Distribution Coordinator

About PSC Biotech

Who we are?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

Take your Career to a new Level
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition
Employees are the heartbeat of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Overview:

The An amazing opportunity has arisen for a Scientist, within the Microbiology Laboratory, at our new state of the art, single use, multi-product facility in Meath.

By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. Will provide Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch.

The Lab Operations group with work closely with Operations to understand facility fit and will be able to flex resources as needed.

As well as contributing to the establishment and day-to-day operations of our laboratory you will work across the site and network as part of a diverse and interdisciplinary team to evaluate and implement novel equipment, process and next generation technologies to keep Our Client at the forefront of innovation in development and manufacturing of biologics.

Responsibilities:

• Participate in the start-up of operations within the new laboratory facility which will include support of equipment qualification PQ protocols, documentation generation such as SOP s, Work instructions authoring and review as well as contributing to lab and process work flow establishment.
  
• Perform supporting activities for general lab operations, training, new product introduction, method verifications and method transfers.
  
• Ability to organise and establish testing schedules and adhere to deadlines.
  
• Support introduction of novel, innovative solutions supporting the microbiology lab start up of biologics within the facility.
  
• Execute in-process and drug substance analysis studies to support manufacturing, including supporting laboratory scale studies.
  
• Support technical assessments on new products in partnership with global technical teams
  
• Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop
  
• To participate in lean lab methodologies and deviation writing.
  
• Excellent trouble shooting and problem-solving skills as well as influencing, collaboration skills and teamworking ability to work with global and interdisciplinary teams.
  

Requirements

Experience, Knowledge and Skills:

Knowledge of Environmental Testing, WFI testing.

A knowledge of method transfers, scheduling would be highly desirable for Bioburden testing and in process testing for Biologics.

Technical knowledge with Biologics drug substance analytical testing.

Knowledge of design and operation of automated systems such as GLIMS, trackwise and E-logs would be desirable.

Ability to think logically and be proactive under pressure.

Ability to work as part of a team and on own initiative in a constructive manner.

Effective communicator and to be able to share and communicate that knowledge through training other analysts.

Qualifications:

A degree qualification in a relevant field (Science/Technical). An Advanced Degree (MSc) qualification is desirable.

A minimum of 2 years experience working in a relevant academic or industry field.