Production Services Associate II

Abzena Inc.•San Diego, CA

6d•$50,000 - $75,000

About The Position

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Production Services Associate II is responsible for supporting both downstream and upstream production in a cGMP manufacturing environment. The Production Service team prepares buffers and media, cleaning and sanitization of the facility, assembling equipment kits to support manufacturing operations, setting up and breaking down of operational equipment in accordance with the operations schedule. This role requires strict adherence to cGMP and standard operating procedures.

Requirements

2-4 years of experience in cGMP manufacturing environment, preferably with buffer/media prep.
A high school diploma is required.
Knowledge and understanding of cGMPs.
Experience using single-use technologies and disposable systems.
Wear and maintain the required PPE to protect product integrity and ensure personal safety.
Physical ability to walk and stand for extended periods of time.
Frequently lift and or move objects up to 30 pounds.
Use arms, hands and fingers to handle, feel or reach.
Ability to climb, balance, stoop, kneel, crouch, or crawl.
Visual abilities include near and far sight, color, peripheral vision, depth and ability to focus.

Nice To Haves

Technical degree in related field preferred.

Responsibilities

Perform a variety of complex tasks in accordance with cGMP
Operate and maintain production equipment with single-use materials as it relates to buffer and media preparations, including weight and dispense.
Maintain/Perform daily, weekly, and monthly cleanings of the cleanroom and surrounding controlled areas, including floors, walls, ceilings and equipment.
Order, maintain, and stock supplies as directed (i.e. gowning, emergency kits, ect.)
Documentation/verification of task completion in accordance with cGDP, SOPs and Batch Records.
Monitor and maintain appropriate inventory levels of raw materials required for buffer and media prep.
Manage a flexible work schedule where shift work may be required.
Conduct activities in support of production schedules as directed by senior staff.
Support floor operations for multiple projects simultaneously.
Crosstrain on various tasks including Upstream/Downstream cGMP manufacturing.
Operate in both a team and individual setting.
Follow detailed instructions and maintain accurate records.
Set up and use equipment in accordance with established practices. (i.e. RTP, STR, Production Bioreactors, AKTA systems, Depth Filters and Pods, Viral Filtration, and UFDF)
Safely handle and transport raw materials, finished product and equipment in and out of the cleanroom, adhering to aseptic technique.
Operate to the highest ethical and moral standards.
Communicate effectively the status of floor operations to leads.
Participate effectively as a team player in all aspects of Abzena's business.
Adhere to quality standards set by regulations and Abzena policies, procedures, and mission.
Perform other duties as assigned.