<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>The Manufacturing Specialist supports the rapidly expanding GMP Contract Manufacturing Operations team. The Specialist will need to produce high-quality documentation that contributes to the overall success of our operations. Additionally, is responsible for the overall timely revisions needed to improve process/equipment procedures, forms and other misc. cGDP Manufacturing documents for Upstream, Downstream and/or Support.</p> <p>The position requires working with minimal supervision to manage assigned workloads from initiation to completion. The Specialist should have experience in Biotechnology Manufacturing and quality system writing.</p> <p>Responsibilities:</p> <ul> <li>GDP Document Author for new and updated documents to support GMP operations for both new and existing processes/products. </li><li>The Specialist will provide CAPA/Change Control Implementer roles/responsibilities to support on time CAPA/Change Control closures. Including but not limited to GMP Document revisions, change support and implementation of action items required. </li><li>Properly assess the manufacturing environment and independently conceives and documents appropriate corrective/preventative actions designed to mitigate Quality deficiencies identified in the investigative processes or process improvement. </li><li>Own/Drive timely and accurate corrections and Batch Record Review for the Manufacturing team. </li><li>Produce high-quality documentation that meets applicable standards and is appropriate for its intended audience. </li><li>Support the Quality Assurance team to ensure alignment between areas, communications, training and changes are efficiently completed. </li><li>Execute Periodic Reviews as required to ensure all documents meet all GDP requirements per applicable procedures/guidelines. </li><li>Demonstrates strong technical skills. Provides technical assistance to area supervisors or managers to solve complex problems. Exercises judgment in developing practices, techniques and evaluation criteria for obtaining results. </li><li>Work off-shift hours as necessary or assigned. </li></ul> <p>Requirements:</p> <p>Knowledge, Skills, Abilities</p> <ul> <li>Specialist I: High School Diploma with 5+ years' related industry experience (fermentation, cell culture, purification); Bachelor's Degree in a related scientific or engineering discipline preferred with 2+ years' related industry experience; Master's degree in a related scientific or engineering discipline preferred with 0+ year's related industry experience. </li><li>Specialist II: High School Diploma with 8+ years' related industry experience (fermentation, cell culture, purification); Bachelor's Degree in a related scientific or engineering discipline preferred with 4+ years' related industry experience; Master's degree in a related scientific or engineering discipline preferred with 2+ year's related industry experience. </li></ul> <p>Language Ability</p> <ul> <li>Ability to read and interpret English documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records. Ability to write routine reports and correspondence. Ability to speak effectively before internal groups or employees of organization. Good deductive and inductive critical thinking skills required. </li></ul> <p>Reasoning Ability</p> <ul> <li>Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Strong time management skills and an ability to multitask in a fast-paced environment. Ability to deliver high quality documentation paying attention to detail. </li><li>Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures. </li></ul> <p>Math Ability</p> <ul> <li>Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. </li></ul> <p>Physical Demands</p> <ul> <li>Able to demonstrate clean room gowning and enter a cGMP facility. This activity requires bending, moving and executing physical tasks while wearing clean room gowning, hair net, beard cover, gloves with all applicable makeup, piercings etc, removed prior to entry into the GMP facility. </li></ul> <p>Computer Skills</p> <ul> <li>Word, Excel, E-mail, Spreadsheets, ETQ </li></ul> <p>Equipment Use</p> <ul> <li>Computer, telephone, copy and inventory management handheld devices. </li></ul> <p>Salary Range:</p> <p>$63,000 - $102,300 commensurate with experience</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, 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>