Headcount Solutions is resourcing a Senior Tech Transfer Lead for our
multinational client&#**Apply on the website**;s biopharma facility in
Dublin.
Reporting to the Process Development Senior Engineer, this person will
provide process development support primarily to new product
introductions (NPI) and lifecycle management (LCM) changes at the
client site. The candidate will establish themselves in a product lead
role where the majority of input provided will be leading of process
performance qualification (PPQ). Lead new product introductions to the
site from a Process Development perspective and serve as the Process
Development SME for these products following completion of the
transfer to the site.
Main Responsibilities:
* 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.
* 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.
* Assist in the development of any existing validation program to
ensure continued compliance to the necessary regulations and input to
site validation guidance documents.
* Assist in deviation and exception resolution and root cause
analysis.
Requirements:
* Third level Bachelor&#**Apply on the website**;s degree in science,
engineering or a relevant quality discipline with 5 years&#**Apply on
the website**; experience in a similar role OR Master&#**Apply on the
website**;s degree & 3 years of directly related experience OR
Associate&#**Apply on the website**;s degree & **Apply on the
website** years of directly related experience.
* 5 years&#**Apply on the website**; experience in a similar role
(i.e. in a lead role, decision maker).
* Knowledge of cGMPs and other worldwide regulatory requirement.
* Ideally possess experience with product development, process/product
design, develops and characterizes drug product processes etc
* Highly desirable to possess 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.
To express an interest in this position please forward cv in
confidence to or, alternatively, please contact Mick on (phone number
removed) for further information Senior Tech Transfer Lead
Headcount Solutions is resourcing a Senior Tech Transfer Lead for our
multinational client&#**Apply on the website**;s biopharma facility in
Dublin.
Reporting to the Process Development Senior Engineer, this person will
provide process development support primarily to new product
introductions (NPI) and lifecycle management (LCM) changes at the
client site. The candidate will establish themselves in a product lead
role where the majority of input provided will be leading of process
performance qualification (PPQ). Lead new product introductions to the
site from a Process Development perspective and serve as the Process
Development SME for these products following completion of the
transfer to the site.
Main Responsibilities:
* 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.
* 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.
* Assist in the development of any existing validation program to
ensure continued compliance to the necessary regulations and input to
site validation guidance documents.
* Assist in deviation and exception resolution and root cause
analysis.
Requirements:
* Third level Bachelor&#**Apply on the website**;s degree in science,
engineering or a relevant quality discipline with 5 years&#**Apply on
the website**; experience in a similar role OR Master&#**Apply on the
website**;s degree & 3 years of directly related experience OR
Associate&#**Apply on the website**;s degree & **Apply on the
website** years of directly related experience.
* 5 years&#**Apply on the website**; experience in a similar role
(i.e. in a lead role, decision maker).
* Knowledge of cGMPs and other worldwide regulatory requirement.
* Ideally possess experience with product development, process/product
design, develops and characterizes drug product processes etc
* Highly desirable to possess 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.
To express an interest in this position please forward cv in
confidence to or, alternatively, please contact Mick on (phone number
removed) for further information
We need : English (Good)
Type: Permanent
Payment:
Category: Others
