Biologics Analytical Scientist

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.

The Biologics Analytical Research & Development department is seeking applicants for a Scientist position which is a laboratory-based scientific role tasked with analytical testing of drug substance for release, stability and characterization of biologic products under GMP/GDP and analytical method validations/transfers.  The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.

 

Main areas of responsibility include:

·       Execution of analytical method validations and transfers  and write technical protocols and report

·       Execution of analytical testing of drug substance release, stability and characterization for biologics under GMP/GDP

·        Support equipment maintenance, calibration and qualification work
·       Preparation of analytical methods, SOPs and other documents as required
·      Other analytical activities in consultation with the Supervisor
·       Works in accordance with applicable internal company regulations: safety, health and environmental protection.
Train new analysts

Requirements

Required Education:

·       M.S in analytical chemistry/biochemistry or related field or B. S with a minimum of 3 years of experience in the Pharmaceutical Industry.

Required Experience and Skills:

·       Experience with analytical testing with Ultrahigh Pressure Liquid Chromatography (UPLC)/High Performance Liquid Chromatography (HPLC), Capillary Electrophoresis, or other large molecule characterization technique
·       Strong oral and written communication skills
·       Ability to work in a team environment with cross-functional interactions is essential
·       GMP working experience

Requirements

  Perform supporting activities for general lab operations, training, new product introduction, method verifications and method transfers.
·       Execution and review of analytical method validations and transfers (among different sites, and between the company and CROs)
·       Execution and review of analytical testing of drug substance release, stability, method qualification, incoming goods, ID testing, and characterisation for biologics under GMP/GDP.
·       Cross-train Scientists within the department for new and existing technologies.
·       Ability to organise and establish testing schedules and adhere to deadlines.
·       Support equipment maintenance, calibration and qualification work
·       Perform periodic review of instrument systems
·       Generate instrument data in support of SDLC Validation.
·       Initiate, review, and support deviations, CAPAs, and, risk assessments, and change records as required.  
·       Preparation of analytical methods, SOPs and other documents as required

 

Preferred experience and skills:

Understanding of current manufacturing processes
·       Author technical protocols and reports as required
·       Analyse and optimise current lab/business processes in the laboratories and support implementation activities of the technologies and methodologies

 

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