Job Overview:
This role involves leading and facilitating the safe operations of a 24/7 manufacturing team in a bio-pharmaceutical processing facility.
The successful candidate will have experience in batch processing, automation, commissioning, and validation in an FDA/HPRA regulated industry.
A minimum of 3 years' experience is required, as well as a 3rd-level qualification in a Science, Engineering, or related scientific field.
* Key Responsibilities:
* Lead and facilitate the safe operations of the manufacturing team.
* Act as key point of technical contact for aseptic fill finish activities.
* Supervision and execution of compounding, filling, lyophilization, equipment preparation, formulation, buffer preparation, and support processing activities.
* Liaise with program management, supply chain, technical operations quality, and engineering groups to ensure effective planning, scheduling, and execution.
Required Skills:
* A minimum of 1 year's direct supervisory experience in a team environment.
* Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry.
* Comprehensive understanding of the principles of contamination control and regulatory expectations for aseptic processing.
About Us:
We are an Equal Employment Opportunity Employer and value diversity in our workforce. We offer a dynamic work environment where individuals can develop innovative solutions for patients.