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 Analytical
Associate Scientist R&D 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 an onsite & day based role
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 and ways of working.
* 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 Required:
o A degree qualification in a relevant field (Biological
Sciences/ Engineering), preferable for background in microbiology.
o A minimum of 1+ years experience working in a relevant
academic or industry field, (Internships and student placements will be
considered in lieu of experience).
o Ability to work as part of a team and on own initiative
in a constructive manner.
o Some knowledge with Biologics manufacturing and
familiarity with microbiological testing techniques.
o Knowledge of laboratory systems (e.g. LIMS, E -logs, MODA,
and electronic notebooks).
o Ability to think logically and be proactive under
pressure.
o A good knowledge of GMP, familiarity with USP, EP, JP
requirements.