Job Description

Job Summary:
Manufacturing Training and Development Leadership

• Responsible for the maintenance and continuous improvement of the GMP Training and Development Programs for Manufacturing Personnel.
• Facilitate projects and training initiatives that drive employee engagement, development, quality, compliance and operational effectiveness for the organization.
• Develop training materials and provide guidance in development and implementation of a consistent training program for Manufacturing Personnel.
• Establish Manufacturing TRN template and minimum requirements.
• Provide support regarding manufacturing employee engagement, leadership training and communication.
• Trains and coaches managers, supervisors and others involved in employee development efforts.
• Assist in the evaluation, monitoring and follow-up of training effectiveness.
• Assess new and existing training material to ensure user and company needs are met.
• Assist course owners with implementation of training material and transfer of knowledge to trainees.
• Facilitate classroom training including process overview, train-the-trainer sessions, onboarding partnership with new hires, Facility Tour and other training(s) as needed.
• Measure course effectiveness and provide feedback to trainers and course owners. Perform needs assessments to identify training requirements and work cross-functionally to reduce deviating events attributable to knowledge and/or skill gaps in Manufacturing.
• Implement and manage training and employee engagement metrics.
• Act as process SME with detailed knowledge of the training process history, compliance, operations, changes, and deviating events.
• Oversee the creation of online learning modules and other educational materials for employees.
• Maintain up-to-date knowledge of industry and regulatory training related trends to ensure Program remains compliant with stated expectations and best practices.

Site Support

• Conduct site training for supported quality systems.
• Continuous Improvement – Training Program Development.
• Other duties as assigned

Job Responsibilities:

• Responsible for the maintenance and continuous improvement of the GMP Training and Development Programs for Manufacturing Personnel.
• Facilitate projects and training initiatives that drive employee engagement, development, quality, compliance and operational effectiveness for the organization.
• Provide support regarding manufacturing employee engagement, leadership training and communication.
• Trains and coaches' managers, supervisors and others involved in employee development efforts.
• Oversee the creation of online learning modules and other educational materials for employees.
• Maintain up-to-date knowledge of industry and regulatory training related trends to ensure Program remains compliant with stated expectations and best practices.

Minimum Requirements:

Knowledge, Skills, Abilities

• BA/BS degree in Life Sciences, Education or Psychology.
• A minimum of 7 years’ experience in the pharmaceutical or biopharmaceutical industry required.
• A minimum of 5 years of experience designing and implementing employee development programs.
• •Prior experience leading or managing a training program within a regulated environment preferred.
• Excellent organizational, planning, communication, presentation and writing skills.
• •Comfortable communicating with all levels of the organization and demonstrate the ability to clearly present information to both large and small groups of people.
• Additional experience in manufacturing or technical operations within the biotechnology industry is a plus.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• •Ability to write routine reports and correspondence.
• Ability to speak effectively before groups of customers or employees

Reasoning Ability:

• 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.

Math Ability:

• 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.

Physical Ability:

• ​• While performing the duties of this job the employee is frequently required to sit.
• The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear.
• The vision requirements include close vision and distance vision.

Computer and Equipment Skills / Use:

• The employee should have experience using and knowledge of Microsoft Office, word processing, spreadsheets, email, database software, telephone

Range: $101,000.00 / yr. - $138,500.00 / yr.

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.