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 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.
Requirements Responsibilities: Support laboratory operations within the new 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.
Review, trending and reporting of laboratory data, to support generation of batch data, maintain oversight of review metrics, to collate and analyze 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).
Active participation in functional meetings, facilitation of cross-functional meetings where required.
Participation in laboratory investigations and Root Cause Analysis activities.
Participation in internal and external audit and inspection activities.
Participation in SME development groups to improve technical expertise.
Support site safety culture.
Perform supporting activities for general lab operations, EM, Facility testing, method transfers, method verifications, and execution of laboratory studies were required.
A good knowledge of GMP, familiarity with USP, EP, JP requirements.
Support introduction of novel, innovative solutions, supporting the testing of biologics within the facility.
Participation in risk assessments as required.
Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
Excellent troubleshooting and problem-solving skills as an individual contributor as well as collaboration skills and teamworking ability with global and interdisciplinary teams.
Support Culture of the client ways of Working.
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).
Act as a group representative at cross-functional meetings.
Experience, Knowledge & Skills: Ability to work as part of a team and on own initiative in a constructive manner.
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.
Effective communicator and technical expertise in science, to be able to share and communicate that knowledge through training other analysts.
To support site culture Qualification: 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).
#LI-AM1 Requirements 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).