Team leader QC mRNA at Thermo Fisher Scientific

Monza, Lombardy, Italy

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalIndustries

Requirements

Master degree in Life Sciences or Chemical/CTF/Biological Engineering
Experience in common chemical analysis such as HPLC, GC, IR, UV-Vis, LC-MS, physical tests etc., with strong experience in chromatography and spectrophotometry
Experience in cleaning validation/verification methods
Ability to develop, transfer, qualify and validate analytical methods
Experience in troubleshooting
Ability to use pharmacopeia monographs and global pharmacopoeia (mainly EP/USP) for compendial incoming materials
Ability to apply GMP regulations and international guidelines to all aspects of the position
Experience in a QC GMP Laboratory, including documentation, reports, and exception management
English and Italian languages (professional knowledge)
Experience with Gene Therapy / Plasmid DNA / mRNA products - preferred
Experience in a QC position within the biological, chemical or pharmaceutical industry (or combination of an advanced degree and quality experience)
Ability to plan and organize analytical activities to guarantee respect of timelines agreed internally and with clients, maintaining high quality levels and GMP standards
Team management skills: coordinate the team, giving value to positive results and evaluating the need of training and development
Commitment and high motivation

Responsibilities

Provide leadership, scientific, compliance and technical expertise
Schedule activities of the team to meet project timelines
Ensure safe environmental and working conditions in the QC Laboratories
Support implementation of method qualification/validation protocols, reports and documents, and ensure their management according to current GMP, SOPs and guidelines
Direct contact with clients on specific projects
Serve as Team Leader of chemical/biochemical analysts and technicians in the mRNA QC Lab
Responsible for hiring, training, goal setting and performance evaluation of the team

Skills

Key technologies and capabilities for this role

HPLCGCIRUV-VisLC-MSChromatographySpectrophotometryCleaning ValidationMethod ValidationGMPPharmacopeiamRNA QCGene Therapy

Questions & Answers

Common questions about this position

What degree is required for the Team Leader QC mRNA position?

A Master's degree in Life Sciences or Chemical/CTF/Biological Engineering is required.

What technical experience is needed for this role?

Experience in chemical analysis such as HPLC, GC, IR, UV-Vis, LC-MS, physical tests, strong chromatography and spectrophotometry, cleaning validation, method development/transfer/qualification/validation, troubleshooting, pharmacopeia monographs (EP/USP), and GMP laboratory work including documentation and exception management is required.

What are the key soft skills for this team leader role?

Ability to plan and organize analytical activities to meet timelines while maintaining GMP standards, and team management skills to coordinate the team, recognize results, and support training and development are essential.

What responsibilities does the team leader have in managing the QC team?

The team leader schedules team activities, hires, trains, sets goals, and evaluates performance for chemical/biochemical analysts and technicians, while ensuring safe conditions and GMP compliance.

What makes a strong candidate for this position?

Candidates with a Master's degree, QC GMP lab experience in biological/chemical/pharmaceutical industries, technical expertise in chromatography and method validation, team management skills, and preferably experience with mRNA products stand out.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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