Job Description
The Training Specialist I will be a trainer for the autologous cell therapy manufacturing program. A background in cell culture, aseptic technique, aseptic gowning and qualification and ISO class 5 cleanroom operations is required.
Essential Functions and Responsibilities
- Develops a basic understanding of the current cell therapy manufacturing process and the equipment utilized during processing, as this role is viewed as a subject matter expert (SME) within this specific area.
- Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements; Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
- Presents and delivers content to manufacturing technicians.
- Assists with the creation, review and improvement of designated training scripts; On the Job and Instructor Led Trainings (OJTs and ILTs).
- Supports management with the alignment of manufacturing processes with technical training, ensuring consistency.
- Helps to identify training needs; assists in establishing a feedback loop to ensure continuous improvement.
- Assists with drafting SOPs, Batch Records, Deviations, CAPAs, etc. Performs revisions as needed to accurately reflect current procedures.
- Appropriately escalates issues/concerns to Area Management for further investigation.
- Works on assignments that are moderately complex in nature, where judgement is required to resolve or escalate operational issues without negatively impacting manufacturing efforts.
- Troubleshoots unexpected results, prioritizes workload and solves moderately complex problems.
- Possesses ability to work in a team environment or independently, as needed.
- Must adhere to core values, policies, procedures and business ethics.
- Complies with Safety SOPs, SDS sheets and laboratory procedures per company policy and OSHA regulations.
- Performs miscellaneous duties as assigned.
Required Education, Skills, and Knowledge:
- Minimum bachelor’s degree (B.A./B.S.) in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience
- Minimum of 2 years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Technical knowledge of aseptic processing in cleanroom environments is a must.
- Knowledge of and experience with in-lab skills training, including aseptic technique, cell culture processing, aseptic gowning and qualification is a must.
- Experience leading “development” initiatives such as training, coaching/mentoring, learning initiatives.
- Ability to mentor and provide best practices to new employees.
- Ability to build relationships quickly and provide consistent, excellent support to staff, with the ability to influence large teams within the manufacturing environment, representing a variety of personalities and experience levels.
- Ability to accurately and reproducibly perform arithmetic calculations including decimals, percentages and basic algebraic calculations.
- Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
- Ability to deal with ambiguity – ready to change gears and plans quickly, with the need to manage constant change.
- Ability to work successfully in a fast-paced team-oriented setting.
- Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
- Excellent presentation skills, both written and verbal.
- Understands and complies with quality standards and requirements as documented.
- Must have strong written and verbal communication and organizational skills.
- Strong computer skills, problem solving and attention to detail.
- Familiarity with data and sample management required (LIMS/MES).
- Working knowledge within a Learning Management System (LMS).
- Able to work independently with minimal supervision.
- Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).
Preferred Education, Skills and Knowledge:
- Experience with cell and gene therapy.
- Experience with Master Control.
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