Job Title:
Bio Process Lead
Job Summary:
* We are seeking a highly skilled Bio Process Lead to support operational readiness activities and ensure facility design meets end-user requirements.
* The successful candidate will lead a team of professionals in the manufacture of biological products, adhering to highest standards of quality and regulatory compliance.
Responsibilities:
* Recruit, develop, and retain high performing team members to consistently deliver on specific Key Performance Indicators (KPIs) and meet customer expectations.
* Oversee plant and equipment operation to ensure compliance with Good Manufacturing Practice (GMP) regulations, site, and corporate quality standards.
* Provide technical support to manufacturing teams as required.
* Execute production activities to support training and development of personnel.
* Manage day-to-day operations on shift, ensuring functional area targets, objectives, and performance criteria are met.
* Align shift activities with changing business needs and prioritize tasks accordingly.
* Makes informed technical decisions where appropriate and escalates issues promptly.
* Work cross-functionally and cross-shifts to resolve issues and drive improvements.
* Responsible for schedule adherence metric on shift, driving performance to ensure throughput and changeover targets are met.
* Supports technical transfer activities and provides input on equipment installation, start-up, operation, and troubleshooting.
* Writes, reviews, revises, and approves area Standard Operating Procedures (SOPs), batch records, logbooks, training competencies, and work instructions.
* Seeks opportunities for Continuous Improvement using Lean/Six Sigma tools as part of daily operations.
Requirements:
* A degree in science, chemical engineering, or a related field is preferred but not essential.
* Minimum of 8 years supervisory/leadership experience in the pharmaceutical/biopharma industry in a direct manufacturing support role.
* Extensive experience in leading teams, supporting employee development, motivating, and engaging employees to achieve their potential.
* In-depth knowledge of relevant cGMP, safety, and environmental regulations.
* Expert knowledge and experience of manufacturing equipment and associated processes.
* Excellent knowledge of documentation standards and protocols in a pharmaceutical/biopharma manufacturing environment.
Skills: GMP Management Leadership GDP Benefits: Bonus Educational assistance Pension VHI
Benefits: We offer a competitive package including bonus, educational assistance, pension and VHI benefits.
Other Opportunities: Continuous Improvement is key to our success. We encourage you to seek out opportunities to improve processes and share your ideas.