
Website TPM04989
Summary:
Our client, a biopharmaceutical company located in Cork, is looking for a MSAT Associate Scientist to join their team. The ideal candidate will be focusing on small-scale cell culture and fermentation activities and/or purification processing in the Biologics Centre of Excellence laboratory associated with the commercial manufacturing processes for a range of commercial products. The successful candidate will support process characterization, scale down model development, troubleshooting of complex manufacturing deviations, and continuous process improvement activities.
Responsibilities:
- Technical transfer, development and/or optimisation of small-scale models for cell culture or purification commercial processes.
- Design and conduct laboratory studies to support commercial manufacturing of recombinant enzymes and proteins.
- Studies include but are not limited to; process optimization & robustness studies, resin qualification, new technology evaluation, exploration of process analytical technologies.
- Knowledgeable in protein science, cell biology and protein expression.
- Readily share technical knowledge and experience with the wider MSAT team and support students/graduates with their laboratory skills development.
- Provide technical and investigations support for ongoing cell culture/purification processes at laboratory and manufacturing scale.
- Work cross-functionally with manufacturing, quality, CMC to secure consistency of drug substance supply to our patients.
- Work independently and within a team to maintain daily laboratory operations and actively communicate risks, setbacks and successes to internal stakeholders.
- Work with other MSAT scientists locally and globally to identify knowledge gaps and provide solutions to increase process understanding.
- Effective execution of experiments and basic problem solving with thorough documentation of experiments and results.
- Ability to perform data analysis and interpret and present results. An interest in Advanced Data Analytics with experience in RStudio, JMP, DoE would be desirable.
- Demonstrated excellent verbal and written communications skills and ability to handle multiple tasks with good organizational skills.
- Collaborate locally and globally, practice open & regular communication with key stakeholders within and outside of our client including Process Sciences, Analytical Chemistry, Manufacturing, Quality, Validation, Quality Control, and Facilities Services.
- Adhere to all site safety, environmental and industrial hygiene procedures and practices.
- Play an active role in maintaining and enhancing the safety of the workplace and the laboratories.
- Prepare SOPs, reports and documents such as characterization protocols, development reports, and testing results data reports.
- Coordinate routine preventative maintenance for laboratory equipment.
- Equipment related to analytical testing, as well as cell culture and/or purification equipment typical in biopharmaceutical labs and manufacturing.
- May be responsible for managing one or more associate scientists.
Qualifications & Experience:
- Bachelor’s degree in biochemistry, biotechnology or similar with 3-5 years relevant experience in process development, manufacturing sciences or commercial manufacturing.
- Masters or PhD qualification in a relevant technical area would be an advantage.
- Experience working within a regulated or pharmaceutical environment would be desirable.
- Experience with mammalian or microbial processing and/or purification technologies.
- An interest in Advanced Data Analytics and Design of Experiments with experience in RStudio, SAS, JMP etc would be desirable.
To apply for this job email your details to lara.miranda-pinto@tandempm.ie.