Job Summary:

The primary focus of the Manufacturing Associate role will be cellular therapeutic manufacturing during process transfers, routine production, and technology improvements. The key deliverables for this role are (1) helping to establish the site's manufacturing operations and (2) completing production assignments with a high quality and timely output.

Primary Responsibilities:

• Performing patient process unit operations and support operations described in standard operating procedures and batch records.
• Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
• Performing tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
• Completing training assignments to ensure the necessary technical skills and knowledge.
• Assisting in setting up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities.
• Writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
• Working with production planning, Sr. Manufacturing Manager, and lead associates to establish daily unit operations schedule that includes people, product, and material flow across multiple shifts.

Required Qualifications:

• Bachelors in relevant science or engineering discipline, or equivalent in work experience.
• 0-2 years of experience in cGMP biologics cell culture manufacturing, experience in cell therapy manufacturing preferred.
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Must have the ability to work assigned shift (Day, Night, Weekends and/or Holidays).
• Must be able to work in a cleanroom environment and perform aseptic processing; maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.
• Must be comfortable in a clean room environment, which is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
• Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
• Must be comfortable being exposed to human blood components.
• Must be able to be in close proximity to strong magnets.
• Must be willing to work 5:00 am - 5:30 pm or 5:00 pm - 5:30 am three to four times a week.

Preferred Qualifications:

Experience in cell therapy manufacturing
Experience in the following preferred:
Aseptic processing in ISO 5 biosafety cabinets.
Universal precautions for handling human derived materials in BSL-2 containment areas.
Cell expansion using incubators and single use bioreactors.
Cell washing processes and automated equipment.
Cell separation techniques and automated equipment.
Cryopreservation processes and equipment.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. During higher times of processing these activities may increase.

Please apply via: https://bristolmyerssquibb.wd5.myworkdayjobs.com/BMS/job/Bothell---WA---US/Biotech-Manufacturing-Associate-I_R1521143-1