Production Pharmacist

BIONET (Ayutthaya)

Ayutthaya, Thailand

BioNet is a biotech company focusing on bio-innovation and access to genetically-designed vaccines. BioNet is the world’s only manufacturer of licensed recombinant pertussis vaccines containing a genetically-inactivated pertussis toxin (PTgen). BioNet’s vision to forge global product partnerships has led to the rapid development of genetic vaccines using DNA and mRNA technology platforms. Clinical development of BioNet COVID-19 DNA candidate vaccines are conducted in Australia by Technovalia and partners. BioNet has been manufacturing a mRNA COVID-19 vaccine developed by Chulalongkorn University and the University of Pennsylvania. BioNet is now developing a pancoronavirus mRNA vaccine with the support from CEPI. BioNet is leading a global consortium composed of US and Thai universities and the International Vaccine Institute.

About this position

The role of Production pharmacist is to monitor that the routine production activities in primary and secondary manufacturing comply with GMP regulations and requirements and approve the batch manufacturing records accordingly. To ensure strict compliance with Pharmaceutical Good Manufacturing Practices according to Thai Law (equivalent to PIC/s GMP and other relevant GxPs as well as Marketing authorization).

Responsibilities

• Monitoring the manufacturing process (primary and secondary) and approval of batch production records.
• Check adherence to GMP compliance as per regulatory requirements.
• Responsible for shop floor level working program implementation; Hands on working, monitoring, supervision and control of various production activities and reporting of the events to the department Manager.
• Monitoring for the compliance to gowning, health and safety practices, Biosafety practices as per the regulatory or law requirements.
• Preparation and review of Batch production records, SOP, protocols, lab notebooks, SOPs, log books and other documents as per the regulatory requirements.
• Coordination with the other departments for routine production activities.
• Handling of equipment, supervision and maintenance follow up with complete documentation.
• Facility commissioning, validation and monitoring.
• Managing workload and time to perform multiple projects or activities effectively.
• Periodic participation to internal audits, training programs, departmental reviews, meetings etc.
• Perform other related duties as may be reasonably assigned in the course of business.
• Other jobs assigned by superiors to support the organization achievement as well as cooperation in company rule and regulations, safety policy and all activities according to company policy.
• Report any incident, accident, near miss and any violations of the HSE or safe work practices including malfunctioning of the equipment or workplace hazards that he/she is aware of to the direct supervisor.
• Follow the health and safety procedures related to the job functions, which includes the use of Personal Protective Equipment (PPE), safe operation of equipment, machinery, tools and handling of hazardous substances.

Requirements

• Bachelor or Master is preferable.
• 2-3 years of experience in Pharma or vaccine (Biological) Industry.
• Strong scientific background and technical skills.
• Possess project management skill and knowledge.
• Good communication skills.
• Competent in planning and organizing, people management, decision making, negotiation and conflict management.
• Fluent in both written and spoken English.
• Good knowledge of GMPs/GLPs and other relevant GxPs.