Thomas M. Schear, B.Sc.

** ******** ******* ******: 908-***-****

Branchville, NJ 07826 Email: acgaob@r.postjobfree.com

Pharma Quality Management / Quality Control Leader

A competent, results oriented leader with over 20 years of Pharma experience with increasing

responsibility within quality, technical and research operations spanning quality management, quality

control, drug metabolism, preclinical development, analytical R&D and pharmaceutical R&D.

Utilizing strong leadership, technical and scientific, knowledge and skills, I have a consistent track record

of successful, completed right first time, compliance and quality projects and initiatives that have spanned

a diverse base of global customers and organizational cultures. My leadership and management of GMP

laboratory operations have enabled gold standards for compliance, quality and performance to be met

over a continuous 12-year span. My close collaboration with quality assurance and manufacturing

resulted in deep knowledge and experience with quality assurance requirements related to overall

Pharma Quality Operations.

Core Competencies

Leadership, teambuilding and transparent communication

Quality Control and cGMP operations and management

Management of cGMP (FDA/EMA/ICH/PMDA) compliance, inspections, audits and CAPA

Third-party cGMP oversight and issue management

Implementation of and adherence to MCRS/KPI performance metrics

Applied Six-Sigma and LEAN

Project management

Laboratory and production investigations and issue management

Risk assessment and management (FMEA)

Applied statistical analysis

Test Method development, validation and transfer

Theoretical and applied, physical, analytical and bioanalytical chemistry

Technical writing

Professional History

Group Leader – Quality Management / Quality Control Chemistry

January 2002 – August 2012

Hoffmann-La Roche Inc., Nutley NJ

Partnered with a new QC director to implement and sustain world-class compliance and quality processes

and standards within the Roche Nutley organization, subsequent to which, no laboratory related, FDA

483’s were issued over a ten-year span.

Continued to manage all compliance and quality aspects of release, validation, stability and complaint

testing for a wide portfolio of marketed products manufactured at Nutley, Roche affiliates and CMO’s.

Responsible for management review and approval of test data, certificates of analyses, investigation

reports, SOP’s, change control documents, methods and specifications, validation protocols, annual

product reviews, statistical reports and training records. Monitored the budget segment related to

laboratory equipment and supplies to ensure the overall departmental budget remained on target.

Managed up to 10 direct reports and indirectly managed a further group of 18 personnel as part of a team

based approach to Quality operations.

Participated as a subject matter expert (SME) during FDA, EMA, PMDA and other health authority

inspections. Managed and conducted internal self-audits of the laboratories for GMP compliance including

those involved in raw materials, API’s and microbiology. Provided responses to both external and internal

observations and closed out CAPA related to observations.

Continued to author laboratory investigation reports that focused on assignable cause and preventative

actions. Recognized by Roche QA as a subject matter expert in failure analysis. As a result of close

collaboration with QA and science based investigative techniques, first draft investigation reports typically

required little to no revision following QA review. Received positive FDA feedback during inspections

regarding the completeness and quality of the investigation reports.

Worked collaboratively with development engineering, validation engineering, production and QA, locally

and at affiliates and CMO’s, to resolve technical and quality issues for a variety of marketed and

development products. Managed transfer of analytical methods and accompanying change control to

affiliates and CMO’s.

In partnership with the QC Director and other group leaders, transformed the Nutley QC organization into a

clearinghouse for emerging quality and product issues. Nutley QC became globally recognized as a center

of excellence that went beyond routine responsibilities and was adept at resolving complex quality and

product issues.

Proposed, then implemented, the use of an external training contractor to improve overall management

leadership skills and then, analyst team building skills. Subsequently, this allowed for the seamless

formation of a unified, silo-free, “one team approach” to QC operations that required minimal maintenance.

Assisted in development and implementation of key performance indicators (KPI’s) and a management

control and reporting system (MCRS) to track QC compliance, quality and efficiency metrics. Customer

satisfaction levels were routinely greater than 98 percent positive. Tracking improved laboratory throughput

and allowed personnel to take ownership of their assignments.

Working collaboratively with the director and another group leader, devised and implemented a scheduling

tool for QC testing assignments and other laboratory responsibilities. Using electronic access, analysts

were able to see their scheduled assignments at least one week in advance. The ability to level load

sample assignments combined with a first-in first-out sample management strategy resulted in reduced

cycle times, improvement in analyst engagement and increased customer satisfaction.

Core team member for development of enhanced standard operating procedures for GMP data review

including chromatographic and spectroscopic data. Controlled worksheets and a review checklist were

developed and standardized to ensure data integrity, consistency and completion of data review.

Collaborated with an external subject matter expert in chromatographic integration and other group leaders

to develop a best practice chromatographic integration SOP. Participated in training analysts to ensure

consistent and defensible integration practices across the department. FDA review of the SOP and a

variety of sample chromatograms during a general inspection elicited very favorable agency responses.

Partnered with metrology reviewing instrument qualification protocols (IQ/OQ/PQ), and metrology related

SOP’s. Performed management approval on executed protocols. Collaborated with metrology to ensure

and sustain a robust and compliant laboratory instrument validation and maintenance program. Assessed

service agreement costs relative to the departmental budget.

Conducted regularly scheduled group and departmental meetings. Prepared meeting agendas and

PowerPoint slides. Meetings were used as open forums to review performance, address or identify

emerging issues and showcase current quality projects.

Participated as a core team member of an Operational Excellence initiative (OPEX), responsible for

bringing LEAN and six-sigma practices into the Quality and QC environment to raise compliance, quality,

and efficiency to gold standards. The OPEX initiative also drove a significant culture change in which

teamwork, transparency, efficiency and ownership of one’s assignments became a way of life across the

quality and manufacturing organizations.

Served as a core team member for a global risk assessment of marketed products initiative. The failure

mode and effect analysis (FMEA) considered all processes from raw material sourcing through release of

finished product to the market. Proposed and implemented mitigation strategies for issues identified

following FMEA activities.

Completed a six-month GMP recovery assignment at an external API manufacturing and testing site.

Authored and reviewed: SOP’s, retrospective and new laboratory investigations and training material.

Provided leadership while training and mentoring a cross-section of QC and QA personnel. Working

transparently with a global team and third-party auditors (Lachman), successfully closed out an interim

control plan as agreed to with FDA/EMA/PMDA.

Served as the Nutley Chemistry subject matter expert for a key global, pandemic anti-viral. Addressed and

resolved issues involving: unexpected degradation profiles, content variability, extension of shelf-life,

temperature excursions and manufacturing/testing deviations for product manufactured on site, at Roche

affiliates and CMO’s.

Served as the Nutley Chemistry subject matter expert for a key global, immunosuppressant transplant

medication. Addressed and resolved issues involving: blend variability, in-use stability studies, reduced

stability testing, and packaging deviations for product manufactured on site, at Roche affiliates and CMO’s.

Served as a core team member for the development and implementation of a statistically based, release

data trending program for all marketed products. The resulting package consisting of SOP’s, a software

recommendation and computer system validation (CSV) support was rolled out to both Roche affiliates and

contract manufacturing organizations (CMO’s). Traveled to provide on-site training during implementation

at the CMO’s.

Assisted core teams with user requirement specifications, validation and implementation of Atlas,

Empower and TrackWise, bringing these state of the art electronic data acquisition and data management

applications into the QC laboratories.

Performed statistical analysis to support production and laboratory investigations, process validations,

evaluation of stability trends and shelf life dating. Performed statistical analysis for individual projects as

required such as justification for reduced stability testing.

Assisted core teams with CSV assignments as needed. Developed defensible, written procedures to

address Part 11 compliance as applied to legacy software.

Managed interactions and lent technical guidance between affiliates and CMO’s identifying, investigating

and resolving technical, quality and compliance issues.

Authored CMO and affiliate Quality Agreement sections encompassing, laboratory investigations, testing

requirements and release / stability data trending.

Performed on-site audits of CMO quality and testing operations to assess compliance relative to existing

quality agreements or due diligence for new testing contracts.

Participated as a core team member for the Genentech/Roche QC transition program. Seamlessly

transferred product and process knowledge related to: CMO oversight, release, stability and complaint

testing, and release data trending.

Trained and managed teams that implemented 5S practices in the laboratories. Housekeeping became

transparent and improved the efficiency of the laboratories. Led two, Six Sigma DMAIC projects.

Conducted internal self-audits of the laboratories to ensure all environmental health and safety standards

were met. Ensured on-going EH&S training requirements were met.

Maintained inventory controls and prepared audit reports for controlled drug substances and drug products

used or tested by the laboratory. Ensured reference standards and documentation were maintained.

Employed extensive use of electronic journals and pharmacopeias to resolve quality and product issues.

Initiated change control for pharmacopeia updates as required.

Participated in cross-functional production meetings for manufacturing issues and investigations.

Principal Scientist – Quality Management / Quality Control Chemistry

January 2000 – December 2001

Hoffmann-La Roche Inc., Nutley, NJ

Laboratory supervisor for a solids and liquids QC laboratory, managing all compliance, quality and

technical issues related to release, validation, complaint and stability testing of marketed and development

products. Managed up to 9 direct reports.

Significantly reduced the number of laboratory investigations through direct interaction with analysts at the

bench and by identifying assignable and root causes and initiating CAPA as appropriate. Participated in

laboratory recovery from cGMP deficiencies identified during prior FDA inspections.

Transformed the external perception of the laboratory to one in which gold standards of compliance and

quality were ways of life.

Ensured that interactions with quality assurance, validation engineering, production, process development

and production planners were transparent and aligned to promote and sustain compliance and quality

standards while maintaining customer expectations for delivery of services.

Ensured that local SOP’s, applicable to QC operations, were aligned with corporate SOP’s and

FDA/EMA/ICH guidelines. Authored SOP’s for new processes. Ensured that analyst SOP, Method and

GMP training remained current.

Partnered with the analytical development group to validate and transfer methods into the QC laboratories.

Managed all change control for internal and external method transfers.

Senior Scientist – Non-Clinical Drug Safety/Drug Metabolism

February 1997 – December 1999

Hoffmann-La Roche Inc., Nutley, NJ

Developed and validated LC/MS/MS methods for pharmacokinetic profiling and metabolite identification of

discovery molecular candidates.

Developed and validated HPLC methods for radiolabeled discovery candidates.

Performed drug-drug interaction and other P450 studies using microsomes and hepatocytes.

Evaluated PK parameters (bioavailability, intrinsic clearance, etc.) for development compounds using

microsome and in-vivo data. Co-authored several regulatory submissions.

Served as a team leader to explore implementation of LC-NMR for metabolite studies.

Participating member of the departmental SOP and CSV teams responsible for writing and review of

procedures and protocols.

Senior Scientist – Analytical R&D

May 1995 – February 1997

Hoffmann-La Roche Inc., Nutley, NJ

Team member for CMC technical writing and review for several biotech molecular entities, one of which

progressed to an approved IND. Technical writer/reviewer for several other biotech IND / NDA documents.

Led the Roche USA global initiative for implementation of capillary electrophoresis in protein/peptide and

chiral (small molecule) applications.

Employed extensive use of capillary electrophoresis to develop and validate methods for advanced protein

characterization.

Developed a capillary electrophoresis method to identify cysteine modifications in glycosylated proteins to

support MS/toxicological findings.

Reviewed and approved GMP release/stability data for IND / NDA biotech products.

Used statistical analysis to establish and validate criteria for limit of detection/sensitivity in residual DNA

analysis for an NDA biotech product.

Scientist – Pharmaceutical R&D

January 1989 – May 1995

Hoffmann-La Roche Inc., Nutley, NJ

Group leader (‘93-‘94) with two direct reports, managing NDA / IND CMC activities for three lead

compounds and post approval commitments for one marketed product.

Identified a binding phenomenon of a peptide antagonist on in-process filters. Developed and validated an

HPLC method for low level assay of the peptide antagonist that allowed continuing development of a novel

aerosol delivery system for the molecule.

Developed and validated a capillary electrophoresis method to assay spiked toxicology animal feed

samples. The method had general applicability and doubled the throughput of toxicology development

samples.

Developed and validated a solid phase extraction procedure for low level analysis of degradation

components of a vitamin D analog in a complex topical matrix. The method allowed subsequent HPLC

quantitation of low level degradation components not readily available from other methods of analysis.

Education

Concordia University, Montreal, Quebec B.Sc., Chemistry (Specialization, 60 credits)

Seton Hall University, South Orange, N.J. Completed course work for PhD.

Proposed Thesis: Transient Receptor Potential Vanilloid 1 and PIP2: Binding Site Structure and Dynamics

Training

• Product Quality Reviews- A Statistical Approach, David Begg Associates, 2006

• Conflict Management, Matteson Consulting Group, 2006

• Six Sigma, Green Belt Training, Quality America, Certificate, 2006

• Operational Excellence (OPEX) – LEAN/Six Sigma, Celerant Consulting, 2006

• Minitab, Minitab Inc., 2005

• Kepner-Tregoe, Problem Solving & Decision Making, Kepner-Tregoe Inc., 2004

• Management and Leadership Training, Rutgers University, Center for Management Development, 2003

• APR Technical Workshop – Variation and Control Techniques, KW Tunnell Consulting, 2002

• Right First Time, writing for corporate and regulatory documentation, Hoffmann-La Roche, 1995

• Capillary Electrophoresis, ACS, Washington, DC, 1995

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