Mrna Process Development Scientist

Thermo Fisher Scientific; Monza; In loco; EUR 40.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading company in the scientific field is seeking a Scientist to join their mRNA Process & Analytical Method Development Group. The role involves developing and optimizing methods for RNA and LNP processes, conducting experiments, and ensuring compliance with GMP standards. The ideal candidate will possess strong technical expertise in purification techniques and process development for therapeutics.

Competenze

• Experience with GLP and GMP compliance preferred.
• A high level of commitment and a track record of quality work.
• Ability to multi-task and prioritize to meet deadlines.

Mansioni

• Conduct feasibility assessments, technical consultations, training, and bench trials.
• Develop robust and scalable downstream processes for purifying nucleic acids.
• Support technology transfer to cGMP manufacturing and QC groups.

Conoscenze

Knowledge of main purification techniques used for drug manufacturing

Experience in process development for therapeutics

Familiarity with the process of developing mRNA products

Experience writing content for documentation

Proficient English and excellent social skills

Descrizione del lavoro

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Thermo Fisher Scientific Inc. is the world leader in serving science, with an annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing productivity in their laboratories, improving patient health through diagnostics or developing and manufacturing life-changing therapies, we are here to support them. Our global team delivers an unrivalled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

• Your Future Team

The Scientist joining the team will work within the mRNA Process & Analytical Method Development Group, developing and optimizing methods and transferring them to cGMP and QC groups. The RNA Process and Analytical Development team is a brilliant team of Scientists focused on RNA and LNP technologies.

Key responsibilities will include hands-on laboratory tasks, mRNA / LNP process characterization and development for new products, process improvement, and document drafting.

• Responsibilities
• Application of TFF for RNA and LNP downstream.
• Conduct feasibility assessments, technical consultations, training, and bench trials.
• Develop robust and scalable downstream processes at the laboratory scale to purify nucleic acids and LNP with liquid chromatography / TFF using DOE-based approaches.
• Scale up / scale down testing plans and data review, sizing, compatibility, and solving technical issues.
• Support technology transfer to the cGMP manufacturing and quality control (QC) groups for clinical material production / analysis.
• Perform routine bench work under limited supervision, prioritize responsibilities effectively, and complete timely assignments.
• Maintaining domain expertise in new technologies and scientific literature to drive innovation.
• Train junior scientists as needed.
• Qualifications
• Requirements
• Knowledge of main purification techniques used for drug manufacturing.
• Experience in process development for therapeutics with standard downstream purification techniques, including depth filtration, FPLC and TFF.
• Familiarity with the process of developing mRNA products would be a plus.
• Experience with GLP and GMP compliance and manufacturing preferred.
• Experience writing content for documentation, including SOPs, work instructions, technical protocols and reports, and technical presentations.
• A high level of commitment and a track record of quality work, with attention to detail.
• Capable of presenting the work clearly among the team.
• Ability to multi-task and prioritize to meet deadlines.
• Ability to respond quickly to evolving priorities.
• A self-starter and a great teammate.
• Proficient English and excellent social skills.
• Highly desirable
• Expertise in upstream processing, including experience with bioreactors at small, intermediate, and large scales; development of scale-up and scale-down models; and bio reactions optimization.
• Technical expertise in mRNA synthesis by enzymatic method development.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will be considered for employment without regard to race, creed, religion, colour, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age, or disability status.