Scientist in mRNA Process Engineering

4 settimane fa

Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

Position Overview

We are seeking a skilled professional to contribute to our mRNA process development efforts. The ideal candidate will possess a strong background in biopharmaceuticals and demonstrate expertise in downstream processing.

Key Responsibilities

  • Utilize Tangential Flow Filtration (TFF) for RNA and Lipid Nanoparticle (LNP) purification.
  • Conduct feasibility studies, provide technical guidance, and perform training and laboratory trials.
  • Design and implement scalable downstream processes for nucleic acids and LNP purification using liquid chromatography and TFF, employing Design of Experiments (DOE) methodologies.
  • Develop and execute scale-up and scale-down testing protocols, analyze data, and troubleshoot technical challenges.
  • Facilitate technology transfer to cGMP manufacturing and quality control teams for the production and analysis of clinical materials.
  • Engage in LNP process development activities.
  • Perform routine laboratory tasks with minimal supervision, effectively manage priorities, and meet deadlines.
  • Stay informed on emerging technologies and scientific literature to foster innovation.
  • Provide mentorship to junior scientists as required.

Qualifications

  • Master's Degree in Life Sciences, Chemical, Biological, or Process Engineering with relevant experience in the biopharmaceutical sector, preferably in a process development role; or a PhD in Biochemistry, Chemistry, Chemical Engineering, Biological Engineering, or related fields with at least 2 years of post-doctoral or industry experience.

Requirements

  • Proficient understanding of primary purification techniques utilized in drug manufacturing.
  • Experience in therapeutic process development using standard downstream purification methods, including depth filtration, FPLC, and TFF.
  • Familiarity with mRNA product development is advantageous.
  • Knowledge of GLP and GMP compliance and manufacturing practices is preferred.
  • Proficient in creating documentation such as SOPs, work instructions, technical protocols, reports, and presentations.
  • Demonstrated commitment to quality work with meticulous attention to detail.
  • Able to communicate findings clearly within the team.
  • Capable of managing multiple tasks and prioritizing effectively to meet project timelines.
  • Responsive to changing priorities.
  • A self-motivated individual who collaborates well with others.
  • Fluent in English with strong interpersonal skills.

Highly Desirable

  • Expertise in upstream processing, including experience with bioreactors across various scales; development of scale-up and scale-down models; and optimization of bioreactions.
  • Experience with U/HPLC, FPLC, CGE, Ribogreen assay, and DLS methodologies.
  • Technical proficiency in enzymatic methods for mRNA synthesis.

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

Join us in our mission to enable our customers to make the world healthier, cleaner, and safer.

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