Overview
The Director of Technical Learning and Knowledge Management will provide leadership in the activity based learning space within the Iovance Production Network, Philadelphia, PA. This role is responsible for maintaining and continually improving a formal training/qualification program for the operational teams including manufacturing, quality control, quality assurance, supply chain, MSAT, etc. The Director of Technical Learning and Knowledge Management is expected to lead a network of training professionals and align with Learning and Knowledge management professionals across Iovance.
As a highly effective "Right First Time" program is required for autologous cell therapy, a robust training program must be maintained to ensure timely, efficient, and effective training/qualification of individuals. This role will provide strategic guidance and support to the on-boarding program, gowning, train-the-trainer program, training files, and support the management of any training deviations and CAPAs for the training and learning team.
Essential Functions And Responsibilities
- Identify learning and knowledge management needs, devise an organizational learning strategy, learning paths and curriculum, oversee its implementation, evaluate effectiveness through competency testing, and establish a feedback loop to ensure continuous improvement. Planning and executing on the organization’s overall Technical Learning and Knowledge Management strategy for leaders as well as employees
- Introduce new Technical Learning and Knowledge Management programs on an ongoing basis to support changing strategic objective
- Anticipate (and eliminate) future skills gaps through incisive new Technical Learning and Knowledge Management programming
- Building relationships with third-party resources, vendors and partners to roll out innovative and experiential learning models
- Offer hands-on coaching and guidance to leaders as a recognized Technical Learning and Knowledge Management subject matter expert (SME)
- Collaborate with HR leaders to implement effective deployment and redeployment strategies
- Plan curriculum design and support documentation, including drafting and approval of SOPs.
- Training and development of learning network, including mentoring/coaching to motivate and mentor peers/ staff, to foster a culture of continuous improvement and operational excellence.
- Ensure efficient operations, and compliance with cGMPs and safety regulations.
- Continuously seek and support new approaches, practices and processes to improve the efficiency and efficacy of training.
- Establish key performance indicators to measure training effectiveness.
- Create processes that enable timely and actionable performance feedback of trainees.
- Develop a comprehensive understanding of current production, QC and QA processes, as this role is viewed as a subject matter expert within specific area.
- Ensure the department understands and complies with quality standards and requirements as documented.
- Organize and update company information, such as training videos, internal data, processes, and policies
- Develop initiatives to encourage employees to share their best practices and experiences
- Create guidelines for capturing information, ensure that the right information goes to the right people, and facilitating knowledge-sharing activities like webinars, working groups, and communities of practice
- Responsible for controlling how corporate knowledge is distributed, employed, and stored. This may include implementing strategies to improve the accessibility of knowledge resources and content
- Build and improve processes to capture and spread knowledge, such as setting up meetings where employees can share insights or outlining best practices
- Develop policies and processes for creating new resources, such as data visualizations and interactive dashboards
- Must adhere to Iovance Biotherapeutics’ core values, policies, procedures and business ethics.
- Complies with Safety SOPs, SDS sheets and laboratory procedures per company policy and OSHA regulations.
- Performs miscellaneous responsibilities as assigned.
Required Education, Skills And Knowledge
- Bachelors degree in Science / Engineering related field such as Pharmaceutical Technology, Chemistry, Process Engineering or equivalent.
- 12+ years of manufacturing and training experience, ideally in a Biopharmaceutical environment and/or Cell and Gene Therapy.
- Proven success leading a Learning and Knowledge Management function
- Working knowledge of Learning and Knowledge Management best practices, tools, methodologies and more
- Experience leveraging digital tools to drive measurable benefits
- Knowledge of key performance indicators (KPIs) relevant to the Learning and Knowledge Management function
- Virtual learning expertise
- Lean Practitioner and certified Green Belt, ideally Black Belt Certification
- Strong Project Management skills combined with a structured and solution-oriented work approach
- Excellent communication skills and interaction with all kinds of internal and external interfaces
Preferred Education, Skills And Knowledge
- Masters degree in Science / Engineering related field such as Pharmaceutical Technology, Chemistry, Process Engineering or equivalent. Degree(s) in Industrial Engineering.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
For the Visual Inspection Program, must be able to pass a Vision Exam that includes the following:
- Must not be color blind
- Must have 20/20 near vision in both eyes (can be corrected)
Physical Demands And Activities Required
- Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
- Must meet requirements for and be able to wear a half-face respirator.
- Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.
- Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
- Must be able to lift and carry objects weighing 45 pounds.
Mental
- Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline
Work Environment
- This position will work in both an office and a manufacturing lab setting.
- When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
- Able to work in cleanroom with biohazards, human blood components, and chemicals.
- Potential exposure to noise and equipment hazards and strong odors.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.
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