Work Schedule
12 hr shift/days

Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

How will you make an impact?

The candidate will be responsible for the routine performance of operations in support of the manufacture of commercial and clinical biologics. These support activities consist of environmental cleaning and formulations of buffers and media per established standard operations procedures and in compliance with cGMP documentation practices.

• Preparing for and execution of manufacturing batch records, work instructions, and/or SOPs, with focus on safety and "right the first time" executions with minimal oversight.
• Weigh, Transfer, and Mix chemicals
• Documentation of all activities to meet cGMP requirements. Maintain cGMP compliance in assigned work and follow all safety procedures, to include the use of Person Protective Equipment.
• Complete preventative maintenance and work notification tasks on time. Equipment testing and routine troubleshooting of process and analytical equipment.
• Draft, review, and revise documents as needed.
• Run in-process analytical testing as required per the batch record..
• Maintain Raw Materials inventory through use of systems such as Kanban.
• Maintain up to date training records
• Participate in other required activities (perform safety inspections, participate in improvement projects, etc.)
• Participate in shift exchanges, 1-1's, meetings, attend meetings as needed to facilitate area needs based on changes, etc. (lean activities)

• Required: No previous work experience required
• Preferred: Previous work experience in manufacturing, operations, production or lab setting or related field
• Preferred: Experience in a cGMP environment

• Knowledge of cGMP practices, aseptic techniques, or chemical concepts preferred

• Strong math skills
• Detail oriented
• Focused on achieving outcomes
• MS Office

• Able to read, write, and communicate in English
• Able to understand and carry out instructions
• Reliable
• Effectively multi-task
• Adaptable to a multifaceted work environment
• Possesses the ability to work both autonomously and collaboratively in a team environment.

• Be willing to wear a full gowning suit which includes: bodysuit, gloves, hair & beard nets, face covers, and safety glasses. (These items are prohibited: makeup, jewelry, nail polish, cologne / perfume, scented lotions or hair care products, etc.)
• Able to adhere to clean room gowning requirements, including wearing Tyvek, Nitrile, and/or Latex gloves
• Ability to lift minimum of 25 lbs independently
• Ability to stand for 80% of shift