Manufacturing Associate

Job Title: Manufacturing Associate I-Downstream

Duration: 06 months assignment

Location: Fremont, CA

Job Description:

Duties & Responsibilities:

• Executes routine unit operations in Downstream manufacturing as assigned related to the manufacturing of bulk drug substance in a multi-product facility.
• Performs duties under limited supervision and according to standard operating and manufacturing procedures.

Processing:

• Executes independently with adequate training non-complex fundamental operations as parts cleaning, weigh and dispense, equipment prep, kits assembly, and staging.
• Performs internal support duties including stocking consumables/materials, updating controlled SOP binders appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
• Executes with oversight of qualified staff fundamental tasks as CIP and SIP of BR's, tanks, manufacturing equipment as well as media or buffer prep and transfer into tanks and bags.
• Daily analytics and maintenance of analytical equipment.
• Cleaning and setup of equipment

Quality/Compliace

• Documents work according to cGMP and cGDP.
• Adheres to established regulations and follows cGMP established by site.
• Reports abnormalities and deviations in a timely and accurate manner.
• Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
• Maintains production areas according to predefined standards (5s).
• Keeps own training on track and trains other technicians and associates on operations.
• Contributes to Quality activities as investigations and area walk-throughs.
• Working in a highly regulated environment following all applicable Client and Client’s Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance policies.
• Required to work according to given schedules in a 24/7 shift structure and flexibility to adapt working schedule upon prior given notice.
• Strong focus on execution of routine tasks with moderate technical complexity.
• Performs highly proceduralized tasks.
• Basic interactions with Manufacturing Cell Culture, Manufacturing Purification, Manufacturing Compliance, Engineering & Technology, Supply Chain, Quality Assurance, Quality Control Basic knowledge of fundamental manufacturing concepts is preferred.
• Does not require extensive technical knowledge of manufacturing operations.
• Executing repeatable, highly proceduralized operations.
• Complex operations performed under supervision.

Skills:

• Required to work according to given schedules in a 24/7 shift structure and flexibility to adapt working schedule upon prior given notice.

Physical demands:

• Able to lift 25 lbs.
• Use of ladder will be involved.

Education:

• Associates/Bachelor's degree from an accredited institution or biotechnology vocational training preferred.
• Preferable one (1) or more years of experience in cGMP regulated industry