Laboratory Business Systems Analyst

Job Description

This is a critical role within the Quality organisation to help establish the Laboratories as a hub for specialised analytical testing and create value for our patients.This role will support, from an analytical perspective, the Quality Control functional testing of incoming raw materials, in-process drug substance/drug product, final drug products, stability samples and environmental monitoring of the controlled manufacturing areas and utilities at the new single-use multi-product biotech facility in Dunboyne, County Meath, Ireland. This facility will manufacture enzyme replacement and antibody-based therapies for Takeda Dunboyne Biologics, the leading global biotech company focussed on rare diseases.

Responsibilities

This role is associated with the data management systems for instrument control in the laboratories, this includes but is not limited to Labware LES (LIMS + Execution System), Lonza MoDa, Waters Empower. Below activities are associated with these systems;

• Reviewing analytical data, analytical reports and performing peer reviews.
• Conducts thorough data review to ensure completeness and accuracy of records.
• Providing training for team members.
• Participates in defining user requirements
• Tests and validates the design
• Develops procedures and training documents
• Assist in the implementation at site
• Gather raw data for template building
• After vendor provided training will provide the first line of support within their laboratories
• Empower superuser to build and maintain custom calculation builds and system maintenance.
• Instrument qualification, maintenance and troubleshooting.
• Protocol generation– method verification/transfer.
• Following all relevant Standard Operating Procedures.
• Ensuring strict adherence to site policies, GMP and environmental, health and safety regulations.
• Complies with all pertinent regulatory agency requirements.
• Execution and on-time completion of required training activities.
• Reviews test results to ensure compliance with standards; reports any quality anomalies.
• Participates in Laboratory Investigations as required.
• Writes and revises control test procedures and SOPs as required.
• May interact with outside customers or functional peer groups.
• Promotes and exhibits Takeda Values.
• Executing company policies.
• Ensuring self -inspections are performed.
• Ensures new/revised quality system requirements are deployed to the Site.

Education and Experience Requirements

• A Level 8 Bachelor’s degree in a technical discipline (e.g. biochemistry, IT, engineering etc).
• Previous experience with Laboratory business systems or data analytics coupled with an interest in coding/ script is advantage
• Previous GMP laboratory experience in the biotechnology and/or pharmaceutical industry would be preferable.
• Excellent communication skills (written and oral).
• An understanding of cGMP requirements for manufacturing and/or systems and compliance.
• Required to work on his/her own initiative in addition to working as part of a team.
• Excellent time management & organisational skills.

Key Skills, Abilities, and Competencies

• Excellent trouble-shooting and problem-solving skills.
• Ability to challenge the status quo with a continuous improvement mindset.
• Promoting a culture where diversity and inclusion is part of the DNA.

Complexity and Problem Solving

• Identifying and communicating risks in area of responsibility and across the site.
• Creating strategies and plans to manage risk within the Quality Control operation.

Internal and External Contacts

• For product quality, collaborates with Manufacturing, Science & Technology (MS&T) and Manufacturing Operations but is responsible for providing information to support the QMR decision.
• For quality and compliance, collaborates with the QMR but accountable for creating a ‘right first time’ culture in the Quality group to support quality excellence.
• For safety, the individual is accountable to drive a culture of ‘everyone owns safety’ with input from the EHS lead.
• For continuous improvement collaborates with Business Excellence peers across the Biologics business unit in Takeda and through external forums to drive business excellence in Quality Assurance.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.