Role Title:
Upstream Associate Scientist
Role Type:
12 month Contract
Location:
Dublin 15
We are seeking to recruit an Upstream Associate Scientist as part of Manufacturing Science and Technology to support the commercial manufacturing of biopharmaceuticals in the area of cell culture at a Biopharmaceutical Manufacturer in Dublin 15. Responsibilities will include design, execution and analysis of media, seed train, bioreactor and harvest experiments and their interpretation to support commercialization and GMP manufacturing implementation.
The successful candidate will be a key contributor to a dynamic and highly technical global team. 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 be a member of cross-functional teams addressing critical business objectives.
Key Responsibilities:
• Support commercial and product technical transfers including late-stage process characterisation programs.
• Design and execution of experiments with an ability to interpret data in upstream cell culture to support NPI, process characterisation and site operations.
• Media preparation and development supporting lab and manufacturing upstream processes.
• Preparation of laboratory operating procedures, study protocols and reports.
• Work independently or participate in cross-functional teams to meet high-visibility critical business objectives. Contributes to cross functional team (Manufacturing, QA, QC, Regulatory, Supply Chain, etc) for facility fit activities, specification changes, technical assessments, alternate vendor qualifications, change management.
• 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.
• Knowledge of cGMP compliance, site and regulatory agency requirements.
• May provide process subject matter expertise for regulatory inspections, filings and other interactions with regulatory agencies.
• Contributes to 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:
• An MSc. in Biological or Chemical Sciences/Engineering is preferred or BSc. with 2-5 years of industry and/or academic experience.
• Practical knowledge of cell biology, protein expression, protein structure and function and experience with cell culture or fermentation laboratory activities.
• Candidates must possess good organizational skills and strong attention to detail.
• Demonstrates ability to troubleshoot, interpret and discuss data.
• Demonstrates ability to identify scientific/operational gaps and identify potential solutions.
• Be self-motivated and work independently under minimal supervision.
• Critical qualities include a high degree of initiative, good verbal and written communication skills, and the ability to work in a team environment while being able to prioritize.