Lead Bioprocess Associa

PE Global; Dunboyne; On-site; EUR 65,000 - 85,000; Full time

Job summary

PE Global is currently recruiting for a Senior Production Lead in a leading multinational Biotech client based in Dunboyne, Ireland. This is an 11-month contract position on a 4-cycle shift, offering hands-on production of biologic drug substance and leadership on the shift.

The role requires a Bachelor’s degree (Level 8) and at least 5 years in biopharma, with strong cGMP knowledge and a proven leadership track record in regulated environments. Visa sponsorship is not provided.

Qualifications

• Bachelor’s degree in technical, engineering or science discipline.
• 5+ years’ experience in biopharma.
• Proven leadership in a regulated environment.
• Strong knowledge of cGMP and biotech operations.
• Ability to work on a 24/7 shift pattern.

Responsibilities

• Produce biologic drug substance on the designated shift and coach the team.
• Lead problem solving and act as liaison for the shift lead.
• Progress automated recipes using paperless technology for drug substance production.
• Set up single-use equipment; perform production per GMP and EHS principles.
• Drive continuous improvement with lean processing techniques.
• Mentor peers in unit operations and sponsor approved projects.

Skills

Leadership

cGMP

Problem solving

Coaching

Shifts

Education

Bachelor’s Degree (Level 8)

Job description

PE Global is currently recruiting for a XX for a leading multi-national Biotech client based in Dunboyne.

This is an initial 11-month contract position working on a 4-cycle shift.

ROLE:

• The production of biologic drug substance on their designated shift and act as a coach and a technical point of contact for others on the shift team, acting as a key liaison for the manufacturing shift lead for ongoing operations in a process area.
• Trouble shooting and problem solving in conjunction with the ability to lead the self-directed work teams in their processing area.
• The progression of an automated recipe using paperless technology in order to generate the drug substance through filtration and purification of the product.
• Setting up the single use equipment between runs, carrying out the production process according to world class GMP and EHS principles and driving to optimize and improve the processing activities through use of standard work and lean processing techniques.
• Focusing on delivery to the patient through living the site culture including commitment to safety, focusing on right first time in everything we do and concentrating on the engagement and development of self and peers.
• Act as a coach or mentor to one’s peers on specific unit operations as required to support the value stream
• Lead and sponsor approved projects and continuous improvement initiatives that are aligned with the site strategies.
• Act as primary delegate for the manufacturing shift lead during emergency events.

REQUIREMENTS:

• Minimum of a Bachelor’s Level 8 degree in a technical, engineering or science-based discipline or equivalent
• At least 5 years’ experience in the biopharmaceutical industry.
• Leadership Skills – demonstrated ability to lead and achieve outstanding results.
• Proven record of accomplishments in a regulated industry, thorough knowledge of current Good Manufacturing Practices (cGMP) and general technical and biologic operations understanding required.
• Ability to think logically and be proactive under pressure.
• Ability to work as part of a team and on own initiative in a constructive manner.
• This role is a site-based position. This role will involve working shifts, on a 24/7 basis.

Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland