<p>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.</p> <p>Position Summary:</p> <p>Supervise QC laboratory operation, safety, and compliance. Applies phase appropriate GMP principles to instrumentation, lab maintenance, and sample management. Manage laboratory supplies and reagent inventory. Support lab instrumentation management. Manage junior staff as assigned.</p> <p>Responsibilities:</p> <ul> <li> <p>Ensure QC laboratories are compliant and audit ready, both from a phase appropriate GMP and safety perspective.</p> </li><li> <p>Support compliance activities within QC Laboratories.</p> </li><li> <p>Review chamber monitoring system data routinely as per SOP. Act as primary contact for monitoring system for QC laboratory chambers after business hours. Assist in the investigation and resolution of any excursions or other deviations.</p> </li><li> <p>Coordinate purchase, receipt, and storage of laboratory supplies.</p> </li><li> <p>Perform daily laboratory housekeeping: lab coats, glassware wash, laboratory reagent shelf-life identification, labeling, and disposal per OSHA and HSE</p> </li><li> <p>Support the instrumentation management process with service vendor contact, instrument receipt, move, install, maintenance, and use of Blue Mountain Regulatory Asset Manager.</p> </li><li> <p>Perform laboratory instrument standardization according to SOPs using Good Documentation Practices. Review of simple instrument logbooks.</p> </li><li> <p>Facilitate and implement improved laboratory management processes.</p> </li></ul> <p>Requirements:</p> <ul> <li> <p>Bachelor's and 4+ years applicable experience. Experience in cGMP environment strongly preferred.</p> </li><li> <p>Knowledge of the operations typical to the biotechnical/pharmaceutical industry is preferred.</p> </li><li> <p>Familiarity or direct previous experience with laboratory equipment.</p> </li><li> <p>Language Ability: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.</p> </li><li> <p>Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished inwritten, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.</p> </li><li> <p>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.</p> </li><li> <p>Physical Demands: Ability to sit, stand, and walk.</p> </li><li> <p>Computer Skills: Word processing, Spreadsheets, Internet, E-mail.</p> </li></ul> <p>Salary Range: $84,000 - $115,000</p> <p>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, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.</p> <p>About KBI:</p> <p>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.</p> <p>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.</p> <p>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.</p> <p>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.</p> <p>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.</p> <p>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.</p>