experience in a similar role, (ie in a lead role, decision maker) and
have good knowledge of cGMPs and other worldwide regulatory
requirements?
This is a contract role based in Dun Laoghaire, Dublin
3+ days onsite, the rest work from home.
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.
TECH TRANSFER LEAD - BIOTECH NPIS - 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.
The position will report to Process Development Senior Engineer.
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, you will be expected to provide technical support to
biologics drug product manufacturing as part of the global Process
Development organization.
Leads new product introductions to site from a Process Development
perspective and then serves as the Process Development SME for these
products following completion of the transfer to site.
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.
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 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
*+ years experience Tech Transfer in a similar
role, (ie in a lead role, decision maker)
Knowledge of cGMPs and other worldwide regulatory requirement.
Product development, process/product design, develops and
characterizes drug product processes etc
Problem solving ability and excellent oral and written communications
skills.
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
3+ days onsite, the rest work from home.
Shift uplift *%
Minimum * month contract
Moderate international travel might be required during the course of
the project.
We need : English (Good)
Type: Permanent
Payment: EUR 50 - 57 Per Hour
Category: Construction
