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Medvacon Life Sciences

Supervisor, Manufacturing Job at Medvacon Life Sciences in Baltimore

Medvacon Life Sciences, Baltimore, MD, US, 21218


Job Description

Job Description
This is a temporary contracted position.

Important Notice: Protecting Your Information
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to jobs@medvacon.com.

This position requires attention to detail and must be performed in accordance with standard operating procedures and all applicable regulatory and GMP requirements.Key Responsibilities:
  • Manage the creation, implementation and compliance for all documentation, procedures and policies
  • Operate within the requirements of a validated manufacturing systems, plan, assign and oversee daily operational activities associated with assigned areas of responsibility.
  • Maintain operating and storage areas that are compliant, efficient, effective and safe.
  • Identify strategic and operational issues to prevent deviations and maintain a compliant environment. Lead and manage the development of corrective and preventative actions, deviation responses and investigations.
  • Manage implementation and maintenance of appropriate training curricula
  • Create an environment of teamwork, open communication, and a sense of urgency. Foster a culture of safety and compliance that embraces safety in the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements.
  • Efficiently coordinate, communicate, and provide Operations project information and activities status to Planning, Manufacturing, Quality Assurance / Operations, Global Supply and other associated functions in a timely manner in accordance to schedules and defined implementation timelines
  • Oversee operators on daily basis as they:
    • Perform unit operations and support operations described in standard operating procedures and batch records in a safe and GMP compliant manner.
    • Complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
    • Maintain training assignments to ensure the necessary technical skills and knowledge.
    • Assist in the setup of manufacturing areas and equipment/fixtures and perform facility and equipment commissioning, qualification and validation activities.
    • Writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
  • This position will require shift work, including holidays and weekends.
  • This position may require you to work in a clean room environment, with exposure to human blood components and in close proximity to strong magnets.
 Required Background and Experience:
  • Bachelors in relevant science or engineering discipline, or equivalent in work experience.
  • 5+ years of experience in cGMP biologics cell culture manufacturing
  • Experience in the following is highly preferred:
    • Cell therapy manufacturing
    • Aseptic processing in ISO 5 biosafety cabinets and universal precautions for handling human derived materials in BSL-2 containment areas.
  • Cell expansion using incubators and single use bioreactors, Cell washing processes, Cell separation techniques and cryopreservation processes and equipment.
  • Have previous leadership/supervisory experience
  • Can prioritize multiple assignments and changing priorities

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