Biotech Associate

PE Global; Leinster; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Shift allowance

Job summary

Dunboyne Biologics is seeking a contract Lead Manufacturing Biotech Associate to oversee shift-based operations, drive batch progression, and deliver on safety and quality standards.

Reporting to the Downstream Shift Lead, you will mentor the shift team, manage projects, and push continuous improvement while ensuring regulatory compliance on a 24/7 onsite schedule with a 33.33% shift allowance.

Qualifications

• Bachelor's Level 8 degree in technical/engineering/science.
• Minimum 5 years in biopharmaceutical industry.
• Strong leadership and problem solving.
• Thorough knowledge of cGMP and biologics operations.
• Team player with proactive approach.

Responsibilities

• Produce biologic drug substance on the designated shift; act as coach and technical contact for the shift team.
• Lead troubleshooting and direct self-directed teams in processing area.
• Progress automated recipe using paperless technology to generate drug substance via filtration and purification.
• Set up single-use equipment between runs; perform production per GMP/EHS standards and drive improvements.
• Deliver on safety and right-first-time; develop self and peers within the team.
• Coach peers on unit operations as required to support value stream.
• Lead approved projects and continuous improvement initiatives aligned with site strategy.
• Act as primary delegate for the shift lead during emergencies.

Skills

Bachelors 8+ degree

Biopharma experience

Leadership

cGMP knowledge

Teamwork

Education

Bachelors 8+ in technical/science

Job description

*** This is a fully onsite position and will involve working shifts on a 24/7 basis (33.33% shift allowance). Please only apply if you are comfortable with this arrangement ***

A fantastic and exciting opportunity has arisen for a contract Lead Manufacturing Biotech Associate at Dunboyne Biologics.

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.

What you will do:

Bring your energy, knowledge, and innovation to:

• 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 Dunboyne 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.

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