Bio-assay Principal Scientist, Process and Analytical Development - Ireland
Want to know company name or location? Company managed [?]
- 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