Job Title: MCS Manufacturing Associate, Biopharma (JP10481) Location: Thousand Oaks, CA. Employment Type: Contract Business Unit:Pilot Plant Downstream Duration: 6 months with likely extensions Posting Date: 06/28/2022
3 Key Consulting is hiring MCS (Manufacturing and Clinical Supply) Manufacturing Associate for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
The Associate of Manufacturing will work in a dynamic production environment at the client’s Thousand Oaks Site supporting development, clinical, and launch activities. Under general supervision, employee will perform operations in the Manufacturing area. Operations will be performed according to Standard Operating Procedures (SOPs).
Responsibilities include:
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
Basic Qualifications:
Bachelor’s degree OR Associate’s degree and 4 years of Manufacturing /Operations experience OR High school diploma / GED and 6 years of Manufacturing /Operations experience
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.
Preferred Qualifications: Bachelor’s Degree in Biology and/or Life Sciences
Mechanically inclined
Top Must Have Skills: 1. Chromatography Experience - At least 1 year experience preferred (HPLC/protein) 2. Biotech Process Development or Manufacturing experience. 3. Large Scale processing, buffer prep or media prep experience. 4. Must be able to work multiple shifts at 3 month intervals (Day and swing shift)
Day to Day Responsibilities: Equipment set up, operating process equipment, buffer/media prep, equipment cleaning, sampling of in-process product pools and sample management in electronic sample management system. Red Flags: A candidate with an advanced degree may not fit well in this role (Masters degree or doctorate degree), not preferred. No BS degree in science with science background - biological/research experience
Interview process: Phone screen followed bypanel interview
We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.