Director/Manager

Riasat Masih Mobashar, Ph.D.

P.O. Box ***, Ridgewood, NJ 07451 Phone: 201-***-****

E-Mail: ***************@*******.*** 201-***-****

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Summary

A results-focused expert with more than 20 years of strong scientific and management experience in

leadership positions of increasing responsibility at Fortune 500 organizations. Experience includes

extensive interaction with manufacturing (Biologicals, Pharmaceuticals, and OTC) under compliance and

regulatory environment. Highly experienced in Consent Decree Gap Analysis and Remedial Work.

Extensive experience in internal/CRO Analytical R & D, Quality, Quality Systems (evaluation/

remediation),Validation (test method/equipment/process/cleaning), Technology Transfer, assessment/

acquisition/implementation of new technology under GMP/GLP, internal/CRO/CMO audits, and

Compliance. Strong working knowledge of FDA and other global authorities’ regulations. Highly

experienced in mentoring and development of staff. Extensive resource/project management, team

building, and leadership skills. Excellent preventive management, problem solving, interpersonal,

negotiation/persuasion, organizational, and communication skills.

• Analytical R & D; Method Development/Validation/Tech. Transfer (In-house subject matter expert,

Co-founder Divisional Test Method Validation Committee); ICH Guidelines; USP.

• Pre-contract auditing and selecting CROs/CMOs/CSOs. Strategic outsourcing and managing

outsourced work at multiple CROs/CMOs/CSOs.

• Internal audits (cross-functional/cross-departmental); interactions with regulatory agencies; attention

to details and compliance with internal and agency regulations; preparation of audit reports.

• Regulatory Submission Support (CMC Section of IND/NDA Writing/Reviewing; Documents/Reports

for areas of responsibility).

GMP/GLP/Compliance/Investigations (Chaired Divisional weekly investigations meetings).

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QC/QA (Release testing. Products/clinical study materials/intermediates/raw materials;

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Investigations).

Product Specifications (Chaired Divisional Multi-Site Subcommittee; Represented Global

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Quality on

Multi National Committees, reviewed documents for scientific accuracy and compliance).

Equipment Qualification (IQ/OQ/PQ), 21 CFR Part 11 (protocols/reports); Equipment

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Calibration Program Management; Change Control/Management.

Manufacturing and Surveillance Programs Support (Investigations); Cleaning Validation

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Studies/Methods; Process Validation Support; Formulation and Stability Programs Support.

Reference Standard Characterization and Certification Program Management.

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Budgets/Proposals/Justifications; New Business Development; Customer Service skills.

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Writing, reviewing/editing, and approving SOPs, validation (test

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method/equipment/process/cleaning) protocols and reports, and other GMP/GLP/CMC documents;

edited work of Scientific Writers.

Training and management of training programs. Preparation of training materials.

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Management of highly qualified scientists (mostly highly experienced Ph.Ds; some highly

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experienced MS/BS); Multiple projects simultaneously; Multiple labs; Staff

hiring/training/development.

Professional Experience

SNM Scientific, Ridgewood, NJ (2012 – Present)

Consultant, 2012-Present

• Provide expert Consent Decree support services in test method development and validation, equipment

qualification (IQ/OQ/PQ), cleaning validation, process validation, tech transfer, investigations, and

various other Quality and GMP functions.

• Perform gap analysis and write remediation plans. Assist with implementation of plans.

• Assist with third party assessments (manufacturers, suppliers, tech services providers, etc.).

• Conduct due diligence audits and inspections. Assist with regulatory authority audit readiness.

• Write, review, and edit protocols, reports, SOPs, and variety of other GMP documents.

• Work well as a team as well as independently.

GlaxoSmithKline, Clifton, NJ (2009 – 2012)

Team Leader/Manager, Quality, 2009 – 2012

• Managed day-to-day activities of Quality Laboratory in a fast-paced real time manufacturing in

GMP environment. Set priorities and made assignments. Directed staff’s work.

• Ensured timely testing and release of in-process and finished product samples to maintain

production speed and schedule. Managed timely testing for Stability, Process Validation,

Complaints, Investigations, and other special projects.

• Wrote, reviewed, and approved a variety of Quality, Manufacturing, and Packaging documents

• Performed and/or supervised performing of equipment and facilities audits and inspections.

• Ensured and approved cleaning and sanitization of manufacturing and packaging equipment

per Corporate/Site procedures and policies.

• Liaised Quality, Manufacturing, and Packaging functions to achieve common goals as a team.

• Recommended and implemented a number of GMP improvements in Quality, Manufacturing,

and Packaging functions as personal initiatives.

SNM Scientific, Ridgewood, NJ (2005 – 2009)

Consultant, 2005 – 2009

• Provided test method development, validation, tech. transfer, and investigations support.

• Served as an expert in assessment and remediation of test method validation, equipment IQ/OQ/PQ,

validation/qualification documents, and documentation procedures and practices.

• Wrote Cleaning Validation/Process Validation protocols and reports. Assisted with investigations.

• Conducted training and training documentation. Prepared training materials.

• Provided Regulatory Submission Support (CMC Section of IND/NDA Writing/Reviewing;

Documents/Reports).

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• Conducted due diligence audits and inspections. Provided project management support.

Schering-Plough, Union, NJ (2003 – 2005)

Manager, Global Analytical Sciences-Global Quality, 2003-2005

• Developed infrastructure of new department. Managed initial installation/automation/qualification of

large number (~ 200)/variety of instruments including computer hardware and software.

• Managed upgrading of LIMS.

• Managed writing of large number (>100) of SOPs/protocols/reports.

• Established new GMP laboratories.

• Managed method development/validation. Performed gap assessment; wrote reports/remedial plans.

• Directed daily workflow; Established goals and wrote performance reviews.

• Managed ongoing functions [equipment qualification/calibration/staff and vendor training/reference

standards certification (physical/chemical characterization), and change management].

• Directed investigations and report writing.

• Served on senior level cross-functional teams [tech. transfer, global specifications/monographs, global

standard documents, and cleaning validation].

Wyeth Pharmaceuticals, Pearl River, NY (1997 – 2003)

Group Leader (Assoc. Dir. Equivalent), Chemistry & Biochemistry QC, 2002-2003

Directed group of 20+ (5 direct reports/Admin. Assistant); established goals/performance reviews.

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Managed 5 labs. for release testing final products/intermediates/stability/clinical trial/container

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and

packaging materials/raw materials.

• Managed special studies and internal/CROs/CMOs tech. transfers. Wrote/reviewed/approved reports.

1 Prepared for/participated in pre-approval/periodic USA/international reg. agency/internal audits.

• Participated in product specifications setting.

• Provided Regulatory Submission Support (CMC Section of IND/NDA Writing/Reviewing;

Documents/Reports for areas of responsibility).

• Served on senior level teams [multi-site methods/specifications harmonization, preparation of internal/

CROs/CMOs tech. transfers, Divisional Documents, and internal/CROs/CMOs contract documents].

Group Leader (Assoc. Dir. Equivalent), Analytical Chemistry R & D, 1998-2002

Directed group of 20+ (4 direct reports/Admin. Assistant); established goals/performance reviews

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Managed extensive test method validation for Prevnar®, Wyeth’s blockbuster vaccine.

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Provided Regulatory Submission Support (CMC Section of IND/NDA Writing/Reviewing;

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Documents/Reports for areas of responsibility).

Managed internal/CRO method development/validation/tech. transfers. Reviewed/approved

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internal/CRO protocols/reports.

Directed production/in-process/complaint testing/investigations & reports. Supported process

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validation.

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Performed CRO/CMO technical evaluations/document audits/operations and facilities inspections.

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Prepared for/participated in pre-approval/periodic USA/international reg. agency/internal audits.

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Served on senior level cross-functional teams.

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Senior Research and Development Scientist, Analytical Chemistry R & D, 1997-1998

• Developed and validated variety of analytical methods. Wrote protocols, reports, and SOPs.

• Supervised/trained less junior colleagues. Reviewed their work. Assisted with performance reviews.

Additional R & D Experience, 1983-1996: New Drug Development Lab./Emory University Medical

School, Atlanta, GA; Biometallics, Princeton, NJ; Sigma Lab., Tucson, AZ; NAPCO, Linden, NJ;

Rutgers University, New Brunswick, NJ; University of Arizona, Tucson, AZ; Center for Photochemical

Sciences/Bowling Green State University, Bowling Green, OH.

Teaching Experience, 2007-2008; 1981-1987: Adjunct Faculty, Bergen Community College, Paramus,

NJ, 2007-2008; Graduate Teaching Assistant, Rutgers University, 1983-1987; Graduate Teaching

Assistant, Quaid-i-Azam University, 1982-1983; Chemistry Teacher, St. Paul’s Cambridge High School,

Rawalpindi, 1981-1982.

Instrumentation and Laboratory Skills

Experienced in variety of modern analytical techniques: HPLC/UPLC/IC (reverse/normal phase, ion

exchange, size exclusion, etc.; UV, PDA, RI, MALLS, and electrochemical detectors), GC, FT-IR,

NMR, UV-Vis., Karl Fisher, TGA, DSC, AA, DCP, and variety of electro-analytical techniques.

Experienced in traditional separation/purification techniques (column chromatography; analytical/prep.

TLC; extraction; distillation; lyophilization; crystallization). Experienced in wet chemistry methods,

derivatization techniques, and sample prep. techniques. Familiar with and managed work performed

using various other techniques.

Education

Ph. D. (Chemistry): Rutgers University, New Brunswick, NJ, 1989

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M. Sc. (Chemistry): Quaid-i-Azam University, Islamabad, 1981

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B. Sc. (Chemistry/Biology): Government College/University of Punjab, Rawalpindi, 1979

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Selected Analytical Chemistry Graduate Courses: Separation Sciences; Electro-analytical Chemistry;

Advance Spectroscopy I (IR/FT-IR, NMR, UV-Vis.); Advance Spectroscopy II (AA, DCP, NMR);

Advance Analytical Chemistry (GC, MS/GC-MS, TGA, DSC); Analytical Techniques for Water Analysis.

Selected Short Courses: Understanding Reverse Phase Column Selection (Waters Corp.); Modes of

HPLC (Keystone Scientific); Introduction to Statistics (SLF Consulting); How to Develop, Validate, and

Troubleshoot GC Methods (ACS); DX500 Operational Techniques and Maintenance (Dionex Corp.).

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Continuing Education/Training: A number of internal and external courses on management

(personnel/ projects/resources), Labor Law, GMP/GLP, Compliance, Audits/Inspections, Investigations,

Documentation, Safety, and Computer Software.

Honors and Awards

NIH Funded Postdoctoral Research Fellowship: Emory University Medical School, Atlanta

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Morgan Fellowship (Outstanding First Year Graduate Student): Rutgers University, New

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Brunswick

Junior Research Fellowship: Quaid-i-Azam University, Islamabad

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Second Position in M. Sc. (Analytical/Inorganic Chemistry) Graduating Class, Quaid-i-Azam

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University, Islamabad

First Position in B. Sc. (Chemistry/Biology) Graduating Class, Gov’t College, Rawalpindi

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First Position in High School Graduating Class, C.T.I. High School, Sialkot

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Professional Affiliation: American Chemical Society/Analytical Chemistry; New Jersey Pharmaceutical

Association for Science and Technology

Professional Networks: Biotech & Pharma Professionals Network; Chromatography and Spectroscopy-News and Career

Exchange; FDA Regulated Industries Group; FDA-RTF Solutions; Kaizen (Continuous Improvement) Experts; Pharmaceutical

Professionals Worldwide Network; Quality and Regulatory Network; Quality Experts; Eye On Quality; Regulatory Compliance

Association; Subcontracting and Outsourcing Network; Validation and Compliance Consulting; Validation and Regulatory

Compliance Professionals Group; Validation Xpress.

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