Medvacon Life Sciences
Medvacon Life Sciences is hiring: Supervisor, Manufacturing in Baltimore
Medvacon Life Sciences, Baltimore, MD, United States, 21298
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 [email protected].
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:
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 [email protected].
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.
- 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