Production Services Associate I

Abzena Inc.; San Diego (CA); On-site; USD 40,000 - 60,000; Full time

Job summary

Abzena is seeking a Production Services Associate I to support both downstream and upstream production in a cGMP manufacturing environment in San Diego, CA. You will prepare buffers, clean and sanitize the facility, assemble equipment kits, and assist with production scheduling under supervision.

The role requires adherence to cGMP, SOPs, and batch records, with an ability to work a 7:30 PM – 4:00 AM shift, including weekends. FLSA: Non-Exempt.

Qualifications

• High school diploma required.
• Knowledge and understanding of cGMPs.
• Experience with single-use technologies and disposable systems.
• Able to perform basic arithmetic operations.

Responsibilities

• Perform tasks in accordance with cGMP.
• Operate and maintain production equipment with single-use materials.
• Clean and sanitize the cleanroom and surrounding controlled areas.
• Maintain and stock supplies; document task completion per SOPs and batch records.
• Support production schedules and participate in multiple projects.
• Crosstrain on Upstream/Downstream cGMP manufacturing.
• Set up equipment per established practices and ensure aseptic handling.

Skills

cGMP knowledge

Arithmetic

Teamwork

Education

High school diploma

Tools

AKTA systems

RTP

STR

Production Bioreactors

Depth Filters

Viral Filtration

UFDF

Job description

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 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.

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.

Qualifications

• 0 - 2 years of experiencein 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.

Physical Requirements

• 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.
• Ability to work 7:30 PM - 4:00 AM shift, including weekend work as needed

$40,000 - $60,000 a year

FLSA: Non-Exempt

Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.