Tech Transfer Lead Senior 28826A
⦁ JobTitle: Tech Transfer Lead Senior 28826A
⦁ About Company: Our client based in Dun Laoghaire is seeking a Tech Transfer Lead Senior to join its expanding team.
⦁ Duration of Role: 12 months
⦁ Summary Objective: This role will require the candidate to provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes at ADL. The candidate will establish themselves in a product lead role where the majority of input provided will be leading of process performance qualification (PPQ).
⦁ Job Duties:
• 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.
SKILLS AND REQUIREMENTS (no visa processing)
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.
•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.
Benefits of working with Independent Solutions
> Excellent Team of Colleagues
> Access to high-value projects
> Excellent Technical Project Managers
> Excellent pay & conditions
Independent Solutions are Approved Suppliers for Multinational Pharma Biotech, Medical Device, clients with locations based here in Ireland.
At Independent Solutions, we will not require you to become an employee of Independent Solutions, we will facilitate and support you to become an independent contractor, thereby reaping the maximum rewards from your contract role.
We work in the area, we know the business, we are not a recruitment agency!
We continue to partner and grow our client base and thereby ensure that we have continuous supply of excellent roles
Yes, of course we benefit from having YOU with US, but we can assure YOU that YOU too will benefit
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Tel: +353 1 5311 280
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