As a Technical Operations Specialist, you will play a key role in driving the implementation of commercial manufacturing production programs.
Key Responsibilities:
* Liaise with process science/technology transfer teams to facilitate transfers and startups of manufacturing processes.
* Provide technical input into manufacturing records, batch sheets, and procedures.
* Develop and review Standard Operating Procedures and other controlled documents.
* Solve process problems on and off the production suites in collaboration with cross-functional groups.
* Support manufacturing personnel in improving technical knowledge of critical process steps.
* Modify process method files through the quality system.
* Implement CAPA improvements and ensure compliance with protocols, regulations, and schedules.
* Communicate changes to supervisors and work cross-functionally with departments like Facilities, Engineering, and Regulatory.
* Represent manufacturing during audits and implement safety improvements.
* Pursue continuous improvement initiatives.
This role requires strong organisational, time management, and problem-solving skills, as well as excellent communication and interpersonal skills. The ideal candidate will be able to think critically and work independently in a fast-paced environment.
To succeed in this position, you must hold a degree in Life Sciences or a related field and have at least 2 years of GMP experience in a Drug Substance Biotech facility.