Position Summary: The Manufacturing Associate works as part of the manufacturing team to deliver high quality cell therapy materials during process transfers, routine production, and technology improvements. This position contributes to the successful delivery of released product in support of clinical trials and commercial production.

Reports to: Manufacturing Supervisor

Function: Technical Operations (Manufacturing)

Location: Thousand Oaks, CA

Primary Responsibilities

• Performs Aseptic operations in a Grade A environment
• Support production in an aseptic environment.
• Executes on paper/ MES production batch records according to SOPs/ WINs.
• Generates work orders.
• Assist in all areas of cell culture and all related duties as required including (stocking, tracking inventory, material movement, maintaining metrics, filling out log sheets, and other special projects).
• Assists in manufacturing batch record review.
• Routine maintenance and cleaning of rooms and equipment.
• Identifies and implements continuous improvements.
• Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
• Adhere to all safety protocols and procedures.
• Generation of deviation.
• Document revision and review.

Position Requirements

• cGMP knowledge
• Basic knowledge of aseptic processing
• Basic knowledge of cell culture (preferred)
• Ability to follow verbal and written instructions
• Problem Solving skills
• Detail oriented
• Team player
• Strong communication skills
• Strong demonstrated aseptic techniques

Education & Experience:

• Bachelor of Science (B.Sc.) with 0-3 years of experience; or
• Associate degree with 2 years of experience; or
• High school diploma with 3 years of experience

Physical Requirements:

• Work is generally performed in a GMP manufacturing facility.
• Subject to extended periods of standing (8 hours).
• The position requires a combination of standing in the manufacturing environment. and walking around the facility.
• Will required weekend and some holiday work.
• Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body.

Travel:

• Possible 10%.