Department: Azzur Training Center - Raleigh, LLC
Expected Salary Range: 100,000-125,0000
Cell Therapy or Gene Therapy experience required.
The Sr. Training Specialist (CGT) primary role is to deliver cGxP training content on multiple technical
subjects at the Training Center and at client sites across the US. Additionally, they will support all
functions related to creation of technical training content with a focus on exceptional customer service
and subject matter excellence. This individual will also work closely with the Manager/Director of
Training to identify, develop, and support the implementation of progressive competency-based
technical training programs, ensuring consistency, compliance, and effectiveness within and across
internal and external clients. Travel may be required to support client training projects.
- Responsible for developing and delivering engaging and memorable learning experiences in a classroom and cleanroom setting to personnel of all backgrounds.
- Specifically - Provide technical knowledge surrounding ATMP (Advanced Therapy Medicinal Product) or CGT (Cell and Gene Therapy) to develop specific training programs.
- Function as part of a team to create, update, and deliver training presentations and supporting material to ensure compliance with industry best practices.
- Monitor changes to industry legislation and guidance documents to maintain best practices in our training space.
- Attend and/or speak at industry Trade Shows on behalf of ATC
- Contribute to strategic technical / training / project direction through regular team meetings
- May act independently toward long-range goals and objectives
- Empowered to exercise latitude in determining training objectives
- Act as a role model / mentor / trainer to other team members
- Bachelor’s degree in Engineering or Life Science required
- Master’s degree in Engineering, Life Science, Business
- Required Work Experience
- 8+ years (BS), 6+ years (MS) of experience in a cGMP Life Science Manufacturing facility in any of the following areas: manufacturing, quality, training, laboratory, packaging, supply chain, validation, investigations, complaints, auditing, safety, maintenance, etc.
- Work in gene therapy, cell therapy, biologics, or vaccine manufacturing facilities.
- Training individuals / groups on any subject.
- Technical writing including Standard Operating Procedures (SOPs), protocols, investigations, reports, etc.
- Federal Regulations, U.S. Food and Drug Administration (FDA), current Good Manufacturing
- Practices (cGMPs), Good laboratory practices (cGLP), Good Clinical Practices (cGCP), Good Cell and Tissue Culture practices (GCCP), United States Pharmacopeia (USP), International
- Conference on Harmonization (ICH), and other applicable industry guidance documents.
- Familiarity with ATMP (Advanced Therapy Medicinal Product) or CGT (Cell and Gene Therapy) aseptic processing concepts and regulatory requirements.
- Proficiency with key cGXP principles and expectations.
Preferred Experience / Knowledge:
- Direct experience and working knowledge of aseptic manufacturing techniques and supporting equipment, including but not limited to: Cleanrooms, Isolators, BSCs, Laminar Air Flow Hoods and/or RABS
- Experience performing aseptic manufacturing, manipulations, and interventions
- SME level knowledge in any major manufacturing area described above
- Familiarity with Adult Learning Theory
- Familiarity with Global Regulatory requirements
- Production of human gene therapy products, cell-based therapies, ATMPs
Skills (i.e. Typical Mental/Physical Demands):
- Must be fluent in English.
- Works under limited supervision
- Strong attention to detail
- Flexible, adaptable, and capable of delivering in a fluid environment
- Ability to exercise judgement to determine appropriate corrective actions
- Persuasive written and verbal communication skills
- Proficient listener
- Proficient in Microsoft Office: Word, Excel, PowerPoint / LMS and Google.
- Work in an aseptic environment in gowning attire for extended periods of time (up to 3 hours).
- Translate technical and procedural information into training materials.
- Excellent client service and relations
- Interpret a variety of instructions furnished in written, oral, and diagram or schedule form.
- Ability to work flexible shifts on an occasional basis, and travel as required for project assignments (up to 25%).
Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers, and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.
Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.