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Senior Aseptic Manufacturing Specialist

2 mesi fa


Modena, Emilia-Romagna, Italia Evotec Modena Srl A tempo pieno

Evotec Modena Srl is at the forefront of the discovery and development of innovative small molecule therapies, with a strong presence in Europe and the United States. The organization possesses significant expertise in drug discovery and development, providing a robust platform to propel groundbreaking compounds into clinical trials. As part of its expansion, Evotec is committed to delivering advanced therapeutics to patients through iPSC-based treatments and off-the-shelf cell therapy initiatives. By harnessing these capabilities, Evotec aims to develop high-quality therapeutics and foster scientific partnerships with pharmaceutical and biotech firms.

We are currently looking for a GMP Manufacturing Operator who specializes in aseptic manufacturing for our cell therapy production facility.

Key Responsibilities

  • Conducts Advanced Therapy Medicinal Product (ATMP) manufacturing in accordance with GMP and Standard Operating Procedures (SOPs).
  • Performs manufacturing tasks within clean room environments, adhering to current Good Manufacturing Practices (cGMP).
  • Prepares necessary equipment and raw materials for the manufacturing process.
  • Executes aseptic process simulations to ensure compliance.
  • Maintains accurate documentation and oversees equipment upkeep.
  • Immediately reports any operational issues to management.
  • Ensures adherence to safety regulations and policies.
  • Participates in training sessions and contributes to the development of SOPs.
  • Assists in quality investigations and supports clean room qualification activities.
  • Collaborates effectively with the process development team.

Required Skills & Qualifications

  • In-depth knowledge of GMP regulations.
  • Proficient in drafting SOPs and batch records.
  • Experience in Risk Analysis methodologies.
  • Ability to work effectively in aseptic manufacturing settings.
  • Strong collaborative skills and problem-solving capabilities.
  • Excellent organizational and prioritization skills.
  • Intermediate proficiency in scientific English.
  • Competence in Microsoft Office applications.

Educational Background

  • Master's Degree in Biomedical Laboratory Techniques, Biotechnology, or Biology.

Professional Experience

  • A minimum of one year of experience as a Pharma/Biotech aseptic Manufacturing Operator.
  • Experience working in clean room environments.
  • Prior experience in cell culture is essential.
  • Familiarity with iPSC technology is advantageous.
  • Exposure to technology transfer from Development to GMP is beneficial.

FR: Evotec valorise la diversité en étudiant toutes les candidatures, notamment celles des personnes en situation de handicap.

ENG: Evotec promotes diversity by considering all applications equally, including those from people with disabilities.