Shivam Desai

· Aseptic processing of mRNA and LMX/LNP to formulate clinical & commercial drug substance using Moderna specific technologies including chromatography, multiple filtration methods and nano-mixing operations.

. Utilize the manufacturing support systems and equipment as required including, but not limited to, SAP, VEEVA, Delta V, Syncade, LIMS, CMMS.

· Practice safe work habits and adhere to Moderna’s safety procedures and guidelines.

· Follow all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.

· Execute tasks precisely. Utilizing reader-doer for all steps outlined in standard operating procedures, work instructions, and batch execution documentation. Readers are responsible for SOP and batch record compliance, verifying the actions of the Doer, and are accountable for the outcome of the tasks. Doers are responsible for task execution, are expected to understand the task's purpose and are expected to be able to anticipate system response once actions are performed.

· Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.

· Working in grade C environments and ensuring the manufacturing area is clean and remains in a state of control.

· Adhere to documented waste handling procedures and respect environmental regulations.

· Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence of gowning and vision, if applicable.

· Utilize the manufacturing support systems and equipment as required including, but not limited to, SAP, VEEVA, Delta V, Syncade, LIMS, CMMS.

· As a Qualified Trainer, perform On the Job Training (OJTs) to accelerate the assimilation and training of colleagues on unit operations and supporting business processes.

· Understands physical and digital systems governing equipment and processes to enable basic troubleshooting.

· Perform specific unit operations in which they are fully trained.

· Filling and dispensing activities to final container closure for finished clinical and commercial drug substance prior to forward processing.

· Able to approve document revisions as delegated by their manager.

● The Pharmaceutical Operator will operate the equipment to manufacture client pharmaceuticals and repair/maintain equipment as necessary.

● The Pharmaceutical Operator will operate the equipment to manufacture client pharmaceuticals and repair/maintain equipment as necessary.

● Maintenance of calibration logs/status and upkeep of material calibration

● Ensuring sufficient stock levels are maintained for machine consumables/area consumables such as Hepa filters

● Performance of IQ/OQ for new equipment where required

● Ensuring sufficient stock levels of consumables and appropriate PPE are kept

● Production of risk and COSHH assessments for activities undertaken within the area

● Maintenance and updates to Production Checklists where necessary

● Ensuring GMP Clean Room Area environmental status is within specified limits prior to use

● Waste disposal of Pharma waste and solvent waste

● Working in a Health & Safety conscious manner following safe systems of work

● Project Specific manufacturing activities, including room set-up, production, packing, room clean down, label production, checking, and other associated activities

● Production of working protocols, or batch documentation for production exercises in line with standard ways of working within the department

● Ensuring all documents are checked and approved prior to undertaking production exercises

● Recording all production undertakings in line with GMP and completion of all documentation to achieve a ‘right first time’ standard of work. In line with SGS Quay’s OP’s and to report any deviations through SGS Quay’s quality system

● Reporting where required in standard SGS Quay Pharma format in line with SOP’s/standard ways of working

working

● Executed routine manufacturing assignments according to written procedures with minimal instructions

● Proficiency in documenting manufacturing processes, including batch records, SOPs, and logbooks.

● Familiarity with Good Manufacturing Practices (GMP) and regulatory guidelines specific to the biopharmaceutical or biotechnology industry. Knowledge of FDA regulations and guidelines is often necessary

● Assume responsibility for overseeing and regulating the inventory levels of materials and components.

● Ability to analyze process data, perform calculations, and interpret results accurately.

● Running and handling automatic machines in the cleanroom.

● Prepare a media solution for bacterial growth.

● Troubleshooting problems and errors on the automation machine.

● Calibration check on systec media.

● Practice and followed cGMP.

● Process document data through batch records.

● Worked on Systec media development.

● Final inception of cassettes and approved for packaging.

● Practice and followed cGMP.

● Inspected finished products for quality and adherence to customer specifications.

● Performing in process inspection of CMM.

● Developed and maintained courteous and effective working relationships. ● Worked on KDF, SUSS, Top Coat, Base Coat.

● Trains for proficiency in the operation of primary production equipment within the assigned functional area (i.e. bioreactors, chromatography skids, media or buffer preparation equipment etc.).

● Performing shipping task from sales order to dispatching

● Provided needed support to team leads and supervisors complete documentation.

● Kept production logs and maintained job material inventory.

● Replenished condiments, beverages, and supplies while maintaining the cleanliness of service areas.

● Audit of machine before production starts up.

● Checked completed orders for accuracy and bagged meals for easy carrying.

● Working with senior management to manage large and complex production tasks.

● Assisted management with inventory control and stock ordering.

● Reported non-conforming results and trends to supervisor for corrective action