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 performing critical support functions within a cleanroom environment, including cleaning and sanitization, preparation of buffers and media, and assembling equipment kits to support manufacturing operations. This role requires strict adherence to cGMP and standard operating procedures.
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Responsibilities- Perform daily, weekly, and monthly cleanings of the cleanroom and surrounding controlled areas, including floors, walls, ceilings and equipment.
- Document and verify completion of all cleaning and sanitization tasks.
- Manage a flexible work schedule where shift work may be required.
- Obtain and stock supplies as directed.
- Conduct activities in support of production schedules as directed by senior staff.
- Perform a variety of complex tasks in accordance with cGMP, cGDP, SOPs and Batch Records.
- Support floor operations for multiple projects simultaneously.
- Accurately prepare buffers and media according to SOPs and batch records.
- Monitor and maintain appropriate inventory levels of raw materials required for buffer and media prep.
- Track and label each equipment kit, ensuring that each kit meets quality and regulatory requirements.
- Safely handle and transport raw materials, finished product and equipment in and out of the cleanroom, adhering to aseptic technique.
- Accurately document all cleaning, preparation, and kit assembly activities in batch records and logbooks, ensuring compliance with cGMP and regulatory standards.
- Operate to the highest ethical and moral standards.
- Adhere to quality standards set by regulations and Abzena policies, procedures, and mission.
- Follow detailed instructions and to maintain accurate records.
- Communicate effectively the status of floor operations to leads.
- Use production equipment in accordance with established practices.
Qualifications- 0-4 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.
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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.