Job Description

Note: **All applicants must hold a valid visa to work in Ireland**

Overview:

This role will require the
candidate to provide process development support primarily to the Forensics and
Defect Laboratory. The candidate will establish themselves as an expert in
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.

Responsibilities would include the following:

         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.

         Working as part of the PD laboratory team be
expected to contribute to upkeep / maintenance of a GMP laboratory environment.

         Provide process development expertise for
commercial drug product particle / defect identification and contribute to the
maintenance of local and global particle / defect libraries.

 

Key Responsibilities:

         Perform experiments, organise data and analyse
results with minimal supervision (in a GMP laboratory environment) to evaluate
product impact due to process variables encountered during drug product
manufacture.

         Creation, Management and Maintenance of Inspection
defect panels / sets.

         Execution of Knapp studies and data analysis.

         Establish experimental design, develop and
implement protocols, obtain reproducible and reliable results and communicate
data to cross functional groups.

         Ensuring all aspects of laboratory activity
adheres to required policies and procedures, including safety and training.

         Ensure that the laboratory and site meet the
quality requirements of its customers and applicable regulations (FDA, EU &
international standards).

         Participate in cross functional teams at the
site to ensure adherence to required policies and procedures and be responsible
to deliver against organisational goals and project milestones.

         Assist in deviation and exception resolution and
root cause analysis.


Requirements

Basic Qualifications:

         Third level bachelor’s degree in science,
engineering or a relevant quality discipline with 2 – 4 years’ experience in a
similar role OR Associate’s degree and 5 years of directly related experience.

         Experience in Working in a Laboratory
Environment.

         Knowledge of cGMPs and other worldwide
regulatory requirements.

         Problem solving ability and excellent oral and
written communications skills. 

Preferred Qualifications:

         Masters in Science or Engineering.

         Experience in support of Commercial Protein Drug
Product (DP) processing in specific areas such as sterile processing, process
characterization, inspection, tech transfer (to commercial DP sites) or
validation.

         Be familiar with advanced microscopy (scanning
electron microscopy) and spectroscopy (Fourier-transform infrared
spectroscopy).

         Understanding of degradation mechanisms for
biologics, analytical methods, laboratory practices, and basic statistical
methods.

         Project management skills including the ability
to manage multiple projects and evaluate project resource requirements.

         Strong knowledge of Quality systems, Drug
Product Manufacturing and Validation.

         Demonstrated ability in providing leadership to
cross-functional teams to advance complex projects to completion.

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