Quality Control Analyst, seniority media - sostituzione maternità

ANEMOCYTE; Como; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

Anemocyte, a leading Italian biotech firm, is looking for a Quality Control Analyst for maternity cover. This role demands expertise in molecular biology and analytical method development, requiring a degree in a relevant field and at least 3 years in a similar position.

Competenze

• At least 3 years of post-university experience in a similar role.
• Operational autonomy in key molecular biology techniques.
• Knowledge of cGMP principles and European Pharmacopoeia.

Mansioni

• Manage biochemical, biological, and microbiological analyses.
• Develop and validate analytical methods.
• Prepare validation protocols and manage laboratory reagents.

Conoscenze

Molecular biology assays

Drafting protocols

Analytical method development

Precision

Organization

Formazione

Degree in chemistry-pharmacy/biotechnology

Strumenti

Microsoft Office

Software for data integrity

Descrizione del lavoro

Anemocyte, a leading Italian biotech manufacturing organization focused on development, production, and analytical services in the field of pDNA and mRNA, is seeking a QUALITY CONTROL ANALYST for maternity cover, with medium seniority level. The candidate will report to the QC Manager and collaborate with the team in executing and managing analytical activities, including biochemical, biological, microbiological, and molecular biology analyses. Responsibilities also include method development and subsequent qualification/validation phases. The role requires independence and expertise in developing, implementing, and fine-tuning analytical methods.

Minimum requirements:

• At least 3 years of post-university practical experience in a similar role.
• Good knowledge of molecular biology assays.
• Proficiency in Microsoft Office.
• Strong skills in drafting and reviewing protocols and procedures.
• Degree in chemistry-pharmacy/biotechnology.
• Operational autonomy in key molecular biology techniques (DNA extraction, Primer design, PCR, qPCR, sequencing analysis, etc.).
• Experience and independence in performing LAL tests for bacterial endotoxins detection.
• Precision, organization, deadline adherence, and proactive attitude.

Valuable additional skills:

• Knowledge of cGMP principles, guidelines, and European Pharmacopoeia.
• Basic knowledge of English language.
• Understanding of ISO 9001 standards.
• Knowledge of regulations for advanced therapy medicinal product manufacturing.
• Analytical expertise in mRNA characterization techniques.

General tasks include:

• Preparation of media and management of laboratory reagents.
• Biochemical, biological, microbiological, and molecular biology analyses on incoming materials, raw materials, process samples, finished products, and stability study samples.
• Microbiological monitoring in production areas.
• Transfer, development, definition, and validation of analytical methods.
• Implementation of new analytical techniques and method development in collaboration with R&D.
• Drafting of internal analytical methods and procedures.
• Preparation of validation and stability protocols and reports.
• Documentation management related to analytical activities.
• Use of software in accordance with data integrity principles.
• Management of analytical standards, reagents, and consumables.
• Periodic maintenance of laboratory equipment, cleaning of classified areas, and instruments.

The offer is open to both genders and inclusive of protected categories, respecting equal treatment and privacy laws.

About Anemocyte

Anemocyte is an Italian biotech manufacturing organization specializing in development, production, and analytical services in:

• pDNA – Production of plasmids (R&D, High Quality, GMP) for viral vectors and mRNA.
• mRNA – Production of mRNA (R&D) for vaccines and therapeutic applications.

Our experience includes:

• Over 20 years in developing and producing cell and gene therapies and nucleic acids (from R&D to GMP).
• Supporting numerous projects with customized solutions based on client needs and project complexity. More at www.anemocyte.com