Position Summary

The Manufacturing Compliance Intern will apply scientific principles to support batch report generation, manufacturing record review, and manufacturing improvement projects including CAPAs and manufacturing document revisions. This role will provide exposure to biopharmaceutical manufacturing operations in a cGMP manufacturing facility which also includes pre-quality review and material usage reconciliation.

Position Description

• Supporting the preparation of batch trends and reports as required. This will include reports for the process monitoring of upstream cell culture, harvest, and downstream purification operations. Compiling and analyzing process data to identify process excursions and entering appropriate comments in the electronic batch records.
• This includes supporting deviation investigations and CAPA implementations as needed.
• Supporting Operational Excellence initiatives in support of cGMP production runs. This includes review of ongoing operations, determining opportunities for improvement, and implementing solutions. This may also include supporting 5S implementation activities.
• The candidate should be able to apply engineering principles in order to problem-solve and drive assigned projects to successful completion within defined timelines. The ability to manage multiple projects and resources is required.
• Supporting Operational Excellence initiatives in support of cGMP production runs. This includes review of executed batch operations and determining opportunities for improvement.
• Training on KBI Standard Operating Procedures
• Collect, organize, and analyze process data from engineering and manufacturing runs for presentation at project meetings if needed.

Position Requirements

• High school degree or equivalent, and is currently enrolled in a Bachelor's degree program in engineering or life sciences program, or equivalent.
• Ability to read and interpret English documents such as safety rules, SOPs, and batch and production records

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.