Description
Position Summary:You will be a part of the manufacturing organization and provide hands-on execution of tasks related to the cGMP manufacture of biopharmaceuticals working in bacterial fermentation, purification and/or fill-finish.Essential Functions:
- Operate in clean room environment.
- Assist or perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.)
- Ensure compliance with established internal control procedures.
- Troubleshoot equipment and manufacturing processes.
- Routine assembly/disassembly and cleaning of manufacturing equipment.
- Assist in the execution of process, equipment and cleaning validation.
- Write and revise SOP's and Batch Records.
- 3+ years experience with pharmaceutical or biotechnology manufacturing processes; or equivalent education, training, and experience.
- Hands-on experience in a cGMP environment
- Hands-on experience with fermentors at 100L scale or greater preferred
- Hands-on experience with cGMP UF/DF and chromatography equipment preferred.
- Experience with process development, transfer, and optimization a plus.
- Experience with execution of validation protocols a plus.
- Experience working with potent/toxic agents a plus
- Bachelor's degree in biological sciences, chemical engineering or related discipline
- Excellent communications skills and good attention to detail.
- Ability to work in fast paced, team environment.
- Ability to handle multiple projects at one time.
- Basic knowledge of MS Office (Word, Excel, Outlook).
- Ability to lift 25 pounds and stand for extended periods of time.
- Flexibility in job responsibilities and scheduling is encouraged to meet business needs.