Senior Scientist, Analytical Development
ProClinical, in support of our client, are seeking an individual to fill the role of Senior Scientist, Analytical Development and QC, based in Birmingham, AL. The successful candidate will perform and oversee analytical testing of relevant materials according to written SOPs and test methods.
- Prepare of mobile phases, standards, samples, and other laboratory solutions.
- Operate, calibrate and maintain instruments and equipment according to SOPs.
- Calculate, evaluate, interpret and document data results. Report abnormalities to all relevant parties/individuals.
- Trend stability data and shelf-life experience.
- Write and review SOPs and test methods.
- Assist in projects with contract manufacturing organizations.
- Oversee the analytical progress during the manufacturing campaign.
- Maintain personal training record.
- Assure all aspects of method development, validation, troubleshooting and laboratory compliance procedures follow regulatory guidelines.
- Contribute towards the submission and approval of drug application dossiers, including an NDA
- Review and may evaluate other chemists' data and results.
- Develop and validates analytical methods; coordinated methods and technical transfers
- Manage a heavy workload with multiple priorities.
- Evaluate, interpret, and communicate analytical data.
- Track down impurities and identifies them by spectroscopy techniques
Skills And Qualifications
- BA/MA in a scientific discipline (chemistry preferred) and 5-15+ years of lab experience.
- Knowledge of and ability to perform analytical SOPs and test methods of varying complexities.
- Excellent knowledge of appropriate regulations (cGMP/GLP).
- Able to work with minimal supervision.
- Details oriented with meticulous oversight.
- Excellent written, verbal, and interpersonal communication skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Hunter Tonn at (+1) 646-851-0086 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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