MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 400+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer. Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
Summary of Position
This position is responsible for overseeing the GxP training program at MacroGenics. This individual will interface with management to identify the appropriate training curriculums for all applicable positions and to ensure systems are updated to reflect those requirements. Will also be responsible for driving improvements to the training program based on regulations and best practices. They will manage the trainer the trainer programs and address and resolve GxP training related issues and concerns.
Responsibilities and Job Duties:
- Reviews the current process for identifying appropriate training and makes recommendations for any improvements. Facilitates discussions about the current system to ensure it is most appropriate for current employees and new hires. Executes on current process and implements any necessary changes to ensure that each position is assigned the required training curriculum. Provide consultation/support to document authors and functional area management as it pertains to training assignment design.
- Manages the development of various training media such as power points, videos, topic specific training modules to make training more user friendly and efficient and ensure systems and position assignments are updated accordingly
- Conducts regular feedback sessions with department heads on the training program in order to determine if improvements are needed. Make recommendations that are appropriate to Quality management team with proposed action plans.
- Manages the roll out of all new training programs. Develop mechanism for capturing feedback and process for making improvements.
- Evaluates all GxP training material to ensure that its meets specified criteria necessary for approval within MasterControl. Ensure that GxP training material is on a formalized review cycle so that it can be determined if still suitable or if modification is needed. Makes recommendations for appropriate changes and gather needed approvals.
- Formalizes the train the trainer programs utilizing the best capable employees. Evaluates “certified” trainers for continued qualified status and for overall performance and provide constructive feedback on periodic basis.
- Identifies approach to creating best practices and metrics to drive training compliance. Makes recommendations to Quality management team and implements approved plans.
- Identifies required training for contractors, maintain contractor paper-based training files and ensure that contractor job codes are in place and updated when needed.
- Revises relevant training SOPs and forms that support the training program and make improvements as necessary.
- Trains GxP departments on the use of, and the functionality and capabilities of the training module within MasterControl.
- Organize and executes annual GMP training event. Develop mechanism for obtaining feedback and explore areas for improvement.
- Assists with special QA projects and other duties as assigned.
Education & Credentials
- Associates’ degree in biotechnology or a related life sciences field of study
- Five (5) years of professional level experience in Quality Assurance in a GMP regulated manufacturing facilities
- Eight (8) years of experience in Quality in a biotech or pharmaceutical company
- One (1) year of experience coaching, mentoring, or training others or experience supervising or leading individuals on projects
- Prior experience with instructional design and developing training programs
- Experience with paper-based and electronic document management systems
- Prior experience in a commercial environment in the pharmaceutical industry
Knowledge, Skills and Abilities
- Ability to communicate effectively with subordinates and with peers and other management levels
- The capability to recognize changes in priorities and make adjustments as needed
- Ability to influence without direct authority
- Demonstrated ability to engage and motivate employees
- Must be able to manage multiple projects at once
- Proficient using MicroSoft Office, specifically with MicroSoft Word, Excel and Powerpoint
- Prior experience with Master Control preferred
- Train the Trainer or similar certification a plus
MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email [email protected] or call (301) 354-3566 and/or 711 for TTD/TTY service.
Equal Opportunity Employer/Veterans/Disabled
We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.
To promote the health and well-being of our employees and ensure business continuity, MacroGenics requires all new hires to be fully vaccinated for COVID-19 by his/her start date. A new hire will need to either (a) establish that they have been fully vaccinated or (b) obtain an approved exemption as an accommodation.