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.
Overview:
A fantastic opportunity has arisen for an Associate 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)
Requirements
Responsibilities:
- Support laboratory operations within the laboratory facility which will include support of equipment qualification (PQ) documentation generation of SOP s Work instructions as well as contributing to lab and process establishment.
- Perform supporting activities for general lab operations Run the business tasks such as EM Facility testing method verifications troubleshooting and execution of laboratory studies were required.
- Review trending and reporting of laboratory data to support generation of batch data 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.
- Manage and ensure routine cleans of laboratory equipment are completed as per site procedures ensure laboratory housekeeping standards are maintained identifying continuous improvement opportunities in laboratory processes.
- Responds to standard requests from partners customers and clients (internal and/or external) and escalate to manager when appropriate
- Active participation in functional meetings facilitation of cross-functional meetings where required audits ( internal and external)
- Support site safety culture.
- Support introduction of novel innovative solutions supporting the testing of biologics within the facility.
- Build team effectiveness skills learn to promote team success through own actions and by demonstrating respect and appreciation for diverse populations.
- Support timely training completion and coaching of team members.
- Be flexible to support changing business needs (e.g. Infrequent out of hours testing support for exceptional circumstances).
Skills & Qualifications:
- A degree qualification in a relevant field (Biological Sciences/ Engineering) preferable for background in microbiology.
- A minimum of 1-3 years experience working in a relevant academic or industry field (Internships and student placements will be considered in lieu of experience).
- Ability to work as part of a team and on own initiative in a constructive manner.
- Some knowledge with Biologics manufacturing and familiarity with microbiological testing techniques.
- Knowledge of laboratory systems (e.g. LIMS E-logs MODA and electronic notebooks).
- Ability to think logically and be proactive under pressure.
- A good knowledge of GMP familiarity with USP EP JP requirements.
Support laboratory operations within the laboratory facility which will include support of equipment qualification (PQ), documentation generation of SOP s, Work instructions as well as contributing to lab and process establishment. Perform supporting activities for general lab operations, Run the business tasks such as EM, Facility testing, method verifications, troubleshooting and execution of laboratory studies were required. Review, trending and reporting of laboratory data, to support generation of batch data, 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.
Education
A degree qualification in a relevant field (Biological Sciences/ Engineering), preferable for background in microbiology. A minimum of 1-3 years experience working in a relevant academic or industry field, (Internships and student placements will be considered in lieu of experience). Ability to work as part of a team and on own initiative in a constructive manner. Some knowledge with Biologics manufacturing and familiarity with microbiological testing techniques. Knowledge of laboratory systems