We are seeking a skilled laboratory professional to drive operations within our new facility. This role will involve oversight of equipment qualification, documentation generation, and SME review of SOPs and work instructions.
* Drive laboratory operations within the new facility, overseeing equipment qualification, documentation generation, and SME review of SOPs and work instructions.
* Review and/or lead the trending and reporting of laboratory data to support batch release and maintain oversight of review metrics.
* Maintain and release laboratory stock, ordering laboratory consumables as required.
* Participate in functional meetings, leading departmental and cross-functional meetings as needed.
* Support internal and external audit and inspection activities, ensuring permanent inspection readiness.
* Support site safety and ways of working culture, demonstrating respect and appreciation for diverse populations.
* Perform supporting GMP activities and troubleshooting for general lab operations, EM, facility testing as required.
* Execute in-process and drug substance analysis studies, leading/participating in laboratory projects.
* Introduce novel, innovative solutions, collaborating with the global Microbiology Center of Expertise and participating in lean lab methodologies.
* Organize and establish testing schedules, adhering to deadlines.
* Build team effectiveness skills, promoting team success through own actions and learning to communicate effectively.
* Be flexible to support changing business needs, providing out-of-hours support when necessary.
Education & Experience
A degree qualification in a relevant field (Biological Sciences/Engineering) is preferred, with an Advanced Degree (e.g., MSc) being desirable.
* A 3+ years' experience working in a relevant industry field.
* Technical knowledge with Biologics drug substance manufacturing and microbiological testing techniques.