Process Development Scientist - Dun Laoghaire, Dublin

Office/Project Location: Dun Laoghaire, Dublin

Employment Type: Contract

Work Location:  On Site Lab based

Pay: €35 - €45 per hour

Experience: 3+ 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.

This role will be responsible for supporting activities related to the Forensics and Defects group operating within the Commercial Attribute Science / CAS team as outlined below.

Forensics & Defects activities involving forensic identification of Drug Product defects and maintain and produce extensive defect panels used to support automated and manual visual inspection of vial (liquid / lyophilised) and syringe packaged drug products.

You will have proven experience acquired in the Pharmaceutical Industry, have a right first-time mindset, be a team player, have excellent communication skills and be focussed on delivering on our customer needs.

The successful candidate will also have a strong understanding of Data Integrity principles, Quality and Compliance in the laboratory as well as good presentation/influencing skills.

Leads / assists forensic investigation and identification of defects arising from drug product manufacture and write up of these investigations to cGMP standards.

Be accountable for the maintenance, distribution and upkeep of extensive defect panels used for the set-up, training and characterisation of automated / semi-automated / manual finished drug product visual inspection equipment.

Act as support for the Attribute Sciences function on cross functional teams/programs

Timely documentation of Analytical data in the electronic notebook system.

Understanding of data flow in laboratory systems and data integrity.

Participate in the peer review of analytical data.

Compliance with Standard Operating Procedures for the Attribute Sciences Laboratory.

Ensure the laboratory is operated in a safe and environmentally friendly manner.

Ensure ongoing compliance with phase appropriate GMP, including compliance within the LMS training system.

Ensure high levels of Laboratory housekeeping are maintained including inventory control of samples and consumables.

Ensure timely completion of Laboratory Investigations, Deviations , PMAFs

Participate in internal/external audits/inspections as required.

Plan and implement procedures and systems to maximise operating efficiency.

Manage and contribute to the achievements of department productivity and goals.

Engage with the Continuous Improvement Process and MyGreenLab® philosophy.

Requirements

Hold , at a minimum a third level qualification (Degree) in Analytical Chemistry/ Biochemistry or related discipline.

Have 3-6 years of experience in the Pharmaceutical Industry

Excellent written and verbal communication skills

Experience with Regulatory inspections and interaction with inspectors is preferable.

Experience working with teams and influencing decisions.

Skilled in the use of problem-solving tools/techniques

Experience with developing, validating, troubleshooting, analytical methods.

Understanding of the Change Control and Variation Management Process

Understanding how the use of statistical tools, such as multivariate analysis can aid troubleshooting.

Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.

Package

Contract role - Hourly rate €35 - €45 per hour

Minimum 12 month contract with the possibility of an extension. 

Onsite expectations: Expectation at the beginning is to be onsite five days a week because they’re ramping up. They will be ramping up training and ensure that the CW has all the tools necessary to operate independently. This will be the case for the initial first six-months – to be present in the lab. When the CW is working autonomously, there could be an opportunity to work one day a week from home. This will be for when the individual needs to write up a report and stuff like that.

Shift Rate: 20%

Shift Patterns: Two cycle shifts:

Week 1: 07:00 to 15:00 Mon – Thurs, 07:00 to 14:00 Fridays

Week 2: 14:30 to 22:30 Mon – Thurs, 13:00 to 20:00 Fridays

Contact

Karen McHugh is the consultant managing this position.

If you are a Process Development Scientist interested in roles based in Dublin , you can contact Karen by e-mail at karen@jobcontax.com Karen or phone 353 1 7979720 for a confidential chat.

JobContax do not send CVs to clients without candidate permission.

With over 50 years of technical recruitment experience, JobContax is the leading recruiter of Process Development Scientists expertise in Dublin and Ireland.

Due to the large volume of applications, JobContax may not be able to respond to every individual.

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