About PSC BiotechWho we are?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 PropositionEmployees 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. The Laboratory Analyst has responsibility for Raw
Material, Intermediate and Drug Substance testing to meet compliance
requirements and customer targets. The Analyst may also take a leadership role
in change or improvement projects at site level.RequirementsThe Laboratory Analyst is responsible for ensuring all
testing activities comply with cGMP. The Laboratory Analyst assures compliance
with all safety and environmental requirements. Compliance with other regulated
areas such as HR policies are also responsibilities of the role.To test Raw Materials, Intermediates, Drug Substance,
Drug products in accordance with Quality Standard and/or other approved
protocols.To comply with all GMP and analytical procedures relevant
to area of work.To adhere and comply with department High Performance
Analytical BehavioursTo document all testing activities and to input results
into computerised lab systems in accordance with department and our
Manufacturing Division standards.To provide analytical support to product quality
investigations and new product demonstrations under the supervision of the
Laboratory Leader or designate.Complete the investigation of laboratory OOSs in line
with site and divisional procedures.Complete documentation checks (e.g. PCR’s, ACRs,
Deviations) as required for the Drug Substance/Drug Product test package prior
to release.To complete testing as required on samples to support
process changes.Accountable for own laboratory safety practices.To provide lead analytical support to product quality
investigations and new product demonstrations using own initiative and with
minimum supervision.Provide leadership in the laboratory aspects of OOS
investigations.To identify and aid resolution of analytical issues
within the IPT laboratory.To be a resource for analytical testing for the site as
required.Execute specific assignments (e.g. stability programme,
instrument management and other systems) in a comprehensive manner and under
minimum supervision.Experience, Knowledge & Skills:Have knowledge of GMP standardsHave knowledge Laboratory safety standards.Must have good communication skills, both written and
verbal.Strong documentation skills are required.Must be motivated, focused and technically strong.To perform analytical testing with a high degree of
precision and accuracyTo perform instrument maintenance and troubleshootingTo maintain accurate records in compliance with GMP
expectationsTo understand and internalise procedures relevant to GMP
operations.To communicate clearly and concisely on technical issuesOn assignment, to deliver project goals on time.Analytical chemistry – demonstrated ability in all
technical elements relevant to ADC IPT operation.Technical lab skills (precision, etc)Communication - written, oralTeam and interpersonal skillsLeadership skills Qualifications & Education:Minimum of BSc in Chemistry or related discipline #LI-PM3