Job ID:
Job date: 2017-05-23
End Date:
Company : Sangamo Therapeutics Country : Role : Research Scientist
Job date: 2017-05-23
End Date:
Company : Sangamo Therapeutics Country : Role : Research Scientist
Job Description:
The Analytical Methods Technical scientist will be responsible for transitioning NGS-based research assays into the Quality Control group. These assays will require the validation of in-house developed software and may require programing in order to implement a report format appropriate to the Quality Control environment. Essential functions: -Oversee the transition of NGS-based assays into the Quality Control group. -Drafting and review of SOPs, forms, test records and protocols to facilitate transfer of methods to in-house QC -Transfer of methods and training of staff within the in-house QC department -Assist in the preparation of CMC regulatory submissions -Other activities as may be assigned Education, Experience and skills requirements: The ideal candidate for this position will have demonstrated in-depth experience of the development, qualification, and validation of software packages employed for the release testing and stability testing of biologic products in an industry setting. Candidate must possess: -A minimum Bachelor (advanced degree preferred) in Biological Sciences, Bioengineering, Bioinformatics, or Computer Sciences. -A minimum of three years of experience in the biotechnology or pharma industry with a primary focus on Bioinformatics of large genomic datasets. -Experience of the regulatory/pharmacopeia requirements (e.g 21 CFR part 11) for validating software -Proficiency in Python programming language Other requirements: -Experience with NGS-based assays -Sound understanding and demonstrated application of statistical methods/tools -Knowledge of FDA, EMA, GMP, WHO and ICH regulatory requirements -Excellent interpersonal skills -Outstanding organizational skills -Excellent written and oral communication skills The above reflects management’s definition of essential functions for this position, but does not restrict the tasks that may be assigned.The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time.
Additional Info:
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The Analytical Methods Technical scientist will be responsible for transitioning NGS-based research assays into the Quality Control group. These assays will require the validation of in-house developed software and may require programing in order to implement a report format appropriate to the Quality Control environment. Essential functions: -Oversee the transition of NGS-based assays into the Quality Control group. -Drafting and review of SOPs, forms, test records and protocols to facilitate transfer of methods to in-house QC -Transfer of methods and training of staff within the in-house QC department -Assist in the preparation of CMC regulatory submissions -Other activities as may be assigned Education, Experience and skills requirements: The ideal candidate for this position will have demonstrated in-depth experience of the development, qualification, and validation of software packages employed for the release testing and stability testing of biologic products in an industry setting. Candidate must possess: -A minimum Bachelor (advanced degree preferred) in Biological Sciences, Bioengineering, Bioinformatics, or Computer Sciences. -A minimum of three years of experience in the biotechnology or pharma industry with a primary focus on Bioinformatics of large genomic datasets. -Experience of the regulatory/pharmacopeia requirements (e.g 21 CFR part 11) for validating software -Proficiency in Python programming language Other requirements: -Experience with NGS-based assays -Sound understanding and demonstrated application of statistical methods/tools -Knowledge of FDA, EMA, GMP, WHO and ICH regulatory requirements -Excellent interpersonal skills -Outstanding organizational skills -Excellent written and oral communication skills The above reflects management’s definition of essential functions for this position, but does not restrict the tasks that may be assigned.The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time.
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Additional Info:
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