Job Description

Monday to Friday, first shift

**Candidates need to have a background in pharma/GMP, and need to have experience training people in some capacity**

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.
• 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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