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Bachelor's degree in Chemistry, Biology or Biochemistry, with 5 years pharmaceutical/biopharmaceutical experience
Has knowledge of GxP requirements, and thorough knowledge of US, EU, WHO & ICH regulatory requirements
Candidate must have a strong working knowledge in a pharmaceutical or biopharmaceutical Quality Control or development laboratory environment with experience in associated analytical methods (eg SDS-PAGE, ELISA, cIEF, SEC, CEX-HPLC, Immunoassay and Bioassay)
Experience with word processing and database software (i.e. Microsoft Word and EXCEL) is necessary.
Ability to work flexible hours to support business needs.
Excellent communication skill, ability to interact with both internal and external parties
Ability to work both independently and within a team environment
RESPONSIBILITIES OF JOB:
This individual will be responsible for ensuring the Quality Control testing are performed in according with cGMP for assigned BioPharms projects. The individual will responsible to ensuring the evaluation, analysis and documentation of test data in the appropriate Quality Systems utilized in BioPharm R&D. Remit will also include performing assay qualification against pre-defined protocol, gathering and analyzing data, performing critical evaluations up to and including consolidating data for final analytical tech transfer report. The individual will also be responsible for ensuring the relevant quality infrastructure such as reagent and sample inventory are maintained and laboratory equipements are maintained against their defined schedule. This position does not have any direct reports.
SPECIFIC DUTIES OF THE ROLE/POSITION:
Provides bioanalytical support for biopharmaceutical products produced within the Biopharm R&D
Responsible for running cGMP samples on biochemical assays such as HPLC, SDS-PAGE, ELISA, and Total Protein Assays for release and in-process testing.
Responsible for participating in assay qualification and tech transfer.
Responsible for following standard operating procedures to maintain cGMP compliance.
Responsible for maintaining laboratory equipment and facilities.
Responsible for calibration of laboratory instrumentation.
Participates in the investigating of OOS and atypical results obtained during cGMP analytical testing.
Drafts or revises analytical methods or SOPs in a cGMP documentation system.
Participates in preparation for internal and quality group audits.
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