Biologics ytical Scientist
Biologics ytical Scientist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
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 cloudbased 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 likeminded 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 diversecultural work setting.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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 ytical Research & Development department is seeking applicants for a Scientist position which is a laboratorybased scientific role tasked with ytical testing of drug substance for release ility and characterization of biologic products under GMP/GDP and ytical od validations/transfers. The successful candidate must function well and be able to collaborate in a fastpaced integrated multidisciplinary team environment.
Main areas of responsibility include:
of ytical od validations and transfers and write technical protocols and report
of ytical testing of drug substance release ility and characterization for biologics under GMP/GDP
Preparation of ytical ods SOPs and other doents as required
Other ytical activities in consultation with the Supervisor
Works in accordance with applicable internal company regulations: safety health and environmental protection.
Train new ysts
Requirements
Required Education:
M.S in ytical chemistry/biochemistry or related field or B. S with a minimum of 3 years of experience in the Pharmaceutical Industry.
Required Experience and Ss:
Strong oral and written communication ss
Ability to work in a team environment with crossfunctional interactions is essential
GMP working experience
Requirements
and review of ytical od validations and transfers (among different sites and between the company and CROs)
and review of ytical testing of drug substance release ility od qualification incoming goods ID testing and characterisation for biologics under GMP/GDP.
Crosstrain Scientists within the department for new and existing technologies.
Ability to organise and elish 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 essments and change records as required.
Preparation of ytical ods SOPs and other doents as required
Preferred experience and ss:
Author technical protocols and reports as required
yse and optimise current lab/business processes in the laboratories and support implementation activities of the technologies and odologies
Required Experience and Ss: Experience with ytical 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 ss Ability to work in a team environment with cross-functional interactions is essential GMP working experience Perform supporting activities for general lab operations, training, new product introduction, od verifications and od transfers. and review of ytical od validations and transfers (among different sites, and between the company and CROs) and review of ytical testing of drug substance release, ility, od 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 elish 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 essments, and change records as required. Preparation of ytical ods, SOPs and other doents as required
Employment Type
Full Time
