The Role/Job Duties:
- Plan, prioritize, organize and execute the conduct of the Sample Management Office and Stability Chambers work within the Site Operations Support Department in accordance with the requirements of the client contract and/or technical agreement.
- Oversee projects and maintain project timelines and budget, serve as Project Technical Lead with internal and external customers and serve as Subject Matter Expert for stability and stability environmental conditions (chambers) and Sample Management activities.
- Ensure that safe working practices are adopted in the areas and to comply with in-house SOPs and other safety legislation - Perform checking & verifying of documentation in accordance with in-house SOPs.
- Assist in production of costing and timelines for client projects - Report revenue forecasts on a regular basis.
- Maintain awareness of modern techniques and their application to Pharmaceutical Sciences activities.
- Ensure that appraisals and performance reviews are carried out in accordance with company policy. Identify training needs of subordinates through discussion and with reference to the core competencies.
- Assure the integrity and quality of analytical data produced by ensuring staff are adhering to all relevant in-house and client SOPs and methodologies and following the requirements of GMP.
Education or Equivalent:
- Bachelors Degree in a scientific field preferred.
- 5 years relevant industry experience with 3 years of people leading experience preferred.
- Experienced in most aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones.
- Has substantial breadth/depth of technical acumen in multiple techniques with significant expertise in one or more techniques and can understand their application in context of pharmaceutical services offerings.
- Leadership development skills are expected - Excellent motivator, well versed in team development.
- Understand the details of regulatory CMC filing package and analytical and formulation documentation required. Has the ability to write and review documents for regulatory filings.