Technical Trainer, Cell Therapy
at Lonza Walkersville, Inc.
Posted in Science 30+ days ago.
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Location: Walkersville, Maryland
At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.
We strive to be the leading supplier using science and technology to improve the quality of life.
We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
Do you want to help us as we shape the future of this great organization?
Job Description Summary
The Cell Therapy (CT) Trainer is responsible for working with the Cell Therapy Manufacturing team and the Training Department in order to identify departmental technical training needs and implement appropriate and comprehensive training curricula. Responsible for facilitating and conducting technical training. The CT Trainer is responsible for conducting on-the-job training utilizing experience, established procedures, processes and techniques to ensure Manufacturing Technicians have the skill sets needed to perform their job function to their fullest capability. CT Trainer establishes and revises training materials - including but not limited to – videos, guides, SOPs, LQMs, PMs, and Work Instructions that are utilized to train all manufacturing personnel in the various procedures and programs that run in manufacturing; including, but not limited, to aseptic processing and qualification, cell culture technique, regulatory requirements such as GMP Documentation, cleanroom behavior, cGMP/ISO, and laboratory safety. Participates in SOP revisions as well as continually improving the training program responsible for facilitating and conducting technical training for the Cell Therapy Manufacturing Department, including but not limited to aseptic processing and qualification, GMP Documentation cleanroom behavior, cell culture technique, cGMP/ISO, and laboratory safety. Participates in SOP revisions as well as continually improving the training program. Creating and/or revising training materials including but not limited to – videos, guides, SOPs, LQM, PM, and Work Instructions.
Key Accountabilities and Duties:
- Serves as primary technical trainer in order to facilitate and conduct on-the-job training for Manufacturing personnel; for both the effective induction of new hires into Cell Therapy Manufacturing as well as, the ongoing improvement and proficiency of Manufacturing Technicians within the department, by delivering on-the-job technical training on a timely basis, including new hire emersion training, aseptic technique and processing, cell culture basics, Cell Therapy specific equipment training, cGMP documentation and regulatory basics, as well as general lab skills.
- Demonstrates mastery knowledge of Aseptic Cell Therapy Manufacturing and production.
- Evaluates job proficiency and skills while correcting and coaching workmanship and technique by completing operator evaluations or proficiency assessments during production activities, and provide feedback and communicate feedback and issues to managers.
- Provides feedback and actively mentor Manufacturing Personnel while providing leadership during often stressful demands of the production floor
- Facilitates timely resolution and closeout of Corrective and Preventative actions specific to CT Training issues
- Partners with Cell Therapy Manufacturing and the Training Department to identify technical training needs and design and implement an effective and comprehensive training program for the Cell Therapy Manufacturing Department while identifying improvements to the existing Cell Therapy training curriculum.
- Establishes and/or revise educational training materials including but not limited to – videos, guides, SOPs, LQMs, PMs, and Work Instructions.
- Collaborates with the Training Department to identify and schedule technical training needs; development, delivery, and documentation of technical training.
- Maintains and updates LSO Profiles for Cell Therapy Operators.
- Coordinates Operational Excellence (OE) initiatives.
- Participates in and/or contribute to advanced DMS workflow activities (i.e. editing SOPs and training material).
- Provides technical writing support for training related processes and procedures.
Minimum Required Qualifications/Skills:
- Bachelor’s Degree in preferred area of study: Cellular Biology (or like field) OR High School Diploma or Equivalent with 5-7 years of experience in cGMP manufacturing environment AND experience in aseptic techniques and skills, Cell Culture basics, and cleanroom behavior.
- 5+ years of experience in a cGMP environment
- Experience in Cell Culturing and Aseptic Technique in an ISO 5 Environment Required.
- 2+ years of experience in a training role preferred (particularly On-The-Job Training)
- Parenteral Drug Association (PDA) Aseptic Processing Training preferred
- Knowledge of aseptic techniques and skills, Cell Culture basics, contamination control, serological methods, and cGMP and clean room behavior required
- Knowledge of biopharma laboratory and/or manufacturing experience preferred
- Aseptic technique and experience in cell culture and serological methods preferred
- Able to pass Class 10,000 gown validation
- Computer software skills including Microsoft Office and SAP, organization skills, recordkeeping skills, ability to manage multiple projects, time management skills.
- Written and oral communication skills, interpersonal skills, team oriented, independent work skills, strong work ethic.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
Lonza. The place to Go, Stay and Grow.
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