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.
We serve 350 clients in more than 23 countries worldwide, providing cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services.
'Take your Career to a new Level'
PSC Biotech disrupts the conventional consultancy model by offering a unique Employee Value Proposition, including the opportunity to work with talented professionals in the Pharma/Biotech Industry.
We provide permanent employment contracts, exposing employees to top pharmaceutical client sites in diverse cultural settings.
Employee Value Proposition
Employees are the "heartbeat" of PSC Biotech.
We offer empowering career development through in-house training, mentorship, and continuous guidance to facilitate career progression.
We aim to create high-performing teams that exceed client expectations in quality, stay within budget, and meet deadlines.
Overview:
We have a fantastic opportunity for an Analytical Scientist R&D at our Dunboyne facility.
This role involves working closely with the Enabling Technology and Engineering group to leverage Process Automation knowledge and with the Analytical group to adopt Process Analytical Technology (PAT).
The Microbiology Lab Operations team will collaborate with Operations to understand facility fit and flex resources as needed.
This is a shift-based role (4 days on / 4 days off, 7-day rolling shift from 7 am to 7 pm)
Responsibilities:
Drive laboratory operations, including equipment qualification (PQ), documentation, and SME review of SOPs and work instructions.
Review and lead trending and reporting of laboratory data to support batch release, overseeing review metrics, and analyzing end-of-quarter and year reports.
Maintain and manage laboratory stock and order consumables.
Participate in functional, departmental, and cross-functional meetings.
Support internal and external audits and inspections, ensuring inspection readiness.
Promote site safety and a collaborative ways-of-working culture.
Support GMP activities, troubleshooting, and execute in-process and drug substance analysis studies.
Collaborate on the introduction of innovative solutions with the global Microbiology Center of Expertise and participate in lean lab initiatives.
Organize testing schedules and meet deadlines.
Foster team effectiveness and promote success through actions and training.
Support changing business needs, including occasional out-of-hours testing.
Skills & Qualifications:
Bachelor's degree in Biological Sciences, Engineering, or related field; MSc preferred.
Minimum 3 years of relevant industry experience.
Ability to work collaboratively and independently.
Technical knowledge of biologics drug substance manufacturing and microbiological testing.
Logical thinking and proactive under pressure.
Effective communication skills.
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