Manufacturing Associate I/II

KBI Biopharma; Durham (NC); On-site; USD 10,000 - 60,000; Full time

Job summary

An established industry player is seeking a Manufacturing Associate I/II to execute upstream or downstream production activities in a GMP environment. This role requires meticulous adherence to quality standards and guidelines while working with various operations, including media preparation, bioreactor handling, and drug filling. Ideal candidates will possess a relevant degree or equivalent experience, showcasing strong communication skills and the ability to thrive in a fast-paced environment. Join a dynamic team committed to excellence and innovation in biopharmaceutical manufacturing.

Qualifications

• Bachelor’s degree or high school diploma with GMP experience required.
• Basic knowledge of cell culture and purification preferred.

Responsibilities

• Manufacture cell culture products in compliance with quality standards.
• Perform operations in a cleanroom with aseptic controls.
• Document tasks accurately adhering to GDP.

Skills

Cell Culture

Aseptic Techniques

Chromatography

Analytical Tools

Problem Solving

Communication Skills

Basic Math

Multitasking

Education

Bachelor’s in a related scientific/engineering field

High school diploma with GMP experience

Tools

MS Office

ERP Software

EDMS

Production Equipment Software

Job description

Join to apply for the Manufacturing Associate I/II role at KBI Biopharma

The Manufacturing Associate I/II is responsible for executing Upstream or Downstream production activities for cell culture programs within a GMP environment.

The role requires following instructions from SRs, EPRs, BRs, SOPs, and forms, ensuring all work complies with GMP, GDP, and GLP standards, including 'Right the First Time' (RFT).

The candidate must demonstrate ownership of production processes and environment, with exposure to various operations such as media/buffer prep, shake flask, bioreactor, cell harvest, aseptic techniques, chromatography, ultrafiltration, and drug filling, along with analytical tools and auxiliary equipment.

Job Responsibilities:

1. Manufacture cell culture products following batch records in compliance with quality standards and regulations.
2. Perform operations in a cleanroom, applying aseptic controls, gowning, and cleaning procedures.
3. Document tasks accurately in SRs, EPRs, and BRs, adhering to GDP.
4. Ensure proper issuance and accounting of items during record execution.
5. Understand and apply current cGMP guidelines to tasks.
6. Participate in and maintain room 5S standards.
7. Perform maintenance on equipment as per SOPs.

Minimum Education/Experience:

• Associate I: Bachelor’s in a related scientific/engineering field with 0-2 years’ GMP experience, or high school diploma with 3-5 years’ GMP experience.
• Associate II: Bachelor’s with 2-5 years’ GMP experience, or high school diploma with 4-6 years’ GMP experience.

Additional Requirements:

• Basic knowledge of cell culture, fermentation, or purification is preferred.
• Experience with single-use platform technology is preferred.
• Excellent communication skills required.
• Must be organized, motivated, and able to multitask in a fast-paced environment.
• Fluent in English, with the ability to interpret documents and communicate effectively.
• Capable of problem-solving and interpreting instructions in various formats.
• Proficient in basic math and data interpretation.
• Physical ability to stand, sit, lift, push, pull, and use ladders as needed.
• Proficiency in MS Office, ERP, EDMS, and production equipment software.
• Experience with lab and production equipment listed in the original description.

Ranges:

• Associate I: $26.44/hr - $36.49/hr
• Associate II: $30.29/hr - $41.78/hr

KBI Biopharma is committed to safety and health standards, including COVID-19 vaccination policies. We encourage diverse applicants and provide equal employment opportunities.