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 and exciting opportunity has arisen for an
Analytical Scientist, 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 (primarily extended days but
it is subject to business needs).
Requirements
Responsibilities:
* 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 by
* Be 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 Required:
o A degree qualification in a relevant field (Biological
Sciences/ Engineering), preferable for background in microbiology, An Advanced
Degree (e.g., MSc) qualification is desirable.
o A 3+ years experience working in a relevant industry field.
o Ability to work as part of a team and on own initiative
in a constructive manner.
o Technical Knowledge with Biologics drug substance
manufacturing and microbiological testing techniques.
o Ability to think logically and be proactive under
pressure.
o Effective communicator.