Analytical Sciences Associate Specialist

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:

The Site Analytical Sciences Associate
Specialist/Specialist role is responsible for supporting Analytical Procedure
Life Cycle through end-to-end method lifecycle management including
introduction of new analytical methods, analytical transfers, SME assessment
for all analytical method & equipment performance qualification,
investigations, product testing and technical rationale. This work will support
pipeline and commercial products by utilizing expertise in the analytical areas
of separations and biochemistry.

Requirements

Key Responsibilities:

Support/Lead analytical method transfers, validations,
and compendial method verifications.

Perform laboratory-based analytical testing and technical
studies using a variety of analytical techniques and instrumentation.

Generate, review, interpret, and verify analytical data
and technical documentation.

Support lifecycle management and continuous improvement
of analytical methods.

Assist with troubleshooting of analytical methods and
laboratory equipment.

Support equipment performance qualification activities
(PQ).

Participate in laboratory investigations, deviations,
CAPAs, and change controls.

Collaborate with Quality Control, Manufacturing,
Validation, Technical Operations, and Global Analytical teams.

Ensure compliance with cGMP, data integrity, safety, and
regulatory requirements.

Supporting digital method development.

Qualifications & Experience:

Education:

• Bachelor's Degree in Analytical Chemistry, Chemistry,
  Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related scientific
  discipline.
  
• Experience:
  
• Minimum 2-5 years' experience within the pharmaceutical,
  biotechnology, or vaccine industry.
  
• Experience working in a GMP-regulated laboratory
  environment.
  
• Experience with analytical testing, data review, and
  technical documentation.
  
• Experience with method validation, method transfer,
  compendial testing, chromatography, electrophoresis, ELISA or analytical
  troubleshooting is advantageous.
  

Desired Technical Skills

• HPLC/UHPLC (Agilent/ Waters)
  
• CE-SDS (AB Sciex instruments)
  
• icIEF (Maurice, Biotechne)
  
• Empower Software Competency
  
• Solo VPE
  
• ELISA
  
• Cell Based Assay
  
• Compendial testing and Method Verifications
  
• Data analysis and technical report writing
  
• Laboratory investigations and root cause analysis
  
• GMP documentation and data integrity practices
  

What We Are Looking For

• Strong analytical and problem-solving skills.
  
• Excellent attention to detail and commitment to quality.
  
• Effective communication and teamwork skills.
  
• Ability to manage multiple priorities in a fast-paced
  environment.
  
• A proactive approach to learning, innovation, and
  continuous improvement.