Ben Ruby Email & Phone Number

Temecula, Ca, Us

Temecula, Ca, Us

San Diego, California, Us

Basel, Baselstadt, Ch

(Formerly AveXis)Managed, recruited, and set target priorities for QA for QC department and employeesProvided support, guidance, mentorship, development, and training to QA for QC departmentManaged backroom and presented as QA subject matter expert during FDA inspection and auditsReviewed and approved release and stability data, technical reports, development testing protocols, method validation, method transfer, and equipment qualification dataMet key department performance targets, including 100% on-time test approvalReviewed and approved deviation, OOS, CAPA, EC, and change control records Created, updated, reviewed, and approved SOPs and formsReviewed and approved equipment and system qualification documentationProvided guidance and acted as point of contact for quality issues for QC personnelPerformed risk assessments for equipment and electronic systems

Somerset, Nj, Us

(Formerly Pharmatek)Supervised one entry level QA associate in day-to-day job functionsReviewed and approved release and stability data, certificates of analysis, development and validation reports, analytical testing protocols, test methods, and specificationsReviewed and approved Investigations (Out of Specification), Deviation, and Change Control documentationCreated, reviewed, and approved SOPs and formsImplemented TrackWise modules for Supplier Management and Laboratory InvestigationsPerformed routine internal audits of quality systems and analytical laboratoriesPerformed external audits of laboratory service vendors and suppliersHosted on-site client auditsSupported GMP manufacturing activities, including: release of GMP raw materials, performance of line clearances in Class 100,000 clean rooms, label reconciliation, and quarantine and release of final productParticipated in regular cross-departmental meetings to discuss quality issuesReviewed and approved stability schedule and reference standard documentation

Reviewed synthesis and purification batch records, along with QC release packetsInitiated, managed, investigated and closed deviationsPerformed internal audits of quality systemsWorked on change controls, out of tolerances, opportunities for improvement, CAPAsOversaw the equipment calibration and maintenance program, along with equipment qualificationProvided initial hire training and reviewed training recordsPerformed line clearances for synthesis and purification in a clean room environment (Class 10k / 100k or ISO 7 / 8)Performed final product inspection on finished API and shipping verificationExperienced in document control and record managementExperienced with paper based systems and electronic documentation systems (Ragic)

Worked in the synthesis department of the manufacturing groupSynthesized and deprotected peptidesPerformed in-process HPLC analysis of crude peptideManufactured peptides that were anywhere from ~10 - 45 amino acids in length

La Jolla, Ca, Us

Instructed upper division organic chemistry laboratory classes for a total of 4 quartersHelped students learn organic chemistry and the related lab techniquesHelped students develop safe lab practicesAdministered quizzesGraded all of their coursework, lab work, and tests

Master Of Science (Ms), Chemistry

Bachelor Of Science (Bs), Biochemistry/Chemistry