Biotech Process Development Scientist - Hybrid - Dun Laoghaire

Biotech Process Development Scientist , Hybrid - Dun Laoghaire, Dublin

Office / Project Location : Dun Laoghaire, Dublin

Employment Type : Contract

Work Location :    Hybrid 2 / 3 days onsite per week

Pay :  €55 - €65 per hour

Experience : 5 + years

Visa :  EU passport or Stamp 4 visa required

Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin.

The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.

This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.

Process Engineer / Scientist required to work within the Process Development Commercial Support team based in Dun Laoghaire.

The team is responsible for providing process and product support to drug product formulation and fill-finish operations, as drug product process SMEs

1. Act as a drug product process development technical expert to provide swift and innovative solutions to complex challenges in drug product formulation, vial filling, pre-filled syringe filling, lyophilization and vial capping.

2. Key contributor to product and process investigations, responsible for assessing product and process impact.

3. Leads continuous improvement projects to improve process performance and productivity.

Assess product impact associated with proposed changes to commercial processes under the change control process.

Generate product impact assessments associated with process excursions and deviations, with reference to product technical documentation.

Support new product introduction team, as a process subject matter expert; This would include but is not limited to, recipe development and protocol execution, as well as troubleshooting and investigation support.

Review and approve changes to operating procedures, electronic batch records, and product documentation.

Identifies and implements operational opportunities for current and new sterile operations

Risk assessments and mitigation projects relating to line performance.

Perform process gap analysis and developing strategies to close gaps.

Data trend analysis for all performance aspects of the area.

Troubleshooting performance trends.

You will work in a collaborative manner within the process teams structure and contribute as a member of cross functional teams within the local organization and functional team globally.

Requirements

Bachelor’s or Masters degree in Engineering, Science or related discipline with 6 years experience in a similar role OR PhD and 3 years of directly related experience.

Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.

Typically 4-6 years drug product experience in areas such as drug product formulation, vial / pre-filled syringe filling or lyophilisation

Qualification in Lean and 6-sigma methodologies would be an advantage.

New product introduction (NPI), process development, MSAT experience in a GMP environment would be advantageous.

Experience in the Product Side

Process Development Experience – New Tech Transfer

Product and process investigation support – deviation or non-confirmative experience

Continuous improvement projects to improve process performance and productivity

New product introduction or process improvement experience in a GMP environment would be advantageous.

Experience in NPI or process development is sought after.

We would like to see Scientist applying for the position.

Package

Contract role - Hourly rate €55 - €65 per hour

Minimum 12 month contract with the possibility of an extension.

Onsite expectations : 3+ days per week.

We can provide flexibility in which days are onsite – it’ll be in line with the rest of the team.

There are weekly meetings with the immediate team on Wednesdays and Friday mornings are usually virtual meetings with the wider department.

Core hours : 08 : 30 to 17 : 00.

Shift : 20% ad-hoc shifts and support the business