Lead Biotech Associate-Shift

PSC Biotech® Corporation; Dunboyne; On-site; EUR 85,000 - 110,000; Full time

Job summary

PSC Biotech Corporation, a leading Biotech consultancy, seeks a contract Lead Manufacturing Biotech Associate to drive biologics production on a designated shift. You will coach a self-directed team, coordinate with the shift lead and engineer, and progress automated recipes in a GMP environment.

The role emphasizes lean processing, safety, and right-first-time delivery, with opportunities to lead improvement projects and mentor peers across the site.

Qualifications

• Bachelor’s degree in a technical, engineering or science discipline is required.
• Minimum 5 years’ experience in the biopharmaceutical industry.
• Strong leadership abilities and track record of delivering results.
• Thorough knowledge of current Good Manufacturing Practices (cGMP).
• Able to lead teams and manage projects under pressure.

Responsibilities

• Produce biologic drug substance on designated shift, coaching the team.
• Lead self-directed work teams and liaise with shift lead and engineer.
• Progress automated recipes using paperless technology for GMP production.
• Set up single-use equipment and ensure compliance with world-class GMP/EHS.
• Drive safety culture, right-first-time delivery, and continuous improvement.
• Coach peers in unit operations and sponsor approved improvement projects.
• Act as primary delegate for the shift lead during emergencies.

Skills

Leadership

Problem solving

Team mentoring

Process optimization

Lean processing

GMP knowledge

Education

Bachelor’s Level 8 degree in technical/engineering/science

Job description

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

'Take your Career to a new Level'

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the \"heartbeat\" of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client's expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Overview:

• A fantastic and exciting opportunity has arisen for a contract Lead Manufacturing Biotech Associate


• The Lead Manufacturing Biotech Associate will work across the site self-directed work teams and hub teams to identify and resolve issues in order to allow the site to deliver on our commit culture that support Quality, EHS, Learning and Continuous improvement. Reporting to the Downstream Shift Lead, this role is a critical role on the manufacturing team, with responsibility focused on a team-based commitment to batch progression and technical SME knowledge.


• This individual, being the most senior member of the shift suite operations team, will take ownership of the direct activities occurring within a suite. The lead BioTech Associate will act as point person for the progression of the batch, liaising with the Manufacturing shift lead and shift engineer on team delivery throughout the shift. The role will involve project management and problem solving of issues as they occur and also SME involvement in new projects on behalf of Manufacturing, training and development of new employees and ensuring the operations area is at the standard required. The Lead BTA will act as primary delegate for the manufacturing shift lead with responsibility for ensuring the finite schedule is delivered in a safe and compliant manner.

Requirements

What you will do:

• 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 culture including a 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 in alignment with the site strategies.


• Act as primary delegate for the manufacturing shift lead during emergency events.

What skills you will need:

• 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.


• Shift role: 3-2-2 at first, later 4-on/4-off