Assignment Duration: 6 months with the possibility of Full time based on performance and business needs.
Responsible for cGMP manufacturing operations at the Brammer Lexington site Downstream Operations.
• Executing aseptic operations within Biosafety cabinet and cleanroom environment.
• Preparation of buffers to support downstream purification activities.
• Performing critical downstream activities through Chromatography, TFF, Viral Filtration, and Final Formulation.
• Documentation of all activities in Batch Records, Logbooks, Forms, Etc.
• Follows verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
• Identifies, escalates and documents events and subtle variances that deviate from normal operation; participate as needed in investigations.
• Monitor processes using automated production systems and controls with limited supervision.
• Equipment preparation, sanitation and disinfection.
• Demonstrates ability to troubleshoot basic mechanical operations.
• Conducts training for less experienced personnel.
• Work in accordance with site and company EHS programs.
• Work in accordance with regulations, detailed protocols, Batch Record's, SOP's and Work Instructions.
• Fulfills role of lead trainer on numerous operations and is an area SME.
• Fulfills the role of Team Lead in the absence of the team supervisor. Responsible for assignment of duties to all team members, ensuring execution of duties, communicating at daily scheduling meetings, and providing technical support as needed.
• The incumbent will onboard and support project activities Monday through Friday, 8:00 AM to 5:00 PM. The position may transition to a 12-hour day time rotation as the site becomes operational.
• May require overtime to work evenings, weekends or holidays, as required to meet project timelines.
Experience and Skills Expectations:
• Effectively utilizes Microsoft office applications.
• Must be able to work in a fast-paced environment.
• A strong attention to detail through a 12-hour shift.
• Solid understanding of aseptic principles.
• Work towards solutions to given problems and operate under cGMP requirements.
• Work cross-functionally with support groups such as Facilities, Engineering, Contamination Control, MST, Quality Control and Quality Assurance.
• Qualify to work in aseptic environments to complete required production activities.
• Maintain facility and room inspection readiness.
• Ability to lift at least 50lbs.
• Ability to aseptically gown and/or sterile gown as needed.
• Bachelor's degree with 4-6 years of industry related experience on=the-floor leadership or subject matter expertise in cGMP manufacturing.
• High School diploma and 5-7 years' industry related experience of on-the-floor leadership or subject matter expertise in assigned area's core operations.
•Independently motivated and can work within a cross-functional team Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.