Job Summary:

The Manufacturing Support Associate I position is designed as an introduction to the environment of cGMP manufacturing. This position performs all routine/nonroutine cleanings of the GMP Facilities, manages Process Waste, and continuously supports the manufacturing operations. This position requires a 12-hour shift schedule. Aseptic and Gowning Qualifications are required for this position. Must be able to document and maintain records to comply with regulatory requirements, cGMP’s, Policy Documents and SOPs.

Job Responsibilities:

• Performs and Maintains Manufacturing facilities by routine/non-routine cleanings. (Daily, Weekly and Monthly Cleanings) - Requires Aseptic and Gowning Qualifications.

• Cleans, operates and maintains the Process Waste area. Ensures cleanliness of the area and discards waste materials within the area. Cleans drums and dollies as required.

• Prepare, build and complete processing assemblies (PAR) for production.

• Completes Facilities response forms and ensures communication to inform other departments requiring EM sampling if required.

• Stock general supplies in the manufacturing production areas.

• Handling and discarding of hazardous and nonhazardous waste.

Minimum Requirements

Knowledge, Skills, Abilities

• High School Diploma or Associate Degree with 0+ years of experience.

Language Ability

• Ability to read and interpret English documents such as safety rules, standard operating procedures, and procedure manuals.
• Ability to write routine reports and correspondence.
• Ability to communicate with coworkers and supervisors.

Reasoning Ability

• Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
• Ability to deal with problems involving several concrete variables in standardized situations.

Math Ability

• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute ratio and percent

Physical Demands

• Must be able to stand, walk, wear steel toe shoes and have the ability to push, pull, squat, lift, reach and carry waste as needed, but not to exceed the Essential Physical functions of the job description.

Computer Skills

• Knowledge of and experience using Word, Excel, and email

Equipment Use

• Knowledge of and experience using a computer, a telephone, a copy machine, a max machine

Are there particular working conditions associated with this position that should be noted (i.e., working environment, hours of work, travel, work space, etc.)? Yes. Due to the use of Spor-Klenz, respirators (full faced and half faced respirators) are required for the job description, facial hair needs to be maintained short enough to ensure a good seal to properly wear the respirator.

The job requires working 12-hour shifts which may include working overnight. The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations. Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene. While performing the duties of this job the employee regularly utilizes equipment and materials which include mechanical hazards, chemical hazards, electricity hazards, and tripping and falling hazards. The noise level in the environment is moderate to high.

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 is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team

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.