Greetings, we are looking for a 2nd Shift Assistant, CGMP Biomanufacturing for one of our direct clients in Madison WI 53717.

Shift Timing: Sun – Wed, 2pm – 12am


This is an entry level position for the Downstream department focusing on mRNA/therapeutics production and is the starting point to acquire skills and training required for a cGMP Biomanufacturing environment. The position is expected to follow detailed instructions and established procedures with frequent supervision.


Performs aseptic techniques within in a clean room environment.

Executes and properly documents cGMP Biomanufacturing activities.

Stages raw materials/components for use within cGMP Biomanufacturing.

Performs general cleanroom housekeeping, including room and equipment cleaning(s), disposal of trash and recyclables, and adherence to 5S standards.

Supports Biomanufacturing staff with proper completion of Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aid (JA) as applicable.

Complete inspections of GMP facility as required.

Actively participates in team meetings and/or training sessions.

Works scheduled shift and other off-shift coverage as required.

Education: Required:

High School Diploma or equivalent.

Experience: Preferred:

Clean room, aseptic technique, and/or general lab equipment experience

cGMP, Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) knowledge.

Following standard operating procedures (SOP).

Technical Requirements:

Ability to maintain batch records and/or laboratory notebook and complete all laboratory documentation in clear and accurate language and according to SOP.

Ability to attend training and apply learning on routine operation, maintenance and theory or laboratory instrumentation, SOPs, and regulatory guidelines.

Ability to use Excel, Word, and other office systems.

Ability to add, subtract, multiply, divide and to record, balance, and check results for accuracy.

Ability to peer review data to ensure data is well organized with complete documentation.

Ability to work within ISO 6/7/8 clean room environments.

Behavioral Requirements:

Ability to see and hear, read and write clear English.

Requires adaptability, analyzing, assessing, calculating, decision making, dependability, good judgment, reading, memorizing, social skills, speaking, stress control, writing.

Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, in a professional and accurate manner.

Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time

Ability to cooperate with coworkers within an organized team environment or work alone.

Detail oriented with ability to work effectively under high pressure with multiple deadlines.

Ability to put aside personal opinions and focus on business needs, department needs or group needs.

Safety and Environmental Requirements:

Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening.

Occasional stooping, kneeling, crouching, bending, carrying, grasping.

Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds.

Must comply with EHS responsibilities for the position.

Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures must be followed to minimize exposure, including proper use of PPE (personal protective equipment) and clean room gowning.

Leena Singh

Talent Acquisition Specialist


Phone: / Ext: 7137

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