We are looking for Head R&D Microbiology having exposure to US markets with an experience in liquid injectable products & successfully managing a team of 10-20 scientists.
- Candidate will lead R&D microbiology team responsible for the following activities:
- Development, validation, and transfer of microbiological methods as required
- Qualification of alternate suppliers of active pharmaceutical ingredients
- Expansion of approved products into new global markets
- Review, alignment and implementation of compendial changes for on-market products
- Provides technical direction, development, and training for new and current employees with respect to documentation, use of equipment, laboratory techniques, and department procedures within their assigned area of responsibility. Plan, perform, monitor, interpret and document DS/DP related microbiological activities including method development/validation, stability testing, etc.
- Responsible for the scientific quality of all project activities and associated timelines for microbiological R&D projects within the organization.
- Ensure that the department is cGMP compliant.
- Responsible for mediating and resolving issues/conflicts from within the department and outside department in regard to Microbiological aspects of R&D projects, lab operations, and general laboratory compliance.
- Ability to prioritize and decide appropriate course of actions. Effective at implementing decisions.
- Interact/collaborate within different organisation's locations and other CMO’s identified to facilitate transfer of microbiological methods for DS/DP.
- Assess opportunities for rapid microbiological technologies and implement as appropriate.
- Advise team members and work according to appropriate SOP’s, GLP and GMP.
- Training and evaluation (SOP and on the job Training) of lab personnel on time.
- Investigation of ERs/LIRs/OOS and ability to take remedial action.
- Knowledge of Microbiological Method development /Method validation/Stability analysis.
- Knowledge of kinetic methods of Bacterial Endotoxin Testing
- Strong knowledge of cGMP, GLP and GDP procedures etc.
- Fully versed in ISO, ICH Guidelines, FDA, and other regulatory agency requirements for validation and execution of microbiological methods and transfer of methods to manufacturing plants.
- Thorough understanding of development activities and processes in pharmaceutical industry.
- Ability to work in and/or lead interdisciplinary and/or cross-cultural teams.
- Excellent communication, presentation skills and scientific/technical writing skills
We know the industry just as well as you, and are we committed to providing you with the best placement experience possible.