KBI Biopharma

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.

This role contains the following responsibilities covering 2nd shift hours (2:00 pm through 10:30 pm), Monday through Friday:

Position Summary:

In-Process Support Associate III (2nd Shift) will be trained to execute analytical test methods and their corresponding analytical techniques. The core function is composed of completing QC testing for in-process, characterization, release, or stability samples. Additionally, In-Process Support Associate III will complete testing, data analysis, and/or data integrity review of STAT samples in support of manufacturing operations during 2nd shift.

Responsibilities include:

• In-process, characterization, stability, and/or release testing as assigned. Capabilities include (but not limited to) HPLC, ELISA, qPCR, SoloVPE, other spectrophotometric techniques, capillary electrophoretic techniques, and compendial testing per USP with near-zero error and minimal guidance or direction
• Execution of method transfer, method qualification, and/or method validation testing performed under protocol
• Solution preparation
• Organizes and processes samples according to GxP standards
• Independent analysis and collation of data to draw conclusions
• Enter data into control charts and LIMS, if applicable
• Supports lab investigation and deviation reports
• Supports implementation of Corrective and Preventive Actions
• Revises SOPs and technical documents
• Supports team to troubleshoot testing or project challenges with comfort in presenting and communicating data
• Tracks department metrics upon request; actively engages in improvement of department metrics
• Partakes in continuous improvement projects or leading simple improvement projects
• Ensures state of safety and regulatory audit readiness at all times
• Maintains work to current Good Manufacturing Practices (cGMP)
• Ensures Trainer qualification status to expand team matrix
• Laboratory support – ensures areas are neat, clean, organized, and equipment is functioning
• Participates in data review activities
• Duties may include support in STAT testing coordination
• It is the expectation that this position is required to be onsite full time with a minimum of 75% of time in the laboratory/facility

Minimum Requirements:

Knowledge, Skills, Abilities:

• In-Process Support Associate III requires Bachelor’ degree as described and 3+ years’ relevant experience or Master’s Degree with 2+ years experience.
• Excellent verbal and written communication skills.
• Experience working in a cGMP environment.

Pay Range: $30.29/hr - $41.78/hr

Pay range provided per current averages and expectations. The pay rate 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 upon hire 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 is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

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.