The manufacturing associate in Drug Product Manufacturing will have a primary task for operation of filling line including all tasks related. This role will also support projects which influence manufacturing processes for DPM including training of others. This position will also support and assist in scheduling daily manufacturing activities for the team.
Requirements
- 6+ years of direct experience in a manufacturing environment
- Associate’s Degree + 4 years of direct experience in a cGMP manufacturing environment
- BA/BS + 2 years of direct experience in a cGMP manufacturing environment
- Equivalent Military training or experience
- Experience on specific unit operations (ex: Viral Filtration and Bulk Dispensing)
- Understanding of manufacturing run cadence and order of shift activities
- Knowledge of cGMP, safety and operational procedures
Responsibilities
- Participate and support testing activities, such as FAT, PQ etc. as well as other related activities
- Support and contribute to the preparation of the documentation package as e.g., Standard Operating Procedures, Work Instructions
- Contribute to the preparation for operational readiness related to bulk drug product manufacturing
- Supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes as well as testing and commissioning support
- Lead, execute and document manufacturing processing steps and/or manufacturing support activities as well as process monitoring and control
- Perform operations of the Drug product filling line
- Execute validation protocols according to cGMP Standard Operating Procedures (SOPs)
Other
- This role will also support projects which influence manufacturing processes for DPM including training of others.
- This position will also support and assist in scheduling daily manufacturing activities for the team.
- This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours or shift rotation.
- Travel up to 0-25% (international or domestic) may be required during the project phase
- This role requires shift work (weekend and potential for nights)
