Senior Manufacturing Associate I/II (Night Shift)

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

Job summary

An established industry player is seeking a Senior Manufacturing Associate I/II for night shifts to oversee upstream processing of biopharmaceutical products. This role emphasizes adherence to GMP standards and involves critical tasks such as authoring SOPs, operating bioreactors, and ensuring compliance with quality standards. The ideal candidate will have extensive experience with bioprocessing equipment and a strong commitment to maintaining production quality. Join a forward-thinking company that values diversity and offers competitive benefits, including health coverage and PTO, while contributing to groundbreaking advancements in biopharmaceutical manufacturing.

Benefits

Health coverage

PTO

401K

Recognition programs

Shift differential

Qualifications

• 4-10 years of GMP experience based on education level.
• Knowledge of upstream unit operations and single-use technology preferred.

Responsibilities

• Manufacture drug substances adhering to batch records and quality standards.
• Perform equipment maintenance and manage materials efficiently.

Skills

GMP compliance

bioprocessing equipment handling

cell culture harvest

troubleshooting processes

effective communication

Education

Bachelor’s in a related field

High school diploma

Tools

bioreactors

incubators

cell counters

general lab tools

Job description

Senior Manufacturing Associate I/II (Night Shift)

Position Overview

The Senior Manufacturing Associate I/II is responsible for upstream processing of bulk intermediates and drug substances for biopharmaceutical products. They must adhere to approved procedures, GMP, GDP, and GLP standards, ensuring work is conducted 'Right First Time' (RFT). Responsibilities include authoring SOPs or MBRs, writing CAPAs, and commissioning new equipment.

The role involves upstream operations such as bioreactor handling, cell culture harvest, and equipment maintenance. The candidate should have experience with bioprocessing equipment like incubators, bioreactors, cell counters, and general lab tools. They will utilize their knowledge to troubleshoot, improve processes, and maintain ownership of production quality and environment.

Daily tasks include executing manufacturing processes, maintaining records, communicating effectively with supervisors and support teams, and ensuring compliance with GMP and SOPs. Collaboration with QA, MS&T, engineering, and other departments is essential to ensure reliable operations.

Key Responsibilities

• Manufacture drug substances in compliance with batch records and quality standards
• Operate in cleanroom environments, ensuring aseptic procedures
• Document manufacturing tasks accurately and timely
• Perform equipment maintenance as per SOPs
• Manage materials and ensure proper issuance and tracking
• Understand and apply cGMP principles
• Maintain workplace organization (5S)
• Guide and assist Manufacturing Associates and support workload distribution

Minimum Qualifications

• Senior Manufacturing Associate I: Bachelor’s in a related field + 4-6 years GMP experience, or high school diploma + 7-10 years GMP experience
• Senior Manufacturing Associate II: Bachelor’s + 5+ years GMP experience, or high school diploma + 10+ years GMP experience
• Preferred: Upstream unit operations knowledge and single-use technology experience
• Excellent communication skills

*Note: Night shift 2-2-3 schedule, eligible for shift differential*

Salary: $33.65-40.87/hour

Salary varies based on qualifications. Benefits include bonuses, health coverage, PTO, 401K, and recognition programs.

All employees must comply with COVID-19 vaccination policies and provide proof of vaccination if applicable.

KBI Biopharma is an equal opportunity employer committed to diversity. All qualified applicants are encouraged to apply.