i-Pharm Consulting

Sr Tech Transfer

Location
Dún Laoghaire
Salary
Negotiable
Posted
10 Jan 2019
Closes
24 Jan 2019
Ref
BT078
Discipline
Manufacturing
Contract Type
Contract
JOB TITLE
Senior Tech Transfer Lead – 12+ month contract

THE COMPANY

One of the top Pharmaceutical companies in the world. The organisation is seeking a talented indivdual with experience in 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. This is an excellent opportunity for someone looking to progress their career in Pharmaceuticals working within a global company.

LOCATION

Dun Laoghaire, Ireland

SALARY
Up to 54€ per hour

ROLE/DESCRIPTION

* 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.



EXPERIENCE NEEDED

* 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 & 10 years of directly related experience.
* Knowledge of cGMPs and other worldwide regulatory requirements.
* Problem solving ability and excellent oral and written communications skills.
PREFERRED

* Doctorate or Masters in Science or Engineering.
* 3+ 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.
* Knowledge of Quality systems, Drug Product Manufacturing and Validation.

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY:
If you would like to discuss this vacancy further, please call the Global Strategic Delivery Consultant Billy Twomey on +44 (0)20 3189 0460. If this role is not suitable, Billyis also available to discuss other possible positions or answer any general questions regarding your career and the current market.

KEY WORDS
Tech / Tech Transfer / Tech Transfer Lead / Senior Tech Transfer Lead / Biotech / Biotechnology / Pharmaceuticals / Pharma / Ireland/ Dun Laoghaire/

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