Manager, Tissue Manufacturing - Celularity Inc

Celularity is seeking an experienced dynamic individual to lead a motivated team of clinical operators and manage the daily manufacture of multiple tissue therapy products in support of the company’s clinical stage platforms. Leveraging Celularity’s new, state-of-the-art cGMP capable facility, this position will make use of existing innovations and future technologies to meet and exceed manufacturing demand.

• Lead, mentor and train operators responsible for the technical manufacture of the company’s tissue therapy products. Strong working knowledge of classified manufacturing environments and clean room suites. Ability to gown appropriately for clean room/aseptic manufacturing is required.

• Work cohesively with cross-functional teams in support of operational efficiency, flexibility, and assurance of timely completion of all manufactured tissue therapies. Ensure the delivery of sufficient supply of tissue products for clinical studies in accordance with company timelines and participate in clinical supply campaigns.

• Manage daily, routine product manufacturing and related tasks. Assure completion of daily manufacturing workload. Oversight of schedule for direct team members.

• Develop and implement technically sound Tissue Manufacturing batch records, SOPs, protocols, and specifications as required, while adhering to good documentation practices (GDP).

• Serve as the Subject Matter Expert (SME) and use knowledge of scientific techniques to troubleshoot processing or product quality issues with a sense of urgency.

• Ensure overall inspection readiness for area of focus and participate as an SME in agency inspections.

• Lead the receipt of technical transfers from Process Development (PD) Team, ensuring appropriate equipment purchase, assisting with processing COGs and timelines, and initiating manufacturing suite set-up.

• Lead deviation investigations and support on-time closure of deviations and CAPAs for areas of focus.

• Provide routine feedback and updates to departmental leadership on product/process KPIs and participate in the delivery/communication of established functional strategies to production team.

• BS degree in Biology, Bioengineering or related scientific discipline.
• 6+ years’ relevant experience with tissue manufacturing, gowning, and operation within cGMP environments. Understanding of federal regulations for Quality Systems (21CFR820) and GMP manufacturing (21CFR 210,211).
• Strong knowledge of GxP regulations (cGTP, cGDP, cGMP)
• Strong organizational and time management skills.
• Ability to work well in a team environment, eager, adaptable.
• Excellent verbal and written communication skills as well as strong focus and attention to detail.
• Ability to perform frequent physical tasks with strength and mobility. Daily tasks call for routine walking and standing in cleanroom environments and occasional lifting of heavy materials.
• Flexible scheduling required.
• Demonstrated scientific creativity, technical proficiency, and knowledge of scientific concepts
• Experience in a fast-paced, scientific start-up environment
• Dynamic individual with the ability to communicate and engage others
• Independent and self-starting.

Working Conditions

• Position primarily operates for extended periods of time in classified clean room environments. Daily gowning in company provided scrubs, PPE and clean room attire.
• Fast paced, start-up environment which may periodically require work beyond standard business hours.
• Must be able to lift and transport at least 50 pounds
• Handling of potentially biohazardous material (human cells, tissues, etc.).