Immediate opportunity for four (20) MCS Manufacturing Associates. The Associate of Manufacturing will work in a dynamic production environment at the Thousand Oaks Drug Substance plant at one of the world's leading biotechnnology companies located in Thousand Oaks, CA. As a Manufacturing Associate, you will be supporting development, clinical, and commercial activities. Under general supervision, employee will perform operations in the Manufacturing area. Operations will be performed according to Standard Operating Procedures (SOPs).
Shifts: Available to work various shifts (Days, Swings, Graves, Weekends, Holidays, 5x8hrs, 4x10hrs, 3 or 4x12hrs) as dictated by the production schedule
- Days, Swings, Graves, Weekends, Holidays, 5x8hrs, 4x10hrs, 3 or 4x12hrs, as dictated by the production schedule
- 4 x 10 Sun – Wed or Wed – Sat, Days or Swings
- 4 x 12, 3 x 12 Sun-Tues/Wed or
- Wed/Thurs- Sat, Days or Graves
- Must be flexible to work multiple shifts; cannot guarantee a shift before hire.
Position type: 6 months (through April 2025); extension likely up to 18 mos.
Position Overview: The Associate of Manufacturing will work in a dynamic production environment at the Company Thousand Oaks Drug Substance plant supporting development, clinical, and commercial activities. Under general supervision, employee will perform operations in the Manufacturing area. Operations will be performed according to Standard Operating Procedures (SOPs).
Essential Duties and Responsibilities:
- Hands-on operations: set-up, cleaning, and sanitization of various manufacturing equipment
- Preparing buffers/media per defined manufacturing procedures (MPs) and standard operating procedures (SOPs)
- Following GMP documents (SOPs, MPs) with strict adherence to safety and compliance
- Performing and monitoring critical processes with the ability to perform basic troubleshooting
- Performing in-process sampling of equipment and operating analytical equipment
- Performing washroom activities: clean small and large scale equipment used in production activities
- Maintaining an organized and clean workspace
- Working in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work
- Initiating quality reports
- Drafting and revising documents (SOPs, MPs)
- Identifying, recommending, and implementing improvements related to routine functions
- Assisting in the review of documentation for assigned functions (equipment logs, batch records)
- Performing activities that include periods of rigorous, repetitive work
- Working around high-pressure systems and occasionally work around heavy equipment
- Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs, 3 or 4x12hrs) as dictated by the production schedule
- Able to work in teams to complete operational tasks Able to take direction well, follow documents and policies at all times Able to take initiative
- Creates positive work environment through interactions with team members
- Able to regularly lift up to 35lbs, push and pull objects that require up to 50lbs of force, and work on your feet for long durations
- Able to perform the list of physical movements that may be necessary to perform daily functions on the production floor: bending, reaching above the head, climbing, kneeling, squatting, stooping, walking upstairs, and standing on portable stairs or ladders up to 6 feet off of the ground.
Qualifications:
- Bachelor's degree (BS) OR Associate's degree (AS) and 4 years of experience OR High school diploma / GED and 6 years of experience.
- Mechanical ability/expertise
- Basic statistical mathematical skills
- Ability to interpret and apply GMP knowledge
- Understanding of analytical methods for manufacturing area
- Demonstrated technical writing capability
- Able to demonstrate project management skills and presentation skills
- Ability to understand, apply and evaluate basic chemistry, biology and physical principles
- Basic troubleshooting skills on production equipment
- Experience with Delta V is a plus
- Experience with lab equipment/testing