Bioprocess Operator @ VLE Therapeutics

Uniting Holding; Dublin; On-site; EUR 60,000 - 90,000; Full time

Job summary

VLE Therapeutics is building a new Irish-owned biomanufacturing facility focused on vaccines, advanced therapeutics and biologics. The Bioprocessing Operator will contribute to GMP production in a fast-paced, cross-functional team environment.

You will operate clean room equipment, perform inoculum and cell culture work, and support purification and fill/finish processes while adhering to strict quality and safety standards. English fluency and strong MS Office skills are required.

Qualifications

• More than 5 years of experience in cGMP Pharmaceutical Operations is essential.
• More than 3 years of experience in Drug Substance Biologics manufacturing is essential.
• Aseptic operations experience is preferable.

Responsibilities

• Operate equipment and run processes in a clean room environment according to batch records, manuals, parameters and GMP procedures.
• Perform equipment preparation, cleaning, inoculum handling, cell culture and DSP operations (purification, chromatography, Drug Substance Final Fill).
• Conduct filter integrity testing and aseptic operations.
• Adhere to safety, quality and environmental requirements and report adverse events.
• Troubleshoot equipment issues and respond to non-standard events as needed.
• Monitor and collect data on critical parameters and communicate up to supervision/technical support.
• Perform sampling and testing with analytical equipment and environmental monitoring.

Skills

Cross-functional collaboration

Independent initiative

Leadership

Education

Leaving Certificate

Science degree (L7/L8)

Tools

MS Excel

MS Word

Job description

Bioprocessing Operator

About VLE Therapeutics

Powered by transformation research in APC, VLE Therapeutics Ltd was formed to extend the value chain and deliver science and digital led manufacturing of Vaccines and Advanced Therapeutics. VLE Therapeutics will support the GMP manufacturing of clinical and commercial vaccines, next generation biologics & advanced therapeutics and aims to transform the time and cost associated to produce medicines for our clients.

This will be the first Irish-owned facility expressly designed to provide Ireland and Europe with a local supply chain for these critical medicines.

To create the best client experience, we will create & implement a seamless handover process from APC process development into GMP manufacturing, leveraging our novel platforms to deliver a Molecule-2-Market accelerator.

Stage 1

At our current APC facility, we are constructing a new state of the art biomanufacturing facility. Operations will employ cutting edge technology including single use equipment & disposables and deploy digital solutions to support the best client experience.

Stage 2

In parallel, we are planning the development of abespoke 80,000ft2 greenfieldGMP manufacturing facility, which will provide a world-class platform for the manufacture of a wide range of vaccines next generation biologics & advanced therapeutics for our clients globally.

Key to enabling our strategy is to create the best culture, the right values & behaviours and as a result, the establishment of a high performing team committed to creating a culture of excellence in everything we do.

Position Summary

Principal Responsibilities

• Demonstrate high performance behaviours, ability to work collaboratively within a cross functional team, ability to show independent initiative, to have a focus on continuous improvement and have a strong belief in supporting the right culture in the business.
• Operate equipment and run processes in a clean room environment, in accordance with batch record, user manuals, design parameters, equipment qualification protocols and validation protocols and current standard GMP operating procedures.
• Execution of operational activities for GMP production such as equipment preparation, component cleaning, USP operations (Inoculum, cell culture) and DSP operations (purification, chromatography, Drug Substance Final Fill), Filter Integrity testing and aseptic operations.
• Adhere to compliance requirements (safety, quality & environmental) and ensure any adverse events are communicated/troubleshot appropriately.
• Be capable of understanding and responding appropriately to adverse events. Ability to react appropriately to non-standard events. Troubleshoot equipment issues, when necessary.
• Monitoring and collecting data (including input to an electronic system) on critical parameters to anticipate potential upsets and notifying supervision/technical support of same. Data is used to identify issues and/or make process improvements.
• Process sampling and sample testing with analytical equipment, pH, conductivity, cell counting, environmental monitoring and routine calibration of same.
• Receiving and verification of all raw materials. Equipment set-up. Parts preparation. Deactivation of waste i.e., Biowaste system or autoclaves.
• Logging safety and quality events in the appropriate systems, including initiating process deviations.
• Completion of all relevant training on associated Individual Training Plans to complete manufacturing activities in a GMP manner.
• Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved.
• Collaborate with other departments and represent Manufacturing in cross functional initiatives and meetings.
• Maintain good housekeeping and clean and sanitize classified areas as required.

Experience & Qualifications

• More than 5 years’ experience in cGMP Pharmaceutical Operations is essential.
• More than 3 years’ experience in Drug Substance Biologics manufacturing is essential.
• Vaccine manufacturing experience is preferable.
• Advanced Therapeutics (Cell & Gene Therapy) manufacturing experience is a positive.
• Aseptic operations experience is preferable.
• The role may operate on rotating shift position and may also involve some non-scheduled call-in time to respond to plant emergencies etc. and some scheduled call-in time to attend process operations.
• Must be able to read, write and converse in English.
• Must have good working knowledge of MS Excel and Word.
• Ability to work in an intense, fast-paced work environment.
• Ability to function, with guidance, in a rapidly changing environment while balancing multiple priorities simultaneously.
• Ability to work independently and as part of a team.

Education

• Leaving Certificate or equivalent at a minimum. L7 or L8 Degree in a scientific discipline or equivalent experience preferred.

VLE is committed to the principle of equal opportunity for all employees. All employment decisions at VLE are based on business needs, job requirements and individual qualifications, without regard to gender, ethnicity, age, religious belief, disability, sexual orientation, gender identity and/or expression, marital status, or any other status protected by Irish law.