pharmaceutical Laboratory running Chromatography methods (in a PD
and/or QC laboratory)?
This is a contract role based in Dub Laoghaire, Dublin.
If you have the relevant experience, please forward your CV to **Apply
on the website** for review or call * **Apply
on the website** to discuss in confidence.
PROCESS DEVELOPMENT SCIENTIST - BIOTECH - 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 into
Ireland&# *;s leading aseptic manufacturing
plant.
This role will be responsible for undertaking activities pertaining to
Chromatography Analytical Method Troubleshooting, Analytical Method
Lifecycle and Analytical support for process development activities at
the site.
You will have proven Chromatography experience acquired in the
Pharmaceutical Industry, have a right first-time mindset, be a team
player, have a strong understanding of customer service and work with
QC colleagues to effectively troubleshoot analytical issues.
You will also have a strong understanding of Data Integrity principles
and compliance in the laboratory as well as good
presentation/influencing skills (Influencing with Data/ Data
storytelling).
Proven experience with the use of statistical packages to aid
analytical method troubleshooting would also be a distinct advantage.
Chromatographic method troubleshooting and development (HPLC/UPLC –
CEX,SEC,RP,HIC,HILIC) .
Use of Empower CDS at an advanced level (ability to create report
methods, custom fields etc).
Experience with other analytical techniques would be an advantage
(Capillary Electrophoresis, KF titration, compendial methods).
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.
Responsible for providing technical guidance and applying expertise
and critical thinking to help resolve technical issues with analytical
methods in QC.
Qualification of analytical equipment and related testing functions.
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 a third level qualification (Degree) in Analytical Chemistry/
Biochemistry or related discipline.
Have 5+ years of experience in a pharmaceutical Laboratory running
Chromatography methods (in a PD and/or QC laboratory)
Strong background in General Analytical Chemistry/ Compendial
Techniques such as Appearance, Colour, Clarity, ph, Sub Visible
Particle testing, Osmolality, KF Titration is preferred but not
essential.
Possess key competencies to include planning/organisation, problem
solving, communication, teamwork, flexibility, coaching and
motivating.
Excellent written and verbal communication skills
Experience with Empower CDS at a poweruser/advanced user level.
Deep knowledge of chromatography hardware use and maintenance
practices
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, bridging
Chromatography methods.
Understanding of the Change Control and Variation Management Process
Understanding how the use of statistical tools, such as multivariate
analysis can aid method troubleshooting.
PACKAGE
Contract role - Hourly rate € * - €**Apply
on the website** per hour
Minimum * month contract
We need : English (Good)
Type: Permanent
Payment: EUR 25 - 33 Per Hour
Category: Construction
