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QC Scientist, Technology

Genentech

This is a Full-time position in Hillsboro, WV posted March 15, 2021.

nnJob Summary:nn nnGlobal Quality Control Technology Innovation Implementation is looking for a motivated scientist to join our team.

The QC Scientist is part of the Global Quality Control (gQC) Technology department and is responsible for development and implementation of analytical microbiological/adventitious agent testing methods, control system/specifications, and analytical innovation in the arena of quality control.

This role will focus on Next Generation Sequencing (NGS) development for QC testing.

This role is responsible for the proper and timely execution of all aspects of biological and biochemical assay development, optimization, validation, and technology implementation to the internal network and partners.

In addition, this role is involved in the development and troubleshooting of new rapid micro methods across Roche.nn nnThe QC Scientist is expected to be a key player in Roche/Genentech’s business process for continuous improvement and innovation to identify, evaluate, and implement novel and viable state-of-the-art technologies for analytical QC testing across the network.nn nnJob Responsibilities:nn nnFunctional/Technical:nn nnDevelop Next Generation Sequencing (NGS) for adventitious virus detection with a focus on experimental design, data analysis, equipment qualification and data integrity requirementsnn nnOwning, managing and implementation of methods for microbiology/adventitious agent testing (AAT) for the PT commercial QC network to establish/maintain an up-to-date, compliant and lean state, assuring network-wide harmonization during launch phase and lifecycle management.nn nnProvide QC-microbiology/AAT related solutions to Site QC to drive continuous improvement, standardization, automation, productivity and agility.  nn nnParticipate and lead QC technology strategy for microbiological and adventitious virus assays for support of Real Time Release Testing.

Experience in molecular and alternative microbiology/AAT methods and technologies, including automation of test methods.

Provide technical subject matter expertise for automation of test methods, method validation, and equipment qualification, including data integrity and GMP requirements.nn nnProvide technical subject matter expertise related to method validations, specifications, and troubleshooting issues including discrepancies/investigations, CAPAs, changes and Health Authority inspections.

Assist with root-cause investigations and provide troubleshooting support for global QC network, partners and all regulatory filingsnn nnLeadership:nn nnTeamwork and communication – contribute to an environment of strong team spirit, timely and effective communications, sense of urgency, high motivationnn nnPlanning/organization – ability to establish programs/plans, achieve support by stakeholders, drive execution and deliver results in a changing environmentnn nnNetwork leadership
– as a leader within the QC operation network, drives network activities, alignment, and decision-making.

Ability to influence within a matrix.nn nnAbility to influence within a matrix structure, facilitates groups across cultures, countries, technical competencies and organizational levels.

Operate effectively even in ambiguity.nn nnJob Requirements/Qualifications:nn nnBachelor’s or Master’s degree in Microbiology, Virology, Molecular Biology or other relevant Life Sciences discipline required, PhD preferred  nn nnA minimum of 7+ years of relevant experience in pharmaceutical/biotech experiencenn nnDemonstrated knowledge and execution of Quality Control operations, including assay validation and cGMP, and processes related to pharmaceutical/biopharmaceutical manufacture.

Strong scientific background in microbiology/virology, experience in the assessment of technical data and scientific information, including method validation and regulatory submissionsnn nnAdvanced theoretical and practical knowledge of NGS sample preparation workflows and applications for adventitious agent testing, including experience of virus protocols, QC processes, and sequencing platforms.

Hands-on experience working with NGS-related laboratory procedures, equipment data integrity, automation is desirable.nn nnExperience conducting compendial sterility/endotoxin-related and rapid microbiology assays, PCR, qPCR, nucleic acid purification and quantitation.

Experience in implementation of microbiology/AAT testing technologies and automation for product release and life cycle management purposes is desirable.nn nnAbility to work both independently and collaboratively with cross-functional project teams to manage multiple concurrent, fast-paced projectsnn nnSupport Genentechs mission of advancing and boldly championing diversity, equity, and inclusion.nn

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