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Bio-assay Principal Scientist, Process and Analytical Development Cork Ireland,
Posted on : 04 June 2017
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork
- As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- The Process and Analytical Development (P&AD) group require a Bio assay Principal Scientist with strong bio assay experience to provide multidisciplinary expertise and technical support to the P&AD team and commercial testing laboratories, in addition to being an active member within the wider Technology team.
- The successful candidate will be responsible for leading the effective and efficient running of Bio-assay Projects, Analytical Method Transfers and Validations.
- The successful candidate will be required to demonstrate a high level of technical leadership, collaboration, and coaching to facilitate the team in becoming a high performance organisation and ensuring timely delivery of projects.
- Central to this objective will be the active engagement and communication with all internal and external stakeholders.
- A high level of innovation, enthusiasm and drive will be required to deliver technical excellence for analytical method stabilization and process optimization studies which will deliver and maintain process robustness.
- Good knowledge of working practices required for working in a Bio-assay laboratory (e.g. good aseptic techniques, ELISA, cell biology, cell culture, protein biochemistry etc.)
- Support assay optimization/remediation within the Bio-assay area
- Participate in continuous improvement initiatives, including bio assay optimization/redevelopment and life cycle management
- Analytical Technology Transfer
- Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.
- Adherence to project timelines and use of project management tools
- Participate in cross-functional problem solving teams for troubleshooting, and investigations within Quality in Briny, other company Sites and contract laboratories as required.
- Commissioning and Qualification of various lab equipment and design and execution of assay and equipment validation studies and ongoing monitoring bio assay.
- Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.
- Actively pursue development opportunities to increase the skill set and experience within the group through continuous education, job rotation, cross-functional training, Lean Six Sigma, etc
- Collaborate with internal partners (i.e. other sites, R&D) and externally with CROs
- Actively Participate in a culture of Continuous Improvement and process optimization by deploying Six Sigma tools within cross functional.
- BSc in a relevant Science discipline
- Experience with ELISAs and leading analytical method validations
- Self-motivated and ability to work as part of a team with good project management Skills
- High level written and verbal communications with advanced PC skills
- Knowledge and experience of operating in a development and commercial lab environment
- Ph.D./M.Sc. qualification (Science)
- Knowledge of and experience in applying Six Sigma and Lean methodologies,
- Equipment commissioning and qualification
- Our employees are the key to our company s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
- Our company is an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.
Travel: Yes, 10 % of the Time
Job Segment: Biochemistry, Analytics, Scientific, Scientist, Lean Six Sigma, Science, Management, Engineering
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