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.

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 II:

• 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
• Manage end-to-end delivery of training to the identified learner group (i.e., scheduling, communications, tracking, and reporting training completion). Schedule in-person and virtual instructor-led training sessions; organize course logistics (invites, room bookings, etc.) for training programs
• Other duties as assigned

Technical Training Sr. Specialist:

• 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
• Manage end-to-end delivery of training to the identified learner group (i.e., scheduling, communications, tracking, and reporting training completion). Schedule in-person and virtual instructor-led training sessions; organize course logistics (invites, room bookings, etc.) for training programs
• Other duties as assigned

Requirements:

• Technical Training Specialist II: B.A./B.S. in a Life Sciences discipline and 5+ years or equivalent experience with a high school degree.
• Senior Specialist: BA/BS and 7+ years’ experience or MS and 5+ years’ experience in a QA or GMP environment or equivalent. Pharmaceutical, biopharmaceutical, or medical device industry experience required. Experience in a Training role is required.
• Must possess knowledge or experience in Upstream process including bioreactor or fermentor and/or Downstream process including AKTA, Chromatography, and column packing.
• Experience in SAP or related inventory system
• Proficiency in MODA-ES 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 2pm-11pm.

Salary Range:

• Technical Training Specialist II- $94,500 - $126,000
• Technical Training Sr Specialist- $113,400 - $151,000

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.

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.