cGMP Cleaner/Lab Tech

Lancesoft; Frederick (MD); On-site; USD 28,000 - 41,000; Full time

Job summary

Lancesoft is seeking a cGMP Cleaner for 3rd shift operations in Frederick, MD, supporting a state-of-the-art cell therapy facility. The role involves 5x8 hour nights (10:30 pm–7:00 am) with one weekend day weekly and training during the first three weeks.

The Lab Tech II will perform cGMP cleaning in ISO Class rooms, manage sterile/non-sterile garment stocking, and ensure accurate documentation and safety compliance in a fast-paced manufacturing environment.

Qualifications

• AA Degree or High School Degree with 1+ years of operations and/or pharmaceutical/biotechnology and/or manufacturing experience.
• Physically capable to don and wear cleanroom gowns and PPE.
• Ability to lift up to 40 pounds and stand for 80% of a shift.

Responsibilities

• Performs sanitary cleaning activities as defined by SOPs and directed by Manager/Supervisor.
• Performs sterile and non-sterile stocking, staging and shifting of garments for multiple gowning rooms (FIFO).
• Maintains accurate records and completes training per SOPs.
• Maintains inventory of cleaning supplies to prevent depletion.
• Reviews and signs off documentation and assists other departments as needed.
• Works safely in compliance with company, state, and federal rules.

Education

AA Degree

High School Degree with 1+ years of operations/pharma/manufacturing experience

Job description

Job Title: cGMP Cleaner

Hours: 5x8 hours days 10: 30pm- 7: 00am (mandatory 1 weekend day a week) Training hours: 1st three weeks Monday- Friday 7: 30am-4: 00pm Location: 100% Onsite Frederick, MD

Description

GMP cleaning team Job Title cGMP Cleaner It s a cell therapy company that is focused on providing patients with highly effective, life-saving therapies. We have two commercial products, Yescarta and Tecartus, along with a robust pipeline of various autologous and allogeneic clinical programs. We are seeking a highly motivated individual to join our Manufacturing organization as an cGMP Cleaner and support the startup of brand new, state of the art, commercial Cell Therapy facility in Frederick, Maryland. The cGMP Cleaner, internally known as a Lab Tech II, will provide 3rd shift cGMP cleaning requirements and sterile and non-sterile garment stocking for our ISO Class rooms and Controlled Non-Classified Lab Areas.

Responsibilities

• Performs sanitary cleaning activities as defined by established operating procedures and as directed by Manager/Supervisor
• Performs sterile and non-sterile stocking, staging and shifting (FIFO) of usable garments for multiple gowning rooms
• Maintains accurate and complete records
• Attends and completes all training required by Company SOPs, procedures and policies
• Maintains accurate and complete inventory of cleaning supplies ensuring supplies are never depleted
• Reviews and provides signatory signoff of documentation
• Provides accurate and complete assistance to other Departments as needed
• Works in a safe and effective manner in accordance with all company, state and federal rules and regulations
• Perform any other tasks/duties as assigned by management
• Embrace the QUALITY culture

Basic Requirements

AA Degree OR High School Degree with 1+ years of operations and/or pharmaceutical / biotechnology and/or manufacturing experience

Physical Environment and Physical Requirements

Physically capable to don and wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves (PPE are essential for the health and safety of employees) Ability to wear a respirator during use of certain cleaning chemicals Perform operations within an ISO Class clean rooms Employee must be able to occasionally lift and/or move up to 40 pounds Must be able to squat, bend, kneel, and or reach for 80% of a shift Must be able to stand, walk, and/or move about for 80% of a shift

Preferred Qualifications

Clean Room sanitization experience or cGMP operational experience a plus

Task breakdown (by %)

75% cleaning 15% documentation 10% other duties as assigned