- BBBH789083 Jul 30, 2021 Competitive
An opportunity has arised due to internal promotions, for a Snr Scientist to join a global technical team based in North Dublin. This state of the art facility offers significant room for progression.
This role will serve as a technical leader and subject matter expert to large/small scale chromatographic, filtration, ultrafiltration/diafiltration and other purification unit operations in support of GMP biopharmaceutical manufacturing.
This position will build collaborations with Process Development, Manufacturing, Manufacturing Support, Engineering, Quality Assurance and Global Regulatory Sciences groups. As part of MS&T, this position offers the opportunity to provide strong and highly visible leadership of cross-functional teams to address critical business objectives.
Key Duties and Responsibilities:
- Independently leads the design and execution of experiments with a demonstrated ability to interpret data in protein chromatography, viral inactivation, ultrafiltration/diafiltration, and filtration unit operations to support New Product Introduction, Process Characterisation, Optimisation and site operations.
- Matrix management of projects/activities within the team, prioritises and co-ordinates activities to ensure timely delivery.
- Troubleshooting of manufacturing process-related events and evaluation of new process technologies through the design of scale-down studies and the evaluation of data from manufacturing.
- Contributes to and/or leads cross functional team (Manufacturing, QA, QC, Regulatory, Supply Chain, etc) for facility fit activities, specification changes, technical assessments, alternate vendor qualifications, change management.
- Strong knowledge of cGMP compliance, site and regulatory agency requirements.
- Provides process subject matter expertise for regulatory inspections, filings and other interactions with regulatory agencies, representing the Cruiserath site.
- Contributes to and/or leads global network initiatives such as the evaluation of new technologies or the establishment of best practice approaches in area of responsibility
Qualifications, Knowledge and Skills Required:
- Minimum BSc or equivalent with a minimum 6-9 years relevant experience, MSc or equivalent with a minimum of 4-6 years relevant experience, Ph.D. with 2-4 years relevant experience, biological sciences or chemical/biochemical engineering.
- Experience in downstream manufacturing technical support or downstream process development in the biopharmaceutical industry.
- Demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.
- Experience with regulatory authoring (e.g. submissions, health authority responses) would be an advantage
- Proven project/matrix management skills, including leading cross functional teams and balancing project assignments.
- Interpersonal and facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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