Senior Manufacturing Associate I/II (Days)

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.

Position Schedule:

This position is for a Senior Manufacturing Associate I/II working 6:00 AM - 6:30 PM on a 2 - 2 - 3 Day shift schedule.

Position Summary:

The Senior Manufacturing Associate I/II performs upstream and/or downstream biopharmaceutical manufacturing processes, ensuring all work follows approved procedures, GMP/GLP requirements, and Right First Time (RFT) principles. This role requires hands-on experience with upstream, downstream, and manufacturing support equipment, as well as general bioprocessing tools.

Using their technical expertise, the Senior Manufacturing Associate supports daily operations by training colleagues, troubleshooting issues, and driving continuous process improvements. The role also includes reviewing production schedules, manufacturing records, forms and ERP orders to ensure compliance and on-time execution, while promptly communicating questions, concerns, or deviations through established quality and management processes.

Responsibilities:

• Manufacture bulk intermediates and drug substances per manufacturing batch records and in compliance with quality standards, company policies and current regulations.
• Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures.
• Document each task involving manufacturing records and logbooks following GDP at the time of execution.
• Utilize and perform maintenance on equipment per applicable SOP.
• Ensure all materials are issued and accounted for during the execution of a record (i.e. SPR, BPR and Forms).
• Demonstrate, apply, and ensure understanding of cGMP and how it applies to specific tasks and responsibilities.
• Participate and be accountable for workplace organization (5S).
• Provide direction/guidance to Manufacturing Associates. Help supervisor to distribute the workload and ensure others understand the requirements of their tasks.

Requirements: 

• Senior Manufacturing Associate I: Bachelor’s degree in a related scientific or engineering discipline with 4-6 years’ experience in related GMP manufacturing operations; or high school degree with 7-10 years’ experience in related GMP manufacturing operations. 
• Senior Manufacturing Associate II: Bachelor’s degree in a related scientific or engineering discipline with 5+ years’ experience in related GMP manufacturing operations; or high school degree with 10+ years’ experience in related GMP manufacturing operations.

Salary Range: 

• Senior Manufacturing Associate I:  $35.58 - $49.18
• Senior Manufacturing Associate II:  $40.38 - $55.53

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs.   

About KBI: 

KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com. 

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prio