Operations Expert

Company –

Here at Scienta, we are teaming up with a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. They are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy.

As an Operations Expert, you will be part of the manufacturing operations team responsible for production of cell therapy products for clinical and commercial operation in a controlled current Good Manufacturing Practice cleanroom environment. You will lead and perform multiple units within the Therapy process operations (i.e., component preparation manufacturing, manufacturing support operations, fill & finish, and cryopreservation) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations.

Responsibilities –

• Support building the GMP documentation package to ensure timely execution of production operations per cGMP compliance.
• Execute production activities common to manufacture clinical & commercial grade ATMPs by aseptic manual process.
• Work daily in a cleanroom manufacturing environment (Grade A/B/C/D)
• Manage the daily production planning in a routine production flow.
• Support manufacturing investigations, create/revise operational procedures, including
  manufacturing work instructions, master batch records, forms, and support and manage
  change controls.
• Acts as Production Expert in the field by training and coaching junior production technicians.
• Support the Testing and implementation of various manufacturing execution system
  software.
• Support the development of manufacturing processes, participate in Lean & Operational excellence project.

Experience –

• Bachelor’s or Master’s degree in science, Bio-Engineering, Biotechnology, Pharmacy or related field or equivalent experience required.
• 3 years of operations experience within a GMP regulated environment in the biotech/biopharma industry.
• 3 years’ experience in aseptic techniques in clean rooms.
• Experience working in cGMP systems including PASx, eLIMs, Siemens, and SAP is preferred.
• Ability to accommodate changes in the schedule including working in other shifts, evenings, and weekends as per operational needs is required.