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 PropositionEmployees 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:A fantastic opportunity has arisen for an Analytical Scientist R&D in our Dunboyne facility.
This individual will work closely with the Enabling Technology and Engineering group to leverage Process Automation knowledge as well as the Analytical group to enable the adoption of Process Analytical Technology (PAT).
The Microbiology Lab Operations group with work closely with Operations to understand facility fit and will be able to flex resources as needed.
This is a shift-based role (4 day on / 4 day off, 7 day rolling shift on extended days only (7am to 7pm)RequirementsResponsibilities:Drive laboratory operations within the new laboratory facility which will include oversight of equipment qualification (PQ), documentation generation and SME review of SOP's, Work instructions as well as contributing to lab and process establishment.Review and/or lead, trending and reporting of laboratory data, to support batch release, maintain oversight of review metrics, to collate and analyse end of quarter and year reports for all raw data generated.Maintaining and release of laboratory stock, ordering laboratory consumables where required.Active participation in functional meetings, leading of departmental and cross-functional meetings where required.Participation in internal and external audit and inspection activities and ensure permanent inspection readiness.Support and drive site safety & ways of working culture demonstrating respect and appreciation for diverse populations..Perform supporting GMP activities & troubleshooting for general lab operations, EM, Facility testing as required, and execute in-process and drug substance analysis studies & lead/ participate in laboratory projects.Support introduction of novel, innovative solutions, collaborating with the global Microbiology Center of Expertise and participating in lean lab methodologies.Ability to organise and establish testing schedules and adhere to deadlines.Build team effectiveness skills, learn to promote team success through own actions and byBe flexible to support changing business needs, (e.g.
Infrequent out of hours testing support for exceptional circumstances).Be able to share and communicate that knowledge through training other analysts & maintain timely training completion Skills & Qualifications:A degree qualification in a relevant field (Biological Sciences/ Engineering), preferable for background in microbiology, An Advanced Degree (e.g., MSc) qualification is desirable.A 3+ years experience working in a relevant industry field.Ability to work as part of a team and on own initiative in a constructive manner.Technical Knowledge with Biologics drug substance manufacturing and microbiological testing techniques.Ability to think logically and be proactive under pressure.Effective communicator.