working in a Laboratory Environment?
This is a contract role base in Dublin.
If interested, forward your CV to * or call
Karen on + *- * for a
confidential chat.
PROCESS DEVELOPMENT SCIENTIST - BIOTECH PLANT - DUBLIN
JOB DESCRIPTION
Our client is a leading international Biotechnology company with a
state of the art aseptic manufacturing facility in Dun Laoighaire,
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 on Ireland&#**Apply
on the website**;s leading aseptic manufacturing plant.
This role will require the candidate to provide Process Development
(PD) 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.
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.
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.
The position will report directly to Process Development Senior
Scientist.
REQUIREMENTS
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.
Excellent Communication skills are essential for this role.
Preferred Qualifications
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.
PACKAGE
Contract Hourly rate € * - €**Apply on the
website**. * per hour, €**Apply on the
website**. */hour with shift allowance
Shift allowance is *%
Minimum * month contract
2 cycle shift
week 1 - 7am to 3pm Monday to Friday
week 2 - 2. *pm to **Apply on the
website**. *pm Monday to Friday **Apply on the
website**% shift rate.
We need : English (Good)
Type: Permanent
Payment: EUR 30 - 34 Per Hour
Category: Construction
