Laboratory Systems Lead

About PSC Biotech

Who are we

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.

Job Purpose

• This role will be part of the Technical Operations Team which is part of the Biologics AR&D in our single use multi-product Biologics facility .
  
• The Laboratory Systems Lead will work across the site and AR&D to drive proactive programmes to allow the site to deliver the pipeline. The Laboratory Systems Lead will be responsible for supporting the implementation and configuration of Laboratory Systems . This role will support the laboratory teams for testing of incoming raw materials in-process drug substance/drug product stability samples. This role will build the Lab IT Systems to support Tech Transfer/Commercialisation of the biologics pipeline.
  
  

Requirements

Key Responsibilities:

• SME on data management systems for instrument control in the laboratories this includes but is not limited to LIMS Waters Empower LabX Softmax Pro and other laboratory instrument controlling software.
  
• Build the Lab IT Systems to support Tech Transfer/Commercialisation and manufacturing of Biologics. Monitor and support the performance of the site Laboratory Systems according to cGMP and Systems Development Life Cycle (SDLC) standards such as change control and document management.
  
• Responsible for implementing industry best practices specific to Laboratory Systems processes that support sample management testing and validation.
  
• Ensure site Laboratory Systems comply with changing requirements and trends in worldwide GMPs.
  
• Deliver training to relevant personnel on the correct application of the site Laboratory System procedures.
  
• Pro-actively participate in processes to ensure that the Laboratory Systems continue to function effectively and that improvement/remediation actions are taken such as Change Controls Documentation Management CAPAs and Audit Readiness.
  
• Continuous improvement of the Laboratory Systems - Identifying and building in efficiencies as necessary from a systematic and compliance perspective.
  
• Provide SME support for general troubleshooting problem solving technical direction and guidance to support overall business needs.
  
• Creates an environment of right first time in everything that we do through a focus on principles of lean including simplification standard work visual management and a learning organisation.
  
• Responsible for timely updates of site achievements and challenges. A collaborative approach working cross functionally on resolving obstacles to maintain a highly effective and productive functional group.
  

Educational and Experience Requirements:

• Degree qualification in a Technical discipline e.g. (Biochemistry /Chemistry /Engineering).
  
• At least 2 years experience in Laboratory Systems.
  
• Previous experience with configuring building maintaining laboratory management systems such as LIMS LabX Empower systems and an interest in coding/ script.
  
• Experience working in a GMP Regulated Pharma/Biopharma company or related industry is desirable.
  
• Have an understanding in analytical methodology (e.g. HPLC ELISA Glyco analytic Bioassays PCR capillary electrophoresis compendial assays).
  
• Have a working understanding of GMP ICH USP and global compendia regulations and guidances particularly as related to analytical method development and validation
  
• Excellent communication skills (written and oral).
  
• Strong technical aptitude (i.e. able to read write and comprehend technical documentations and execute procedures).
  
• Proven ability around working cross functionally focusing on meeting and tracking to schedules and embracing an interdependent work culture.
  
• Organisation Skills Ability to manage multiple priorities and know when to escalate issues for resolution.
  
• 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.
  
• Flexible and self-motivated