support of Commercial Protein Drug Product (DP) processing in specific
areas such as sterile processing, process characterization, tech
transfer (to commercial DP sites) or validation?
This is a contract role based in Dun Laoghaire, Dublin.
BIOTECH TECH TRANSFER LEAD - DUBLIN
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 require the candidate to provide process development
support primarily to new product introductions (NPI) and lifecycle
management (LCM) changes.
You will establish themselves in a product lead role where the
majority of input provided will be leading of process performance
qualification (PPQ).
In addition, the candidate will be expected to provide technical
support to biologics drug product manufacturing as part of the global
Process Development organization.
Leads new product introductions from a Process Development perspective
and then serves as the Process Development SME for these products
following completion of the transfer.
Be accountable for success of the product transfer project from
initiation to the transfer, through line characterisation, engineering
studies, process performance qualification and ultimately to
regulatory approval.
Provide solutions when trouble shooting drug substance
freezing/thawing, formulation, filling vials/syringes/devices,
lyophilisation, inspection and transportation for parenteral products
through the NPI or post-NPI phases.
Provide process development expertise for commercial drug product
processing in specific areas such as sterile processing, process
characterization, tech transfer and validation.
Support commercial drug product manufacturing operations with
technical evaluation of Change Control/NC/CAPA and technology
transfer.
The position will report to Process Development Senior Engineer.
Moderate international travel might be required during the course of
the project.
Development of validation plans, process performance qualifications
for vial and syringe filling.
Ensuring all aspects of activity within any given process validation
adheres to required policies and procedures, including safety and
training.
Ensure that the site meets the quality requirements of its customers
and applicable regulations (FDA, EU & international standards) with a
full understanding of CMC business process related to technology
transfer.
Participate in process validation cross functional teams at the site
to ensure adherence to required policies and procedures and be
responsible to deliver against organizational goals and project
milestones.
Pre-approve and post-approve process validation protocols and
assessments from a quality system documentation perspective.
Actively communicates across functions and sites and is a strong
collaborator with all the functional groups at the receiving site,
sending site and corporate functions.
Act as the responsible point contact from ADL site for the transfer
project for drug product teams and Global Operations Teams.
Assist in the development of any existing validation program to ensure
continued compliance to the necessary regulations and input to site
validation guidance documents.
Collate and report on relevant shipping and filter validation.
Assist in deviation and exception resolution and root cause analysis.
Contribute to product quality assessments and process flow documents.
REQUIREMENTS
Third level Bachelor’s degree in science, engineering or a relevant
quality discipline with 5 years experience in a similar role OR
Master’s degree & 3 years of directly related experience OR
Associate’s degree & * years of directly
related experience.
Knowledge of cGMPs and other worldwide regulatory requirements.
Problem solving ability and excellent oral and written communications
skills.
Product validation experience (not equipment validation).
Manufacturing experience.
Syringe / Vial filling / Process Validation / Performance
Qualification / PPQ Process Characterisation.
Biologic or protein manufacturing / if they have powder or tablet.
Please note: think people getting equipment and process mixed up with
submissions based on past submissions.
Not equipment which is product / process validation PE.
Need to know how the product works and how it works.
PREFERRED QUALIFICATIONS
Doctorate or Masters in Science or Engineering.
5 + years of experience in support of Commercial Protein Drug Product
(DP) processing in specific areas such as sterile processing, process
characterization, tech transfer (to commercial DP sites) or
validation.
Strong skills in applying fundamental engineering and scientific
principles to the design, implementation and process validation of
protein freeze-thawing, filtration, mixing, filling (PpK / batch
homogeneity) and/or lyophilisation processes.
Knowledge of protein biochemistry with regard to chemical and physical
stability.
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.
Excellent Communication skills are essential for this role.
PACKAGE
Contract role - Hourly rate € * - €**Apply
on the website** per hour
Minimum * month contract with the possibility
of an extension.
Onsite Requirements:
Core hours: *: * to
*: *.
Prepared to be onsite more regularly at the start to integrate into
the team.
Requirement long-term to be onsite 3 days per week & come onsite when
needed.
Shift Patterns:
Once every quarter there is a need to support shift works is based on
the support of PPQs and engineering runs.
As the business has changed, we will do more regular shift work and
will require the support from the team.
Shifts are 2 days on and 2 nights on and 4 days off and repeats like
that.
*: * and **Apply on the
website**: * pm and **Apply on the
website**: * am to **Apply on the
website**: * pm @ *%
shift rate.
We need : English (Good)
Type: Permanent
Payment: EUR 50 - 60 Per Hour
Category: Construction
