This position is responsible for the operation of PDA Training and Research Institute (TRI) to include training development, budgeting, selection, planning, and delivery. This position is also responsible for the management of PDA’s training facility in Bethesda, MD, ensuring the facility is operational and efficiently utilized, along with sourcing and supporting training facility locations globally.

This position is responsible for ensuring the continued success of PDA TRI by maintaining and growing existing business and pursuing new business through potential training event, facility, and partnership opportunities.

The ideal candidate must be ambitious with a desire to lead and grow the department. They must be self-driven with a positive attitude and sense of ownership for their work. Experience in aseptic processing and contamination control within the pharmaceutical manufacturing industry is preferred.

Essential Duties and Responsibilities (other duties may be assigned) 

Training Development and Delivery

• Ensures development and delivery of PDA training content and coordination of external trainers delivering content.
• Ensures training events are interactive and utilize hands-on activities when necessary.
• Works with other departments and external sources for design and development of training events.
• Ensures consistency in the quality of training events, initiatives, and materials.
• Works with the VP of TRI to provide and edit all marketing media for TRI.

Training Event Management

• Works with the VP of TRI to ensure metrics that measure the performance and success of ongoing training events are in place to identify are performing well and those where improvement is needed.
• Prepares and presents verbal and/or written communication regarding PDA TRI training events when requested.
• Develops, establishes, and maintains systems, processes and procedures in support of training event delivery.
• Manages master training event schedule by reviewing PDA and competitor organization event schedules for potential conflicts, analyzing historical performance, and understanding current industry landscape and needs.
• With the VP of TRI, audits training events and materials to ensure appropriateness and exclusivity of content for target audiences.

Business Development and Partnerships

• Works with the VP of TRI to identify opportunities for campaigns, services, and distribution channels that will lead to an increase in revenue or decrease in operating costs.
• When requested by the VP of TRI presents to and consults with industry professionals on business trends with a view to developing new training events or revising existing training event offerings.

Operations Management

• Works with the Vice President of TRI for the formulation of training event strategies, initiatives, and materials that will address the identified training event needs to support the industry.
• Facilitates resolution of quality and operational issues in a timely manner.
• Ensures training facility in Bethesda, MD, is maintained and utilized efficiently.
• Ensures other training facilities being used for TRI courses are adequate for delivery of training events
• Works with the Vice President of TRI to manage training event supplies along with maintaining existing supplier partnerships and seeking new partnerships
• Ensures department’s Standard Operating Procedures (SOPs) are up to date
• Facilitates resolution of operational issues in a timely manner

Department Leadership

• Supervises TRI staff (coordinators, etc.) (Direct Reports)
• Represents PDA TRI as a part of the Education Advisory Board.
• Coordinates communication with internal cross functional teams for quality issues.
• Provides exceptional leadership skills to the organization including hiring, mentoring, and developing staff

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 abilities 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 laboratory processes and systems.

Experience in sterile product operations, including aseptic processing and contamination control, is preferred.

Education/Experience

A BS/BA degree or equivalent in biological, chemical or physical science is preferred. Facility management experience and a minimum of 2 to 5 years in the pharmaceutical or equivalent industry in the areas of aseptic manufacturing, biological, chemical or physical sciences preferred.

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. Must possess the ability to summarize and analyze instructor and training event evaluations, as well as more general surveys and questionnaires.

Computer Skills

Proficiency in Office 365 (Microsoft Word, Excel and PowerPoint), Building Management Systems, Human Machine Interfaces, Learning Management Systems, Website Design and Management.

Supervisory Responsibilities

Responsible for the management and leadership of 2 training staff. Carries out 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/equipment and sometimes must work near moving or mechanical parts. Laboratory functions include BSL-2 management and handling of common laboratory chemicals, solvents and cleaning and sanitizing agents. On a limited basis, the individual occasionally works around fumes or airborne particles or with toxic and/or caustic chemicals.

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 accommodations may be made to enable individuals with disabilities to perform the essential functions, as long as safety of the employee, staff, instructors, and attendees in the laboratories are not compromised.

The employee must be capable of lifting and/or moving an average of up to 50 pounds. 

About Parenteral Drug Association

The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its nearly 10,000 members worldwide.

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