Production Services Associate I

Abzena•San Diego, CA

10d•Onsite

About The Position

With extensive experience in developing biologics and bioconjugates, Abzena offers a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, they find the best solution and use the right technologies to design, develop and manufacture products to ensure vital medicines are delivered to patients quickly and safely. They are dedicated to quality excellence and driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. Abzena is more than a CDMO; they are a responsible and dedicated partner that takes care of products from concept to patient. The Production Services Associate I will be responsible for supporting both downstream and upstream production in a cGMP manufacturing environment. The Production Services 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 adherence to cGMP and standard operating procedures. Example Plan Shift Schedule: - First Day (Orientation): 9-5 am (Tuesday) - Day after Orientation: 2:30-11 pm M-F Schedule is subject to change based on needs.

Requirements

0 – 2 years of experience in manufacturing production.
A high school diploma is required.
Knowledge and understanding of cGMPs.
Experience using single-use technologies and disposable systems.
Ability to compute basic arithmetic operations: addition, subtraction, multiplication, and division.

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.
Perform daily, weekly, and monthly cleanings of the cleanroom and surrounding controlled areas, including floors, walls, ceilings and equipment.
Maintain and stock supplies as directed. (i.e. gowning, and emergency kits, ect.)
Documentation/verification of task completion in accordance with cGDP, SOPs and Batch Records.
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 a team setting.
Follow detailed instructions and to maintain accurate records.
Set up 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.
Comply with Abzena's policies and procedures.
Communicate effectively in a team environment.
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.