Position Description/Summary

Responsible for cGMP manufacturing operations at the Brammer Lexington site Support Services for Upstream and Downstream Operations.

Responsibilities include:

• Executing aseptic operations within Biosafety cabinet and cleanroom environment.
• Preparation of medias and buffers to support upstream and downstream activities.
• 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.

Work Hours:

• The incumbent will onboard and support project activities Monday through Friday, 8:00 AM to 5:00 PM. The position will 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.

Minimum Qualifications:

• 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.