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.
• 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.
o GE Life Sciences column hardware and Unicorn based HPLC systems.
• 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
Preferred Additional Skills (i.e., Computer):
• Excellent communications skills and good attention to detail.
• Ability to work in fast paced, dynamic, 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.