developed and implemented in time to meet project/customer deadlines.
✓Developing presentation materials and giving presentations on technical topics.Skills and Experience:
✓Degree in Analytical Chemistry or equivalent.
✓Strong knowledge of HPLC, GC, IR, UV and [HP]TLC techniques.
✓Experience of method development and validation as per ICH requirements.
✓Technology transfer of newly developed methods to QC team both internally and externally
✓Setting specifications for raw materials, in-process checks and finished product.
✓Knowledge of general analytical methods used for herbal raw materials and API's would be advantageous.
✓Knowledge of particle size analysis, dry powder method development and wet chemical techniques would be advantageous.
✓Analytical Team Leader experienceApply now for more information Show more →