ClinicalScientific

Education:         

    BS or equivalent in relevant discipline with a minimum of 4 years of relevant industry experience or Masters degree in relevant discipline with a minimum of 1 year of relevant industry experience

  Experience in pharmaceutical industry with a GMP testing focus ideally covering the analytical method and testing lifecycle from development through commercial drug product testing with experience in a GMP QC release testing role

    Experience in developing methods with particular emphasis on cell-based potency assay molecular biology assay and protein chemistry assays

    Significant experience in an FDA-regulated environment

    Entrepreneurial spirit with strong willingness to take on new challenges required to bring novel medicines to the clinic

    Excellent organizational and communication skills

    Experience with JMP statistical software a plus.

Representative responsibilities will include but not necessarily be limited to the following:

Collaborate with research analytical development and process development teams to develop qualify/validate AAV gene therapy protein chemistry assays and molecular biology assays for process monitoring and drug product release such as HPLC ELISA CE-SDS western immunoassay droplet digital PCR or qPCR culture of primary mammalian cells and cellbased potency assays.

    Collaborate with research analytical and process development teams to determine critical quality attributes (CQAs) monitor process and method performance and troubleshoot

    Develop timelines protocols and reports for assay transfers qualifications / validations.

    Contribute to establishing material specifications for drug substance and drug products

    Author and review QC analytical SOPs protocols and reports

    Ensure the timely execution of all routine QC testing data review and preparation of summary reports

    Perform quality management activities such as deviation CAPA change control investigation of OOS OOT and anomalous results within the company QMS according to established procedures.

    Maintain QC laboratory track critical reagents and equipment logbooks and ensure all the equipment is calibrated

    Software Use Expectations:

        Utilize the LIMS system to submit samples enter data and track samples.

        Utilize statistical analysis software to generate assay control charts and recommend assay acceptance criteria.

        Learn and become proficient in all laboratory instrument software to conduct testing.

Skills:   

Insmed is seeking a QC Scientist with broad knowledge and expertise in chemical/biochemical assays and molecular biology assays as applied to AAV gene therapy products. The QC Scientist will be involved method development and/or method transfer. The QC Scientist will author and execute phase appropriate qualification/validation protocols and reports of QC methods to support product release and stability. The role will perform analysis on characterization lot release and stability samples for clinical phase Insmed AAV Gene Therapy products.

Regards

Mohammed ilyas

PH - or text - or you can share the updated resume at com

Additional Information :

All your information will be kept confidential according to EEO guidelines.

Remote Work :

No

Employment Type :

Contract