Senior Manufacturing Associate III (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: Bachelors 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: Bachelors 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 candidates 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 .

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 prior notice. I understand that no representative of KBI Biopharma Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma Inc. to contact references provided for employment reference checks. If any information I have provided is untrue or if I have concealed material information I understand that this will constitute cause for the denial of employment or immediate dismissal.

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 prior notice. I understand that no representative of KBI Biopharma Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma Inc. to contact references provided for employment reference checks. If any information I have provided is untrue or if I have concealed material information I understand that this will constitute cause for the denial of employment or immediate dismissal.