Manufacturing Training Specialist- Permanent- Philadelphia, PA
Proclinical is seeking a Manuf. Training Specialist to join our client's manufacturing team.
Primary Responsibilities:
The successful candidate will serve as a key trainer for the A-cell therapy manufacturing program. This role necessitates experience in aseptic gowning and techniques, cell culture, and ISO class 5 cleanroom operations.
Skills & Requirements:
- Bachelor's degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
- Experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture.
- Technical knowledge of aseptic processing in cleanroom environments.
- Knowledge of and experience with in-lab skills training, including aseptic technique, cell culture processing, aseptic gowning, and qualification.
- Experience leading 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.
- Ability to accurately perform arithmetic calculations including decimals, percentages, and basic algebraic calculations.
- Proactive, results-oriented, self-starter with strong leadership skills.
- Ability to deal with ambiguity and manage constant change.
- Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
- Excellent presentation skills, both written and verbal.
- 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).
- Proficiency in Microsoft (Excel, Word, Outlook)
Preferred Skills and Knowledge:
- Experience with cell and gene therapy.
- Experience with Master Control.
The Manufacturing Training Specialist responsibilities will be:
- Develop a basic understanding of the current cell therapy manufacturing process and the equipment utilized.
- Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
- Present and deliver content to manufacturing technicians.
- Assist with the creation, review, and improvement of designated training scripts.
- Support management with the alignment of manufacturing processes with technical training.
- Help identify training needs and assist in establishing a feedback loop for continuous improvement.
- Assist with drafting SOPs, Batch Records, Deviations, CAPAs, etc.
- Appropriately escalate issues/concerns to Area Management for further investigation.
- Troubleshoot unexpected results, prioritize workload, and solve moderately complex problems.
- Work in a team environment or independently, as needed.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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