Job Description
Job Description
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 points 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 through 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.
- We are hiring a Bioassay Technical Specialist.
- This is a position requiring someone with strong analytical experience to provide multidisciplinary expertise and technical support to the Analytical Sciences team and commercial testing laboratories. The successful candidate will be responsible for leading the effective and efficient running of Analytical Bioassay and ELISA methodologies both globally and locally, Analytical Method Transfers, Validations, Investigations and Change Control.
- The successful candidate will demonstrate a high level of technical leadership, collaboration, coaching and mentoring to facilitate the team in becoming a high performing organisation and ensuring timely delivery of projects. Central to this objective will be the active engagement and communication with all internal and external stakeholders. A high level of innovation, enthusiasm and drive will also be required to deliver technical excellence for analytical methods.
Requirements
What you will do:
- Good knowledge of working practices required for working in a Bioassay laboratory (e.g. ELISA, cell biology, cell culture, protein biochemistry etc.)
- Support assay optimisation/investigations within the Bioassay area
- Analytical Technology Transfer
- Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.
- Lead the delivery of projects whilst adhering to project timelines using project management tools.
- Lead cross-functional problem-solving teams for troubleshooting, and investigations within local Quality, other Sites within the network and contract laboratories as required.
- Commissioning and Qualification of various lab equipment and design and execution of assay and equipment validation studies and lifecycle management of Bioassays.
- Engage in ongoing Bioassay performance monitoring.
- Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.
- Actively pursue development opportunities to increase the skill set and experience within the group through continuous education, job rotation, cross-functional training, Lean Six Sigma, etc.
- Collaborate with internal partners (i.e. other sites, R&D) and externally with CROs.
What skills you will need:
- BSc in a relevant Science discipline
- Experience with ELISA/Bioassays and leading analytical method validations
- Self-motivated and ability to work as part of a team with good project management skills
- High level written and verbal communications with advanced PC skills
- Knowledge and experience of operating in a development and commercial lab environment
- Project management or qualifications such as Project Management Professional (PMP)
Desired Qualifications/Experience:
- Knowledge of and experience in applying Six Sigma and Lean methodologies
- Equipment commissioning and qualification.