Manufacturing Technician (Bioprocessing)

Kelly Science is excited to be hiring a Bioprocessing Manufacturing Technician (Direct Hire) for a leading pharmaceutical manufacturing company in El Segundo, CA!

The Manufacturing Technician will be responsible for supporting Cell Culture manufacturing.

All functions and roles of the Upstream manufacturing process are required to be performed with adherence to cGMP to ensure successful, quality operations.

The candidate will also participate in cross-functional projects with Product Development (PD) and Process Engineering (PE) to develop, scale up and transfer new products.

DUTIES AND RESPONSBILITIES
Performs manufacturing activities according to cGMP guidelines, including batch record execution, product and equipment changeover, manufacturing equipment troubleshooting, issue resolution.

Execute process operations in accordance to dynamic production timeline.

Ensures safety and cGMP compliance in manufacturing area at all times Communicate transparently with management.

Cell culture expansions and aseptic techniques Operate 20L and 50L Rocker Modules, including familiarity with Unicorn control system Operate and maintain NOVA Analyzers TFF Harvest operations Develop and author necessary supporting cGMP documentation that supports all Cell Culture manufacturing processes.

Successfully maintain aseptic gowning qualification status and participate in annual media fills.

Effectively engage cross-functionally with other departments in order to stream-line all operations supporting cGMP manufacturing.

Cross-train on and assist with Downstream operations as required.

Contribute to and develop process improvement initiatives with all Cell Culture manufacturing equipment and operations.

Assist or execute ordering of material and ensure that equipment and materials are available for production runs.

Responsible for assisting the On-The-Job (OJT) training of new or junior Cell Culture manufacturing operators.

Maintain and sustain all organizational training profile requirements.

REQUIRED COMPETENCIES (KNOWLEDGE, SKILLS AND EXPERIENCE)
BA/BS in a Life Science discipline AND 2-5 years of cGMP Biopharmaceutical manufacturing industry experience in multi-product facilities OR MS with 1-3 years of Industry Experience Strong interpersonal skills with demonstrated ability to positively affect outcomes within the Team and within the extended Team of external stake holders Ability to multitask projects simultaneously and prioritize projects.

Fluency with MS Office (Word/Excel/PowerPoint/Project/Visio/OneNote) Excellent oral and written communication skills.

Must have ability to perform work while wearing the appropriate gowning material for cleanroom environments and work under aseptic conditions in a class 100 environment (BSC).

Ability to work weekends occasionally to support the dynamic production schedule and relevant timelines.

Ability to occasionally work extended shift hours to support the dynamic production schedule and relevant timelines.

Must have the ability to manage up to fifty (50) pounds at a time and stand for extended periods of time while wearing appropriate clean room gowning material and appropriate personal protective equipment is required.