KBI : US - Manufacturing Technical Training Specialist I / II

Manufacturing Technical Training Specialist

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.

Position Summary :

The Manufacturing Technical Training Specialist is a member of the manufacturing group for a Contract Development & Manufacturing Organization (CDMO) performing research, process development and GMP manufacture of mammalian cell culture bulk drug substance. The core responsibility of the Manufacturing Technical Training Specialist is to manage all aspects of the technical training program for the GMP manufacturing team at the Durham manufacturing facility. The individual will work with manufacturing management to develop and manage the hands-on training curriculums, technical training plans, and training documentation for the manufacturing staff. Additionally, the individual will be responsible for developing OJTs, ILCs and technical training content, creating and revising task training documentation, and performing on the job training for manufacturing equipment in upstream, downstream, and support services. The Technical Training Specialist is also responsible for developing and providing training presentations with subject matter experts on relevant topics, working with Manufacturing Management to develop curricula, providing measures to ensure complete understanding / proficiency, and providing CAPA support stemming from investigations. Other training related materials and responsibilities will be assigned per the discretion of the head of manufacturing.

Responsibilities :

Technical Training Specialist I :

• Lead or assist in the development of classroom (virtual and in-person) training, computer-based training, and On the Job (OJT) training programs based on user requirements
• Facilitate classroom training including new employee orientation, annual cGMP training, and programs for supported quality systems
• Assist with the administration of the Learning Management System (LMS) & perform data entry in LMS
• Provide support for training inquiries and projects
• Facilitate projects and training initiatives that drive quality, compliance, and operational effectiveness for the organization
• Other duties as assigned

Technical Training Specialist II :

Requirements :

Technical Training Specialist I : B.A. / B.S. in a Life Sciences discipline and 3+ years relevant experience or equivalent experience with a high school degree.

Technical Training Specialist II : B.A. / B.S. in a Life Sciences discipline and 5+ years or equivalent experience with a high school degree.

Must possess knowledge or experience in Upstream process including bioreactor or Downstream process including AKTA, Chromatography, and column packing.

Experience in SAP or related inventory system

Experience within the biologic, pharmaceutical or medical device industry with responsibilities for performing and / or developing or delivering training to colleagues

Proficiency with electronic systems, including Power Point, Microsoft WORDS and Excel, Compliance Wire, EtQ, and other enterprise systems

Must be effective in presentation skills

Excellent written and verbal communication skills

Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine Manufacturing operations

Possesses the knowledge of adult learning theory, training delivery and how to meet the needs of the learner is ideal

The individual may be required to perform training and interact with staff who work nights and may be required to work off normal business hours to support manufacturing staff. The expected shift will be from Monday-Friday 0800 AM to 0500 PM with one day of the week is work from home. Schedule may shift to accommodate evening classes.

Salary Range :

Technical Training Specialist I : $74,000 - $102,300

Technical Training Specialist II- $84,000 115,500

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.

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.