Lead, Clinical Manufacturing

About Celularity

Celularity Inc. (Nasdaq: CELU) is a regenerative medicine company developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, all derived from the postpartum placenta. Its therapeutic programs target aging-related diseases, including degenerative diseases, cancer, and immune disorders, using mesenchymal-like adherent stromal cells (MLASCs), T-cells engineered with CAR (CAR T-cells), and genetically modified and unmodified natural killer (NK) cells.

Summary

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

Responsibilities will include, but are not limited to, the following:

• Lead, mentor and train operators responsible for the technical manufacture of cell 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 cell therapies. Ensure the delivery of sufficient supply of cellular products for clinical studies in accordance with 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 Clinical 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 inspection, accreditations or any regulatory audits
• Lead the receipt of technical transfers from Process Development (PD) team and/or 3rd party collaborations. Adhere to established timelines and initiate manufacturing suite-set up and readiness.
• 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.

Minimum Qualifications (Must have)

• B.S degree in Biology, Bioengineering or related scientific discipline.
• 5 years’ relevant experience with clinical 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 laboratory environments. Daily gowning in company provided scrubs, PPE, etc.
• 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.).
• Daily tasks call for routine walking and standing in cleanroom environments and occasional lifting of heavy materials.

Cleanroom/Laboratory Health and Hygiene Requirements for the role include but are not limited to:

• Adherence to stringent health and hygiene standards: Personnel must comply with strict cleanliness protocols to ensure the integrity of Celularity's controlled environments and contamination control policies.
• Personal hygiene: Regular personal hygiene practices are required, including frequent bathing, handwashing, and maintaining clean, trimmed hair (including facial hair) and nails to minimize contamination risks.
• Health status: Employees exhibiting symptoms of illness, including colds, infections, or other conditions that could lead to contamination, are prohibited from entering cleanroom environments to safeguard product quality and safety.
• Dress Code Compliance: The use of makeup, false eye lashes, nail polish/gel, hair spray, temporary or semi-permanent hair dyes, jewelry, or any other personal items that may transfer contaminants is strictly prohibited in cleanroom and laboratory environments.
• Training and gowning: Successful completion of regular gowning qualifications is mandatory. Employees must demonstrate continuous adherence to gowning procedures and all established cleanliness and hygiene protocols to maintain a sterile environment.

Celularity Inc. is an equal opportunity employer