Christian Schell Email & Phone Number

Harrisburg, Nc, Us

Research Triangle Park, North Carolina, Us

Ann Arbor, Michigan, Us

Quality lead for Drug Product disposition and CMO oversight of Oral Solid Dosage Finished GoodsQuality lead for Annual Product Quality Review of two Marketed ProductsQuality lead support for Notification to Management and Market Action activities

Mumbai, Maharashtra, In

Quality lead for on-site manufacturing disciplines (Oral Solid Dosage, Sterile Injectables and Nebulizer), including in-process quality oversight and batch disposition/release functions Quality lead for quality event management system incorporating change control, deviations, incidents and CAPA, as well as document control oversight of GMP documentation including SOPs and Batch Production RecordsSite co-leader for regulatory inspections and management review/quality council activities

Malvern, Pa, Us

GMP Compliance Officer and direct liaison to FDA for post-marketing surveillance activities, including Field Alert Report submissions, Market Action / Product Recall communications and counterfeit / diversion notifications, as well as on-site lead for FDA Preparedness / InspectionsQuality Operations lead responsible for management of two Quality Managers and oversight of sterile solid dosage (implantable pellet) manufacturing facility, including final Quality approval:- Change Control- Manufacturing and Product Complaint Investigations- Corrective Action / Preventive Action (CAPA)- Qualification / Validation Activities- Quality Agreements for CMOs and CTLs- FDA Preparedness / Inspections- Annual Product Review- Management Review

Malvern, Pa, Us

Manage corporate Audit Program and Audit Team for branded products; responsible for External and Internal Audits of contract manufacturers, suppliers, vendors, and departments associated with the company’s commercial, generic, and research & development programsSchedule, coordinate, and execute assigned External and Internal AuditsCreate agendas, author final reports, and perform necessitated follow-up and CAPA remediationAssist Senior Director of Quality & Compliance with oversight of Supplier Qualification and Risk Management, post marketing surveillance including Field Alerts, Market Withdrawals and Product Recalls, Compliance Metrics, and Regulatory body (e.g., FDA) inspection readiness and execution (front room Scribe and Host back up)

Us

QA representative responsible for clinical supplies manufactured at the Chemical Synthesis Center (CSC) and clinical supplies manufactured/labeled/packaged in Technical Operations Building 500Executed lead QA functions for assigned Phase I through Phase III clinical trial materials, including Drug Substance (API), Drug Product (capsules, tablets and lyophilized vials) and primary-packaged Drug Product for labeling and stability purposesReviewed draft and completed Batch Records for final disposition of GMP clinical suppliesPerformed QA support function of electronic management systems (TrackWise, QDocs, ComplianceWire, Maximo, and Clinicopia)Performed QA support function for CMC cross-functional teamsPerformed QA man-in-the-plant function for contract manufacturing operationsPerformed contract manufacturer, supplier and internal auditsCo-authored site SOPs for performing Investigations and Internal Self-Inspections

Us

Quality oversight and direct contact for corporate QA at Chemical Synthesis Center (CSC)Managed site SOP, Training, Change Control, and Investigation systemsManaged material approval and Batch Record system for processes in the Kilo Lab and Pilot PlantTrained CSC and Facilities staff on site SOPsReviewed draft and completed Batch Records for GMP processesReviewed contractor Validation documents, oversaw document approval process, and maintained retention files for site Commissioning and Qualification activitiesCSC representative for QDocs, ComplianceWire and Maximo implementation activitiesMember of Corporate Policies and Procedures CommitteeDeveloped and project-managed site SOP, Training, Change Control, and Investigation systemsHosted corporate Internal Audit to achieve site GMP-status for Kilo Labs and Pilot PlantManaged CAPA completion process in response to corporate Internal Audit

New York, New York, Us

Developed cross-functional skills and experience through rapid career advancement from manufacturing production record reviewer and supervisor to key player in ensuring quality assurance compliance throughout the facilityVarious positions in manufacturing and quality assurance, ranging from record reviewer to supervisor Experience in sterilization, lyophilization, and aseptic filling operations, along with quality systems including procedures, investigations, change control, and training

New York, New York, Us

Start-up facility in Grange Castle, Ireland; facilitated Change Control subcommittee in Drug Substance Operations, which included leadership role of committee meetings and processing of Change Controls in electronic management system (TrackWise); processing included QA2 and QA3 functions for routing and closure

New York, New York, Us

Investigated manufacturing, environmental, and quality control discrepancies including identifying root causes, determining corrective actions, assessing impact on products or processes and recommending disposition; wrote clear, concise summaries of investigations; participated on Cross-Functional Review team to resolve MIR issuesParticipated on Vaccine Development Compliance Council and Clinical Complaint TeamDeveloped and reported R&D and CAIV monthly metrics for MIRs, LIRs, CMTsCoordinated Overdue Investigations Team and successfully reduced greater than 60-day investigations from mid 50's to single digits in six-month time period

New York, New York, Us

Supervised approximately 20 personnel in departmental operations including development, revision, circulation, publication and distribution of all site Level III DocumentsSuccessfully implemented revised system in response to Corporate Guidelines and Consent Decree remediation, including training of approximately 1500 employees for departmental SOP compliance, control and use of Level III Documents, and control and maintenance of site SOP/CPI ManualsAssisted Unit Manager with implementation and verification of process changes for 12 Consent Decree commitments; participated in remediation process for closure of subject commitmentsDeveloped and presented Procedures Unit monthly metrics to Quality Council; recognized by Senior Director of QA for excellence in departmental improvement and quality of presentations

New York, New York, Us

Facilitated revision, circulation, publication and distribution process of all site SOPs/CPIs as per departmental SOPs; updated Unit Training Manual, assured training compliance for all departmental personnel, and developed Lesson Plans for all departmental SOPs

New York, New York, Us

During subject timeframe, supervised 1st, 2nd and 3rd shift operations in Labware Preparation and Sterilization, Media and Solution Formulation, Filter Preparation and Testing, Component Sterilization, Lyophilization, and Vial FillingPerformed supervisory review of various types of records related to sterilization of equipment, formulation of media and solutions, preparation of filters, and aseptic preparation (filling, lyophilization, and capping) of parenteral productsAcquired skills in aseptic processing and sampling techniques in Class 100 and 10,000 areas, operation of steam sterilizers and hot air ovens, tunnel washers, and vial filling equipment related to filling, stoppering and capping of filled product

New York, New York, Us

Reviewed documentation pertaining to various production tasks in Labware Preparation and Sterilization, and progressed to supervising department operations on 2nd/3rd shift during Influenza production periods

Drug Development Certificate, Qa/Ra Program

B.S, Biology