- Provides guidance and feedback to drug development teams and regulatory functions in responding to health authorities worldwide
- Transfers methods to development and commercial labs around the world
- Collaborates with formulation and manufacturing colleagues in order to optimize processes and improve productivity.
- Conducts testing as per assigned technique and methods.
- Documents work in laboratory notebooks and other systems and as per GMPs and department SOPs.
- Acquires, reviews and/or approves in GMP compliant manner, data related to methods development and testing of GMP and development materials. Prepares reports for methods, validation, and technology transfer.
- Sustains up to date knowledge on applicable department and site standard practices related to GMPs, safety and controlled substances as appropriate to work.
- Provides input, and may author standard practices.
- Assists in purchase and implementation of new technology
- Participates in laboratory investigations/inspections.
- Conducts Microbiology Investigations and implement CAPAs as needed
- Serves as a member of interdisciplinary development teams, providing scientific and operational input to development plans
- Drafts responses and corrective actions to internal compliance questions related to their work.
- Writes and revises SOPs, WIs and Methods as needed.
- Writes and implement change controls.
The qualified individual will have the following background
- Bachelor Degree in Microbiology or related scientific discipline with 3 to 7 years experience in pharmaceutical microbiology.
- Good communication skills, both written and verbal, are required.
- Experience with bacterial endotoxin test, bioburden and sterility, with in-depth understanding of the method, and possible interferences
- Experience with instrument qualifications in a microbiology environment is a plus.
- Knowledge of basic compendial microbial test methods is also a plus.
- Demonstrated ability to solve non-routine analytical issues and provide guidance to laboratory and external colleagues.