Fill & Finish Manager (m/f/d) - Latina - Aenova Group

    Aenova Group
    Aenova Group Latina

    1 giorno fa

    Descrizione

    for the site Borgo San Michele LT, Italy

    Would you like to make a valuable contribution to the health of patients? And do something really meaningful on your own responsibility? Then we look forward to hearing from you Excellence beyond manufacturing - that's what we stand for as Aenova, one of the world's leading contract manufacturers and developers for the pharmaceutical industry with 4,000 employees at 15 sites. Latina is a leading centre of excellence in sterile liquid production, with a strategic investment plan to become one of Europe's foremost hubs.

    Your Key Responsibilities

    • Support the implementation and qualification of the new department and sterile production line, with a focus on isolator technology.
    • Manage the formulation, filling, and packaging activities for injectable products in a sterile environment.
    • Draft and revise department documentation, including SOPs (Standard Operating Procedures) and operational protocols.
    • Manage process deviations and OOS (Out-of-Specification) results, investigating causes and implementing appropriate CAPA (Corrective and Preventive Actions).
    • Ensure the training and ongoing education of staff on operational procedures and new technologies.
    • Supervise and coordinate a team of production operators and technicians.
    • Plan and organize work shifts to ensure optimal coverage.
    • Ensure compliance with cGMP (Good Manufacturing Practices) regulations and internal quality standards.
    • Monitor operational and financial KPIs for the department, identifying and implementing corrective actions to optimize efficiency.
    • Collaborate with the Engineering, Quality, and Maintenance departments to resolve issues and improve processes.
    • Manage internal interactions as well as external interactions with Clients, Regulatory Bodies and Suppliers.

    Your profile

    • Bachelor's degree in engineering (preferably Chemical, Industrial, or Biomedical), Chemistry, Industrial Chemistry, CTF (Pharmaceutical Chemistry and Technology), or equivalent scientific/technical disciplines.
    • Solid experience (minimum 3-5 years) in supervisory or production management roles within the pharmaceutical or biotechnology sector.
    • Proven direct experience in managing sterile production and "fill and finish" processes for injectable biological products.
    • Direct experience with isolator technology is a preferred requirement.
    • In-depth knowledge of cGMP regulations (including FDA and EMA).
    • Excellent leadership, problem-solving, and communication skills.
    • Fluent in English and Italian, written and spoken.

    Your motivation


    Are you looking for new challenges in a highly competitive environment? And you want to tackle them creatively and on your own responsibility? Do you prefer a "get-it-done" culture and think in terms of solutions rather than problems? What are you waiting for? We would be happy to explain our corporate benefits in a personal conversation

    Apply now


    If you have any questions, I - Chiara Fanasca / Human Resources - will be happy to help you: Chiara.-

    Haupt Pharma Latina S.r.l.

    • Member of the Aenova Group
    • Strada Statale 156 dei Monti Lepini
    • 04100 Borgo San Michele LT, Italy

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