Your primary responsibilities will include:

• Responsible for clinical manufacturing novel cell therapy drug substance within the Cell Therapy Module, CT-MOD.
• Collaborates closely with biological development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensures platform alignment.
• Works with a single-cell line from expansion, through differentiation and fill/finish process to manufacture a unique product using single-use technology.
• Manufactures products in various phases of product life cycles from clinical through launch.
• Responsible for all aspects of clinical manufacturing in the following areas: Solution Preparation, Cell Expansion, Cell Culture, and Final Fill and freezing.

In addition, you will:

• Ensure all activities are performed to schedule.
• Clearly understand, communicate, and manage differences in terms of documentation, sample handling, automation, cGMPs, etc. for different phases of the product life cycle.
• Author, redline, and review-controlled documents for various equipment/processes.
• Monitor and control processes using data trending and/or statistical process control.
• Work cross-functionally to ensure process is controlled and issues are escalated and investigated.
• Raise and support investigation of deviations.
• Partner cross-functionally to determine product impact and root cause.
• Implement and execute manufacturing tasks in alignment with effective corrective actions to prevent re-occurrence.
• Participate in regulatory and internal audits.
• Support commissioning and qualification of equipment.
• Participate in safety investigations for CT-MOD and always promote safe behaviors.
• Partner cross-functionally to identify and implement corrective actions.

If you have experience in pharmaceutical operations, preferably biotech or an equivalent combination of education and experience, and possess a strong understanding of FDA, EMA, etc., and cGMP requirements for pharmaceutical manufacturing, we encourage you to apply for this exciting opportunity.

We offer a competitive salary range of $64,000.00 – $97,000.00, additional compensation may include a bonus or commission (if relevant), and a comprehensive benefits package, including health care, vision, dental, retirement, PTO, sick leave, etc.

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