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Description: 1year contract with possible renewal.
QC Analyst 2 will contribute to the success of the operation by providing accurate, GxP-compliant analyses of clinical biopharmaceutical products and by participating in assay qualification and validation studies. Biopharmaceutical manufacturing runs typically cost in excess of 1$ million each and reach many times that for larger, phase 3 campaigns, while stability studies cost several hundred thousand dollars each, and this individual has an important role in ensuring that release and stability testing generates accurate results, without delays or compliance issues. The individual will help maintain the biochemistry laboratory systems, assist in training other analysts, help maintain SOPs and other documents, and promote an orderly and efficient laboratory workplace.
Education: BS in biological or chemical sciences or equivalent
• Minimum of 2-4 yrs working experience in a cGMP Quality Control, analytical development, analytical transfer or validation department in a FDA-regulated industry.
• Knowledge of principles, concepts, and practices in QC testing of protein biopharmaceuticals.
• Hands-on experience with at least two techniques, such as HPLC, capillary electrophoresis, ELISA, or SDS-PAGE, used for analysis of recombinant proteins.
• Knowledge of GxP requirements and ICH/FDA/EMA guidelines.
• Ability to identify and help investigate assay and equipment problems.
• Fluent in English, good written communication skills; good interpersonal skills.
• Team player who can excel in a “hands-on” entrepreneurial environment.
• Physical requirements: handling of laboratory equipment, chemicals, and biological materials.
Eisai requires all contractors providing services to Eisai to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date to their employer/supplier, to the extent permitted under applicable law. This requirement is a condition of providing services to Eisai, and it applies regardless of whether the contractor is located at an Eisai site, field based or is fully remote. If you are unable to receive the vaccine for qualified medical reasons (including pregnancy-related) or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation from your employer/supplier.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.