QC Chemist III
Posted on May 25, 2021 by Elevate Direct
QC Chemist III
This QC Chemist III role requires significant expertise/specialisation in analytics for Solid Oral Dosage and Biological Product Portfolios. It is responsible for analytical operations including Analytical Method Transfers, New Product Introductions, process & cleaning optimisations, technical investigations, and quality control testing to support our GMP operations.
Technical leadership of Analytical Method Validation/Transfers for Solid Oral Dosage & for Biological Products as appropriate.
Execution of process and cleaning validation studies in support of New Product Introductions.
Provision of technical support to Operations for investigations and optimisation projects.
Deliver new technologies and continuous improvement initiatives to meet business requirements.
Lead QC TS investigations/troubleshooting and technical projects within the function.
Support the procurement and qualification of new equipment for new product technology transfers.
Demonstrates skills in data analysis (ex: UPLC, HPLC, CE,) and ability to critically evaluate data quality.
Proficiently executes biological laboratory techniques such as liquid chromatography, capillary electrophoresis (CE), and other separation techniques commonly used for biologics such as size-exclusion (SE) etc as well as Bioassays with experience in performing Cell Binding and Cell Cytotoxicity Assays
Review's data and results of testing to ensure compliance to appropriate specifications and protocols.
Writes and executes protocols and reports.
Assists in the training of QC staff.
Writes and revises methods, specifications, and SOPs as needed.
May develop methods for performing cleaning validations.
Demonstrates and applies an advanced level of understanding of project goals and methods.
Executes analysis efficiently, consistently, and with high quality and suggests improvements.
Acts as a resource for other employees within the department.
Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
Experience in test methods for Solid Oral Dosage, biologic, and biopharmaceutical products.
Strong knowledge and understanding of cGMP, quality control (QC), and regulatory requirements for GMP laboratories in pharmaceutical industry.
Advanced knowledge of current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (GMPs).
Hands-on experience with equipment qualification and analytical techniques such as UPLC/HPLC, CE, SE and potency assay is an advantage.
Knowledge of software such as Empower and LIMS.
Critical thinking skills and ability to solve moderately complex problems and good judgement in making recommendations.
Significant years of relevant experience with BA or BSc degree in Chemistry, Biopharmaceutical Science or equivalent.
Prior experience in a biologic testing laboratory a distinct advantage.
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