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Job type: Permanent

Discipline: Immunology

Location: United States

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.

INDSCIC