Summary Description
Primary Goal:
The primary responsibility is to design, develop, and deliver PDA’s training courses both in- person and online for topics related to the various aspects of aseptic processing/sterile manufacturing of pharmaceuticals. This position will support the selection, planning, scheduling, and delivery of training courses for PDA.
The position works with volunteers and PDA staff to ensure the activities conducted are consistent with the educational objectives outlined in the current version of PDA's Strategic Plan.
Essential Duties& Responsibilities: include the following. Other duties may be assigned.
Overview
- Develops and delivers PDA training content.
- Continually evaluates courses for adherence to standards, including quality performance and specifications.
- Audits, manages, and directs courses to ensure appropriateness and exclusivity of content for target audiences
- Ensures training courses are interactive and utilize hands-on activities when necessary.
- Works with Operations to ensure propermanagement of training course equipment, instruments, materials, and supplies
- Participates in creating training course proposals for onsite training requests and when necessary; provides training course delivery if the training course subject request is related to their expertise.
- Facilitates the training needs of on-going training programs on a continuous basis.
- Works with other departments for design and development of training programs.
- Conducts the tracking and reporting of the progress for all on-going training programs, training system metrics.
- Ensures that there is consistency in the quality of training programs, initiatives, and materials.
- Provides and edits content on all marketing media.
- Writes content for PDA publications.
- Prepares and presents verbal and/or written communications concerning training courses offered by PDA.
- Participates in PDA activities (speaker at a conference/workshop, Interest groups, Task Forces, etc).
- Establishes metrics that measure the performance and success of ongoing training programs to identify points of improvement and develops solutions that improve the effectiveness of training programs.
- Works with the head of the Education department for the formulation of training strategies, initiatives, and materials that will address the identified training needs, to support the pharmaceutical industry.
- Drives innovative training program development through the facilitation/delivery of training through online and in-person resources.
- Creates, designs, and continuously improves training content, for example, outlines and presentations, agendas, associated materials, and so forth.
- Highly collaborative, works closely with various departmental heads and management in developing training activities unique to their individual departments.
Education/Experience:
A BS/BA degree or equivalent in biological, chemical, or physical science, and a minimum of 10 to 15 years’ experience in the pharmaceutical industry in the areas of aseptic manufacturing.
Sufficient experience in the development and performance of aseptic manufacturing procedures and processes directly related to the aseptic processing operations (such as process validation, deviation investigation, operator qualification, EM program, clean room operation, etc.) to be considered an aseptic processing expert.
Course and course content development and presentation experience preferred.
Competency: To perform the essential functions of this position and the job successfully, an individual should demonstrate the following competencies.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to organize, prioritize and handle multiple, time-sensitive tasks; strong oral and written communication and interpersonal skills; must be team oriented and willing to assist others with critical deadlines as needed; must understand cleanroom/laboratory processes and systems
Experience in sterile/aseptic processing pharmaceutical manufacturing environment is required.
Understanding of principles of microbiology, validation, environmental monitoring, cleanroom operations required.
Special Requirements:
Travel:
This position requires up to 75% domestic/international travel. PDA will pay for travel and expenses for travel to an onsite training, not for training conducted at TRI in Bethesda, MD.
Language Ability:
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents; ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community; ability to write speeches and articles for publication that conform to prescribed style and format; ability to effectively present information to top management, public groups, and/or boards of directors.
Math Ability:
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry; ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
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. Must be able to deal with ambiguity and analyze and determine appropriate courses of actions.
The incumbent must possess the ability to summarize and analyze instructor and course evaluations, as well as more general surveys and questionnaires.
Computer Skills:
Proficiency in MicrosoftWord, Excel, and PowerPoint.
Certificates and Licenses:
NA
Supervisory Responsibilities:
May be responsible for management of other members on the Education team. Carries out any supervisory responsibilities in accordance with the organization's policies and applicable laws.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
The noise level in the work environment is usually moderate but can become loud at times. The individual in this position should have the ability to lift and/or move supplies and/or equipment and sometimes must work near moving or mechanical parts. Laboratory functions include handling of common laboratory chemicals, solvents and cleaning and sanitizing agents.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions, as long as safety of the employee, PDA staff and faculty and students in the laboratories is not compromised.
Ability to independently lift and /or move an average of up to 50 pounds when required by work assignment.