Calin G. Znamirovschi, Ph.D.

*** ******* **** **** **** Beach, FL, USA Tel. 561-***-**** adgrqi@r.postjobfree.com

Summary

Analytical scientist, manager, and consultant with over 20 years of broad experience in the global pharmaceutical, analytical instrumentation, and clinical industries.

Education

Ph.D. – Analytical Chemistry - Michigan State University

Master of Business Administration - University of Maryland Global Campus

Master of International Management - University of Maryland Global Campus

Master of Science – Industrial Chemistry - University of Cluj-Napoca (Romania)

Employment History

04/2019 – present Access Medical Laboratories, Inc. Jupiter, FL

Director of Mass Spectrometry

Supervision and training of medical technologists, scientists, and technicians.

Review of laboratory data packages in support of medical testing result release.

Performance of instrument qualification and methods validation in accordance with CAP regulations.

Maintenance of laboratory systems in a state of compliance and inspection readiness.

09/2018 – 04/2019 ProPharma Group (B Braun Medical, Inc.) Irvine, CA

Senior Consultant – Quality Assurance Oversight

Provided QA oversight support for all aspects of Quality Control laboratories in alignment with current corporate and site SOPs, FDA Guidance and cGMP regulations.

Performed timely and accurate review of analytical data packages in support of commercial product release and lot disposition.

Supported investigations for production and laboratory errors, discrepancies, failure to meet specifications, CAPA, and risk management program.

03/2018 – 09/2018 ProPharma Group (Pfizer, Inc.) Rocky Mount, NC

Senior Investigator / Consultant – Manufacturing Operations

Performed manufacturing investigations for Large Volume Solutions, Terminally Sterilized Filling, and Aseptic Filling operations using gQTS (TrackWise) for QAR.

Led cross-functional team investigation efforts per Method 1 (M1) framework for root cause analysis and effective CAPA to meet cGMP and regulatory requirements.

08/2014 – 01/2018 Sancilio Pharmaceuticals Company Riviera Beach, FL

Director – Analytical Sciences

Built and managed a high throughput LC-MS laboratory to enhance existing cGMP testing capabilities for API and drug product (solid dosage and soft gel capsules).

Achieved 80% reduction in testing turnaround time by developing and validating complex UHPLC methods.

Designed and executed internal protocols for instrument qualification and maintenance which reduced costs by 45% over service outsourcing.

Provided guidance and support for analytical method development, validation, and implementation, with an emphasis on chromatography and mass spectrometry.

Conducted failure investigations (OOS/OOT), root cause analysis, and CAPA.

Maintained continuous state of compliance and inspection readiness of analytical laboratory through timely and effective resolution of scientific and technical challenges.

Actively participated in FDA audits and elaboration of company responses.

Directed resources teams and facilitated interdepartmental initiatives to optimally meet the multiple internal and external project deadlines.

Ensured meeting corporate objectives through training, development, motivation, and performance management of laboratory staff.

01/2005 – 03/2014 Thermo Fisher Scientific West Palm Beach, FL

Senior Technical Instructor (LC-MS)

Customer training and technical support in LC-MS instrumentation, software, service, and operation (TSQ, LTQ-Orbitrap, Q-Exactive)

Designed 6 training modules and delivered standardized and custom training to over 1400 internal and external customers in North America and Europe.

Led a cross-departmental practical process improvement (PPI) team to streamline customer focus and complaint handling.

LC-MS method development in support of service portfolio expansion, sales initiatives, application notes and product marketing, as part of cross-functional strategic teams.

10/2003 – 04/2004 Precept Clinical, LLP Vienna, VA

Senior Consultant

Developed 5 core competency and 3 on-the-job global training manuals as part of remediation activities at Cordis LLC Puerto Rico (a Johnson & Johnson company)

Trained and evaluated laboratory and management personnel according to updated performance metrics

Audited investigations and corrective action documentation in laboratory and quality assurance records.

Operational planning, organizational alignment of global training programs, performance management, and project management.

03/2001 – 06/2003 Eurofins (Cerep, Inc.) Redmond, WA

Manager – Quality

Managed laboratory quality systems, reviewed, audited, and approved bioanalytical data and reports in compliance with Good Laboratory Practices

Streamlined standard operating procedures and aligned documentation practices at two locations (US and France)

Developed and executed analyst training programs, operating procedures, work instructions, documentation practices, and archiving of records.

01/2000 – 03/2001 Aptuit (ChemSyn Laboratories) Harrisonville, MO

Group Leader – Analytical Chemistry and Quality Control

Supervised, trained, and evaluated eight scientists and technicians (B.S. to Ph.D.) involved in multi-shift operations, in a high-potency API manufacturing facility.

Designed method development, transfer, and validation protocols, executed equivalency studies in support of contract manufacturing and laboratory services

Coordinated the qualification, scale-up, process development, and validation of synthetic processes for high-potency intermediates and active pharmaceutical ingredients (API), for domestic and global customers, under GMP.

Established key performance metrics to monitor analyst performance and efficiency.

Audited domestic and international suppliers of materials and analytical services.

Liaised with FDA to maintain full compliance with updated regulatory requirements.

07/1998 – 11/1999 Cell Therapeutics, Inc. Seattle, WA

Senior Research Chemist – Analytical Development

Developed, validated, and transferred analytical methods, in support of in-house and outsourced manufacturing operations.

Developed specifications and quality control strategy for raw materials, in-process testing, API, and finished products.

Co-authored analytical CMC sections of two regulatory submissions (methods, analytical validation, reference standards, impurity profiles, specifications).

11/1996–10/1997 Hauser, Inc. Boulder, CO

Senior Chemist – Analytical and Product Development

Developed, qualified, and validated analytical methods in support of R&D and custom synthesis.

Developed and optimized the analytical control methodology for the synthetic process for N-debenzoyl-paclitaxel, a precursor of semi-synthetic paclitaxel.

Part of the team responsible for qualification and validation of small scale and scale-up methodology for a novel manufacturing process for paclitaxel API.

Areas of Expertise

Training expertise in applied analytical chemistry, broad technical instrumentation support, and service.

Management, mentoring, training, supervision, and evaluation of staff in multi-shift operations, in a global business environment.

Strong business acumen and commitment to driving customer allegiance.

Leadership skills in implementing and maintaining a high degree of integrity, intensity, innovation, and involvement.

Strategic alignment, practical process improvement, and operational excellence in a global industry setting.

Project management and administration, planning, timelines, resources, and budget.

Global strategy development, key performance indicators, risk assessment and mitigation.

Activity-based cost and resources management for service portfolio support, research, validation, marketing, and production activities.

Analytical and bioanalytical method development, design, transfer, support, and validation (HPLC, UPLC, LC-MS, ICP-MS), in support of regulatory submissions.

Quality-by-Design (QbD) study management in support of drug product formulation and analytical development.

Operation, qualification, troubleshooting, service, and maintenance of multi-vendor HPLC, UPLC, ICP-MS, and LC-MS instrumentation.

Management of technology transfers and global quality agreements.

Development, qualification, and validation of analytical and bioanalytical methods in support of compound characterization and pharmaceutical processes (drug discovery, bench-scale research, pilot, scale-up, clinical supply, and commercial manufacturing).

Audit, qualification, and management of domestic and global contract manufacturing and analytical testing facilities, under cGMP compliance.

Quality Assurance oversight in support of analytical laboratories and manufacturing.

Excellent scientific writing, communication, team building, and presentation skills.

Employment Authorization

United States of America

European Union

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