EXPERIENCE/DUTIES:

Karuna Therapeutics, Boston MA (Remote)/ Bristol Myers Squibb

(Karuna Therapeutics was acquired by BMS in March 2024)

03/24 – 03/25 (BMS) Associate Director   Preclinical QA  

09/22 – 03/24(Karuna Tx) Associate Director   Preclinical QA

  - Lead Preclinical QA to develop tactical and operational audit plans, utilizing a data-driven, risk-based process to deliver the Preclinical QA audit strategy.  

  - Oversee the development and management of Preclinical QA and Preclinical audit program, including audit scoping, preparation, execution, follow-up, and Corrective and Preventive Action (CAPA) to meet regulatory requirements, industry and internal standards.  

  - Perform GLP study protocol and report QA review, bioanalytical method validation protocol and report review, and other GLP document review as applicable.  Ensure effective performance of pre-inspection visits are performed to drive inspection readiness.

   - Collaboration with preclinical business functions to promote a culture of proactive risk management.  

  - Demonstrate leadership and sound business ethics in review of potential scientific misconduct or fraud instances and adequate escalation of critical compliance issues. Proactively identify quality events and escalate concerns in a timely manner; advise solutions to quality concerns in the Preclinical domain.  

  - Participate and contribute to governance board discussions, regarding Preclinical risk and quality/compliance issues. Support the preparation and execution of various governance bodies (e.g., Management Review etc.).

ICON Plc., Whitesboro, NY  13492 

04/17 – 09/2022 QA Manager   ICON Bioanalytical Laboratories

  - Manage a group of QA auditors, ensuring appropriate training commensurate with each role, building team trust, enhancing discussion of audit strategies, and encouraging personal and professional development.

•   Lead the team in a transition to use of a risk-based auditing approach

•    Impact business performance through the daily management of employees including setting of employee performance objectives and conducting performance reviews

•   Lead execution of team plans, sharing accountability for delivery of team’s end results

  - Preparation, conduct and follow up of Sponsor and Regulatory audits, and represent QA internally and with third parties (e.g., technical visits). 

  - Plan and conduct QA audits and reviews as required to assure that clinical and GLP studies managed by ICON are of the highest standards and in compliance with protocols, SOPs, analytical plans and applicable regulations.   

 - Prepare training presentations for departmental staff, IBL operations staff, and corporate QA staff members, on the ICON quality system, and to enhance GLP knowledge across the company.  

  - Champion ICON Bioanalytical Laboratories at corporate meetings and external events/conferences. 

Bristol-Myers Squibb Research & Development, Princeton, NJ  08540

05/12 – 04/2017 Compliance Specialist   RDQ-QLP (formerly GQRC-Analytical)  

11/08 – 05/12 Senior Auditor   GQRC-Analytical  

10/05 – 11/08 Auditor           GQRC-Analytical

 - Monitor ongoing and completed key clinical studies, in particular Bioequivalence and Biocomparability Studies, for compliance, with an emphasis towards FDA Bioresearch Monitoring Chapter 48 In-Vivo Bioequivalence, Guidance for Industry - Bioanalytical Method Validation, Standard Operating Procedures (SOPs) and written protocols in order to ensure data integrity. 

 •  Responsible for providing documentation to foreign Health Authorities which support BMS’s use of CRO partners for the conduct of GLP and/or clinical bioanalysis.

 •  Perform inspections and audits to assess the facilities, equipment, procedures, methods and      documentation systems used in the generation of drug safety data.

 •   In-depth audits for accuracy and consistency of study data and reports.

  - Lead audits and inspections in other areas of regulatory concern.  Expertise specifically suited for biologics. 

  - Create and give specialized training and metrics presentations to key stakeholders, fellow auditors and external meeting participants. 

   - Conduct New Hire GLP and Inspection Readiness training.    - Participate in Regulatory Awareness and Compliance Team (ReACT) meetings to assess the impact and provide recommendations for draft guidance for industry documents impacting the bioanalytical and/or Bioequivalence space, as well as provide input within cross-functional (cross department, cross company) process and collaboration teams.

- Member of GLP-Analytical Senior Leadership Team.

7/04 – 10/05 Research Scientist I           Bioanalytical Sciences  

3/01 – 6/04 Associate Research Scientist II   Bioanalytical Sciences  

4/99 – 3/01 Associate Research Scientist I   Bioanalytical Sciences

  - Validate and run routine analytical procedures using LC/MS/MS (Micromass Quattro LC, Sciex 3000 and 4000) in either positive or negative electrospray mode for the determination of drug concentrations in biological specimens in support of pre-clinical and clinical drug disposition studies. 

  - Member of departmental HPLC and Liquid Handler teams for 21CRF Part 11 Compliance.  Create test scripts and conducted IQ/OQ and UAT testing for LC, MS and robotic systems.    

  - Train new individuals in the maintenance, calibration and routine procedures associated with           instrumentation, pipettes, data regression, analytical assays and daily responsibilities.   

  - Supervise and train union and temporary employees in routine sample analysis, and in the support of other ongoing projects.  

   - Act as departmental liaison at project team meetings, providing project status updates both to the team and to supervisors. 

5/95 – 4/99 Associate Research Scientist I   Bioanalytical Sciences

  - Develop and validate analytical procedures using ELISA technology for the determination of drug     concentrations in biological specimens in support of pre-clinical (GLP and non-GLP studies) and clinical drug disposition studies.

  - Write and submit validation reports for distribution within the organization.- Train new individuals in the use of mainframe applications related to data regression and database use.

State University of New York, Buffalo, NY  14215

 2/94 - 5/95 Research Support Specialist Psychiatry Department

  - Responsible for the entire spectrum of daily laboratory operations which included the planning, coordination, and execution of synchronous techniques encompassing multiple samples, resulting in the preparation, storage and cataloging of samples for future analysis.  

 - Perform sample separations and radioimmunoassays.

Sterling Winthrop Pharmaceuticals Research Division, Rensselaer, NY  12144

5/92 - 8/93 Research Scientist        Drug Metabolism and Pharmacokinetics   

7/89 - 5/92 Associate Research Scientist Drug Metabolism and Pharmacokinetics

  - Develop and validate analytical procedures for ELISA and HPLC technologies to be used routinely for the determination of drug/metabolite concentrations in biological specimens in support of pre-clinical and clinical drug disposition studies. 

  - Analytical/assay experience for HPLC includes solid phase and liquid-liquid extraction in conjunction with switching column technology and Fluorescence or Ultraviolet detection.  

  - Train other individuals in HPLC validation and departmental documentation procedures.  Assist in     troubleshooting HPLC problems.

  8/86 - 7/89 Research Technician       Oncology/Endocrinology

  - Run non-commercial and kit RIA's for endogenous and experimental drug-induced levels of reproductive, pituitary, and adrenal hormones for Prostatic Disease and Endometriosis programs.  

  - Routinely medicate and retrieve blood from small research animals in support of the above programs. Necropsy test animals and report data using several in-house databases.  

  - Perform Competitive Binding assays for a variety of reproduction-related receptors.

Stiefel Research Institute, Oak Hill, NY 12460

5/86 - 8/86 Technician                Quality Control

  - Test raw materials and finished products using USP methods for titration chemistry and other         methodologies.

COMPUTER TRAINING:

 MS Office Applications (Word, Excel, Powerpoint, Outlook)

 Data Capture and Storage:  Multichrom, Millennium, Watson, MassLynx, Analyst, NuGenesys

Robotics:  Biomek 1000 Automated Work Station, Tecan Genesis Diluter 

Data Management: SAS, PRISM, PCRIS, IDIS, ISIS, Box

Quality Assurance: QAAD, Trackwise, VeevaVault 

Electronic Laboratory Notebook: CambridgeSoft, IDBS

Scientific/Managerial Training:

Quattro LC Operation/Quantification (1999); Practical HPLC Troubleshooting (1999); The Successful Negotiator (2002); Transition to Supervision I (2003); Transition to Supervision II (2004); Introduction to Pharmacokinetics for Non-Kineticists (2005); Project Management Fundamentals (2013); Project Management (2014); First Level Leadership (2015)

QA/RA Training:

In-house: 

GLP Good Documentation Practices (2002); Introduction to ICH Good Clinical Practice (2003); Audit Trails and Part 11 (2003); In-house CRO Audit Training (2005) 

SQA: Advanced Training: 

Good Laboratory Practices - 22nd Society of Quality Assurance Annual Meeting (2006); Bioanalytical Training - 23rd Society of Quality Assurance Annual Meeting (2007); SQA Leadership Development - 32nd Society of Quality Assurance Annual Meeting (2016); QA Consulting - 32nd Society of Quality Assurance Annual Meeting (2016)

Certificate in Drug Development, as part of Temple University QA/RA program: 

Drug Development (2008); Good Laboratory Practices (2008); Food and Drug Law I (2009); Quality Audit (2009)

Ongoing training for a Masters in Regulatory Affairs/Quality Assurance, at Temple University: Biologics/Biosimilars (2015); Bioethics (2016)

PUBLICATIONS/PRESENTATIONS:

Juniewicz, et al.  The Effect of the Steroidal Androgen Receptor Antagonist, Win 49,596, on the Prostate and Testis of Beagle Dogs.  Endocrinology 126:2625.

Damle, et al.  Development of an Immunoassay for BMS-191352, a Single-Chain Immunotoxin, and its Application to Toxicokinetic Studies.  Journal of Immunoassay 19(2&3), 145-165.

  Bello, et al.  Ex Vivo Serum Protein Binding of BMS-284756: Impact on the Unbound AUC/MIC Ratio for Streptococcus pneumoniae.  ICAAC Meeting, Chicago, IL, Dec 16-19, 2001.  Poster 45.

Stewart, et al.  Safety, Tolerability and Pharmacokinetics of BMS-284756, a Novel Des-F (6)-Quinolone, Following 28 Days of Once Daily Oral Dosing in Healthy Subjects.  ICAAC Meeting, Chicago, IL, Dec 16-19, 2001.  Poster 46.

Christopher, et al.  Metabolism of [14C]BMS-528215 (6-Hydroxy-Buspirone) after Oral Administration to Mice, Rats, Dogs, Monkeys and Humans.  Drug Metabolism Reviews 37(2):108.   ISSX/JSSX Meeting, Maui, HI, Oct 23-27, 2005.  Abstract 182.

Zheng, et al.  Evaporation-free Automated Solid Phase Extraction Approach for Faster Bioanalysis by LC/MS/MS in Support of Toxicokinetic and Pharmacokinetic Studies.  54th ASMA Conference, Seattle, WA, May 28-June 1, 2006.  Abstract 1790.

Parker, DM.  Crossing the Lines (between GLP and Bioanalysis).   23rd Annual Society of Quality Assurance Meeting, Austin, TX, April 29 - May 4, 2007.  Poster 14.

Parker, DM.  The Science of Immunoassays - What Every Bioanalytical Auditor Should Know.  Oral presentation given at Mid-Atlantic Region Society of Quality Assurance (MARSQA) Membership Meeting, July 19, 2007

Parker, DM.  ISR: Incurred Sample Reanalysis.  PhARMA Bioresearch Monitoring Annual Meeting, Rockville, MD, September 23, 2009.  Poster 3.

Parker, DM.  DBS: Implications from the Regulatory Perspective.  21st Annual BMS Symposium, November 7, 2011, Poster 194

Parker, DM.  The Biologics Super-Highway: An Auditor’s On-Ramp.  Presentation given at MARSQA Membership Meeting, June 25, 2015.

Parker, DM.  Unexpected Event Investigations in Small Molecule Bioanalysis.  Applied Pharmaceutical Analysis (APA) Annual Meeting, Bangalore, India, February 23, 2016.

Parker, DM, Podbielski, L. and Wagner, K.  Auditing Biologics for GLP Compliance.  Society of Quality Assurance Annual Meeting, Grapevine, TX, April 5, 2016.

Parker, DM.  Unexpected Event Investigations in Small Molecule Bioanalysis.  26th Annual BMS Symposium, May 2016, Poster 280.

Parker, DM.  The Biologics Super-Highway, and Unexpected Event Investigations.  Presentation given at joint MARSQA/NERCSAQ Training, September 23, 2016.

Parker, DM.  Unexpected Event Investigations in Small Molecule Bioanalysis.  Land O’Lakes Bioanalytical Conference, July 13, 2017, webinar.

Parker, DM and Podbielski, L.  The Biologics Super-Highway: An Auditor’s On-Ramp.  Half-Day Training at SQA Quality College, 

• September 2015

• April 2017

Orr, S., Savoie, N., Parker, D., and Rogenthien, S.  An Auditor’s Primer on the Science, Practice and Auditing of Chromatography and Mass Spectrometry.  Full day session.  SQA Quality College, 

• March 2017

• April 2018

• September 2020

Parker, DM.  Archival Challenges in a Bioanalytical Laboratory.  Health Sciences Records and Archives Association (HSRAA), Let’s Talk event, June 17, 2022, webinar.

OTHER:

           Member of the Society of Quality Assurance since 01/2006.  Member of the GLP Specialty Section (GLPSS), 

           Member of Mid-Atlantic Region of the Society of Quality Assurance 2015-2025.  MARSQA Board of Directors 2016-2017.Bioanalytical Specialty Section 

           Member of Toastmasters, International since 01/2002. Club Sergeant-at-Arms 07/02-12/02. Club President 07/11-06/14, 07/15-present. Competent Toastmaster in January 2004. Competent Communicator Bronze in June 2007.  Competent Leader in February 2014.  Advanced Leader Silver in January 2016.  Competent Communicator Silver in May 2016. TESOL Certification through Oxford, Aug-Nov. 2014 Certified Massage Therapist in the state of New Jersey, 2002(BASS) and the Biotechnology Subsection. Lead for Biotech SS 2016-2017.

REFERENCES:

                 Available upon request.