Tech Transfer Specialist

Description

The position requires effective cross-functional collaboration with external and internal partners including External and Internal Technical Services, Manufacturing Science & Technology (MS&T), Product Development and Clinical Supply (PDCS), Supply Relationship Management, External Manufacturing and Operations, Quality and Regulatory partners.

You will be responsible for:

• Developing and implementing TT Strategy including Process Validation, Control Strategy. This includes drug substance and drug product (biologic) and small molecule drug substance and drug product (eg oral solid dosage)
• Leading technical gap assessment & ensuring implementation of any associated mitigation activities.
• Authoring and reviewing project related documentation. Reviewing approving supporting protocols and reports.
• Ensuring site specific Cleaning Validation and Media Fill Strategy is aligned with Alexion global requirements.
• Provide SME input to technical aspects of IR response. Providing support to Regulatory audits as needed.
• Support the implementation of TT and Validation best practices across the network, work closely with other members of the ATO TT and Validation team on implementation of improvements.

Skills

• pharmaceutical
• technology transfer
• biologics
• process validation

Job Title: Tech Transfer Specialist

Location: Dublin, Ireland

Job Type: Contract

Trading as Aerotek. Allegis Group Limited, Maxis 2, Western Road, Bracknell, RG12 1RT, United Kingdom. No Allegis Group Limited operates as an Employment Business and Employment Agency as set out in the Conduct of Employment Agencies and Employment Businesses Regulations 2003. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, Talentis Solutions, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice.

To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to the website.

We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield.