Analytical Science and Technology ScientistApply Now Email Me Job ID SR0032983 Date posted 02/07/2019 Location:Dunboyne, Ireland
This role will serve as an Analytical scientist within the Global testing Laboratory at the new single use multi-product biotech facility in Dunboyne, Ireland. This facility will manufacture enzyme replacement and antibody-based therapies for Takeda Biologics. This role will be responsible for providing Analytical expertise to support the Global testing laboratory for Biologics, provide assistance with Quality Control (QC) method validation and analytical transfers, assist in the authoring of regulatory submissions, and lead investigations and problem solving activities with site QC teams and partners from global QC. This is a critical role within the Quality Control organisation to help create value for our patients.
Essential Duties and Responsibilities
- Support the establishment of the QC function as a ‘Global testing centre of excellence’ for on site and network testing programs.
- Provide analytical technical expertise and oversight within the Quality Control laboratories, to ensure the delivery of product to patients,
- Act as the technical expert to support new method introduction and continuous analytical innovation in the laboratories.
- Assist in the execution of cGMP compliant and timely transfer of analytical methods into the Quality Control laboratories at the Dunboyne site (Analytical, Biochemical, Cell Biology, Microbiology and Raw Materials).
- Act as local Subject Matter Expert (SME) for relevant global procedures (e.g. Method validation and transfer, control chart trending, handling of investigations)
- Assure cGMP compliant and timely implementation and maintenance of validated status of assays.
- Support Regulatory Audits and assure inspection readiness.
- Identify, lead and drive improvements or remediation for analytical Assays (OOS, CAPA, etc).
- Support global harmonization and simplification.
- Responsible for adhering to domestic and international GMP regulations, cGMP’s, company policies, leadership behaviours, performance and budget management.
- Support an environment of right first time in everything that we do through a focus on principles of lean, including simplication, standard work, visual management and a learning organisation.
- Act in compliance with legal, EHS and allTakeda policies and procedures which are applicable to the site.
- Supprt fulfilment of key performance indicators.
- Adhere to safety standards to ensure a safe working environment while ensuring the laboratory is kept clean, tidy and safe at all times.
- Provide hands-on guidance and training when needed.
- Contribute to a team setting within the laboratory and project activities and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
- Ensure area is maintained in a GMP state at all times while following all EHS and 5S guidelines.
- Apply Lean principles such as 5S throughout daily work activities.
- Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.
- Champion site metrics to ensure targets are achieved and counter measures in place when applicable.
- Promote and exhibit Takeda Values.
Education and Experience Requirements
- A Ph.D. in a technical discipline is required (e.g. biochemistry, chemistry, Analytical science, cell biology).
- Experience in the biotechnology and/or pharmaceutical industry, with Operational experience of quality laboratories.
- Experience of analytical transfer programs and method development/validation.
- Proactive at keeping current with literature and latest technologies.
- A background in analytical methods (PCR, HPLC, ELISA, SDS-Page, Glyco analytic, Bio-Assays, PCR, capillary electrophoresis and compendial assays).
- Knowledge of Analytical Method Development, Analytical Method Validation and Statistical Quality Control is desired.
- Basic understanding of GMP, ICH, USP and global compendia regulations and guidance's, particularly as related to analytical method development and validation.
- Experience in problem solving (facilitation and application of tools), risk management and decision making.
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 Contol operation.
Internal and External Contacts
- For product quality, collaborates with Process Development Technical Services (PDTS) and Manufacturing Operations but is responsible for providing information to support the Quality Leadership decision.
- For quality and compliance, collaborates with the Quality Leadership Team 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 Environmental Health and Safety (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 the Quality Department.
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.