Summary
Overview
Work History
Education
Skills
Organizations
Publications
Timeline
Generic

Mark O’Dell

Brownsburg

Summary

Senior Director of Bioanalytical Operations with expertise in leading Logistics, Sample Inventory, Assay Development, and Sample Analysis teams. Proven track record in executing pharmacokinetics, toxicokinetics, anti-drug antibodies, and ELISA assays, ensuring operational efficiency and strategic collaborations. Demonstrated success in process optimization and operational restructuring, providing scientific and technical guidance to external clients. Committed to driving business strategy and enhancing project execution in a dynamic environment.

Overview

20
20
years of professional experience

Work History

Senior Director of Biological Operations

B2S Life Sciences
Franklin
07.2023 - Current
  • Oversees development of analytical methodologies, protocols, and/or test procedures of immunoassays.
  • Oversees validation and sample analysis of bioanalytical assays to support pharmacokinetics (PK), and anti-drug antibodies (ADA).
  • Reviews method development data, validation reports, and bioanalytical reports.
  • Serves as test site management.
  • Directs bioanalytical support for work performed at other contract research organizations (CROs) to ensure quality, regulatory requirements, and industry practices for good laboratory practice (GLP), good clinical practice (GCP), and good manufacturing practice (GMP) are followed.
  • Contributes to technical reports and presents results at periodic project review meetings.
  • Delivers updates as part of the senior leadership in context of overall project goals.
  • Assumes departmental responsibility for projects and participates as representative for internal and external meetings, as requested.
  • Complies with applicable regulations.
  • Maintains proper records in accordance with standard operating procedures (SOPs) and policies.
  • Designs and performs scientific experiments with a pre-defined goal including developing new methodologies, protocols, and/or test procedures that contribute to core group research goals and reflect expert knowledge.
  • Contributes to defining team goals and collaborates with scientists within and outside functional areas in achieving the goals.
  • Participate as a representative on multiple project teams and contribute to defining expertise-related aspects of overall program goals.
  • Prepares clear technical reports, publications, and oral presentations and independently communicates results in the form of reports and/or presentations.
  • Writes, edits, and revises standard operating procedures (SOPs), qualifications, and forms.
  • Completes accounting for assay and pass-through reconciliations for current projects.
  • Assists and coaches associates and technical staff by assisting with experimental design and troubleshooting of bioanalytical challenges.
  • Trains and mentors new/existing employees in assay development techniques and equipment use and maintenance.
  • Report any laboratory equipment that is out of compliance to the appropriate personnel.
  • Provides oversight of Logistics group, that contains sample management and equipment compliance and maintenance.
  • Other duties as assigned.

Associate Director of Lead Scientists for Global iChem Bioanalytical Services

Labcorp drug Development
Indianapolis
01.2020 - 07.2023
  • Globally Manages the iChem Lead Scientists, driving alignment of global functional objectives for iCHem Lead Scientists teams and oversees all aspects for scientific delivery for iCHem BioA studies Globally.

Associate Director of Bioanalytical Services Indianapolis

Covance
Indianapolis
06.2018 - 01.2020
  • Successfully Managed a Scientific Group conducting multi- disciplined studies to generate high quality scientific results at the Indianapolis Site. Served as Group lead for the site.

Associate Scientific Director

Eurofins
St Charles
08.2016 - 06.2018
  • Develops client scientific and regulatory relationships (existing and new).
  • To provide guidance and oversight for compliance and scientific integrity of the studies to ensure that studies are performed in a compliant manner.
  • To define scope of work, focus on the project and consultation to the client.
  • To define the appropriate technical approach to accomplish the clients requirements.
  • Provides Program Managers with scope of the work, estimates of time required to complete the project, level of technical challenges for expectation setting and scientific input for use in proposal preparation.
  • To present proposal to clients for new clients and new services and address any concerns from the client.
  • Proposes the expertise needed for the study directors, principal investigators (GLP) or scientific director (GCP and GMP) and lead scientists (for assay development studies) for each client study based on the client requirements and experience with the client.
  • Serves as Study Director, Principal Investigator or Scientific Director or Lead Scientist as needed.
  • Accountable for sign off of validation plans and reports as provided by the validation team.

Associate Director, Method Development and Validation

Eurofins
St Charles
11.2016 - 08.2017
  • Manages team to ensure on-time delivery of services according to internal and external customers program needs.
  • Manages department to drive schedules that meet client projects, planned revenue, and profit targets.
  • Responsible for data review, analysis review and ensuring accuracy and integrity of data reporting
  • Provides scientific guidance that supports technical writing and final review of Validation Plans and Reports as required.
  • Provides guidance and oversight for compliance and scientific integrity of the studies to ensure that the studies are performed in a compliant manner.
  • Develops, designs, executes and manages the Principal Investigator program within the department including role definition, identification and development of PI candidates, training of Scientists, support and oversight of acting PI’s
  • Responsible for the data developed by the scientist and department to insure compliance with study requirements, accuracy and consistency and compliance with the regulatory requirements
  • Plans and coordinates the daily service operation activities with the appropriate staff and related operation/activities as needed ensuring the work is scheduled and completed to deliver data and reports to clients in a timely manner in compliance with regulations and the company’s quality system.
  • Understands and follows all procedures and processes required for work performed under Regulatory Compliance (e.e. GXP, FDA/GLP and GCP, OECD, CLIA, etc) and attend annual GLP training.
  • Directs investigations of service operations, such as deviation reports, non-conforming reports, corrective action reports, etc. Produces documentation according to established standards.
  • Reviews and approves operations documents to assure consistency with regulatory standards and requirements (i.e. SOPs, batch records, training records, etc.)
  • Develops process improvements to drive efficiency gains while maintaining highest quality levels.
  • Mentors and develops employees through objectives and performance management
  • Manages team to ensure provision of high level of customer and technical service support for all services.
  • Facilitates flexibility within team to meet shifting business needs.
  • Develops new ideas for new services offerings.
  • Contributes to tactical and strategic marketing practices for site services.
  • Implants and nurtures the corporate values within the department and guaranteed commitment to these by all team members.
  • Provides technical input to business development activities and in support of client relationships, as required
  • Conducts all activities in a safe and efficient manner
  • Strong understanding and practice of project management skills
  • Applies GMP/GLP in all areas of responsibility, as appropriate and understands and follows all written procedures that apply to the function of the position.

Laboratory Manager / Site lead for Immunochemistry

Covance
Indianapolis
04.2015 - 11.2016
  • Provides management direction to designated groups
  • Performs evaluations, salary administration, staffing decisions and other supervisory activities for the group and site
  • Develops skills of supervisors and through them, scientists and technical staff
  • Assures quality data collections
  • Independently tracks, analyzes, and provides recommendations regarding departmental financial data, particularly related to forecasting, revenue production and cost management.
  • Interprets and implements policies affecting staff, the fiscal management, and the technical management of the assigned group.
  • Effectively works with North American and global counterparts to ensure consistency of process within business units.
  • Assists in planning, marketing and project activities for assigned group.
  • Contributes to the establishment and implementation of fiscal, technical, marketing, and staff development goals.
  • Maintains client contacts and establishes new contacts for specific service or market segments.

Operations Team Lead, Development / Validation, Senior Scientist

AIT Bioscience, Ligand Binding Assay (LBA) group
Indianapolis
05.2013 - 04.2015
  • Operations team lead, development / validation / production. Involved in scheduling, scopes of work, team financial information (current and projections) and oversight of projects with six direct reports and three indirect reports to support studies in Pharmacokinetics, Immunogenicity (Anti-Drug Antibodies), Neutralizing antibodies and Biomarkers.
  • Aids in the support of Electronically Laboratory Notebook templates and experiments to support various areas of method development, validation and sample analysis via IDBS (Image DataBase Search program) E workbook suites
  • Serves as Principal Investigator for projects.
  • Point of contact for group that reports to senior management.
  • Point of contact on projects for new, current and exploratory clients.
  • Lead during conferences for projects and discussion.
  • Coordinates method transfers for new and existing clients.
  • Coordinates daily and weekly group meetings to address laboratory issues and scientific discussions.
  • Serve as Radiation Safety Officer, design and implementation of database for radioactive inventory.
  • Develop and validate new ligand binding assays (e.g., R adio I mmuno A ssay, E nzyme L inked I mmuno S orbent A ssay, and M eso S cale Di scovery) and other analytical procedures to conduct research and experimentation of commercial or in-house products for quantitative and qualitative analysis in a GLP environment, and deliver those methodologies to LBA (Ligand Binding Assay) personnel.
  • Review of analyzed samples in the production department in a GLP regulated environment and non regulated environment.
  • Review of statistical reports generated used to establish cut point for anti-drug antibody assay.
  • Provide support for the laboratory by review of preparations for standards and specifications for products and tests, troubleshooting problems with analytical methods, developing and improving manufactured products, and conferring with scientists regarding research.
  • Exert scientific leadership to the technical staff and devise methods, formulas, and processes for the solution of technical problems that may arise.
  • Prepare Standard Operating Procedures, validation plans, technical papers, instrument qualifications and scientific reports.
  • Promoted from Senior Scientist (January 2014)

Operations Team Lead, Development / Validation, Scientist III

EMD Millipore, Discovery & Developmental Solutions
St Charles
03.2005 - 05.2013
  • Operations team lead, development / validation. Involved in scheduling, overseeing projects with seven scientists reporting to support studies in Pharmacokinetics, Immunogenicity and Biomarkers.
  • Point of contact on projects for new, current and exploratory clients. Lead during conferences for projects and discussion.
  • Coordinates method transfers for new and existing clients.
  • Develop and validate new immunoassays (e.g., RIA, EIA, MSD and Immunohistochemical) and other analytical procedures to conduct research and experimentation of commercial or in-house products for quantitative and qualitative analysis in a GLP environment, and deliver those methodologies to Regulatory Compliant Laboratory personnel.
  • Review of analyzed samples in the Discovery and Development Solutions department in a GLP regulated environment.
  • Provide support for the laboratory by review of preparations for standards and specifications for products and tests, troubleshooting problems with analytical methods, developing and improving manufactured products, and conferring with scientists regarding research.
  • Exert scientific leadership to the technical staff and devise methods, formulas, and processes for the solution of technical problems that may arise.
  • Prepare Standard Operating Procedures, validation plans, technical papers, and scientific reports
  • Promoted from Scientist II (January 2011)

Scientist II

Millipore
St Charles
01.2009 - 01.2011
  • Development and validation of immunoassays for use in the Regulatory Compliant Laboratory.
  • Management of Client relationships and projects
  • Coordination and Training of junior scientists and analysts
  • Writing of Technical Reports, SOPs, and Training Documents
  • Promoted From Scientist I – January 2009

Scientist I

Millipore
St Charles
03.2005 - 01.2009
  • Development and validation of immunoassays for use in the Regulatory Compliant Laboratory.
  • Analysis of clinical and pre-clinical samples in validated immunoassays.
  • General Laboratory duties including reagent preparation, reagent qualification, equipment maintenance, and documentation.

Education

Masters of Arts & Science - Biotechnology

Washington University
St Louis, MO
12.2009

Bachelor of Arts and Science -

Southern Illinois University
Carbondale, IL
12.2000

Skills

  • Analytical methodology
  • Bioanalytical assays
  • Regulatory compliance
  • Method validation
  • Project management
  • Client relationship management
  • Team leadership
  • Technical report writing
  • Employee training
  • Data analysis
  • Cross-functional collaboration
  • Scientific mentorship
  • Process improvement
  • Team building
  • Team management
  • Team building and motivation
  • Culture transformation
  • Innovation management
  • Policy implementation
  • Business strategy
  • Decision-making
  • Staff management

Organizations

  • Active member of AAPS
  • Active member of Global CRO Council

Publications

  • Feb -2022 Bioanalysis Zone : ICH M10 Implementation : global execution and future considerations
  • July - 22022 Land O' Lakes : Bioanalytical Conference- Considérations regarding transfer and cross validation of bioanalytical methods between sites and organizations.
  • Oct – 2021 Global CRO Council : Run Effecency- What is necessary from a compliance standpoint and how to be more efficient in how CRO work. Topics leader
  • Oct- 2021 Global CRO Council : Biomarkers Assay Validation (BAV) BMV or CLIA ? When clinical Biomarker Assay should be performed in a certified clinical lab or bioanalytical lab. Topics Leader
  • Feb – 16 BEBPA- Presenter : Strategies for Development of a Suitable Assay Platform for Detection of Neutralizing Antibodies Induced by Protein Therapeutics
  • May– 11 AAPS-NBC May– 10 AAPS-NBC May– 10 AAPS-NBC May– 10 AAPS-NBC Nov – 02 AAPS-Expo Publications
  • Peptide Therapeutics: Emerging Drugs with Unique Bioanalytical Challenges AAPS News Magazine
  • The development and validation of a Radioligand binding for the Detection of Anti-Insuline Antibodies in Human Serum
  • Validation of a Capture: Elution Electrochemilumenscence Assay to Detect Anti-Drug Antibodies with High Sensitivity and Drug Tolerance
  • Acid Urea Polyacrylamide Gel Electrophoresis: A Completely Denaturing Protocol for the Identification of Multiple A-beta Peptides Within a Single Lane. Acid Urea Polyacrylamide Gel Electrophoresis: A Completely Denaturing Protocol for the Identification of Multiple A-beta Peptides Within a Single Lane.
  • Fryer JD, DeMattos RB, McCormick LM, O’Dell MA, Spinner ML, Bales KR, Paul SM, Sullivan PM, Parsadanian M, Bu G, Holtzman DM, The low density lipoprotein receptor regulates the level of central nervous system human and murine apolipoprotein E but does not modify amyloid plaque pathology in PDAPP mice. J Biol Chem. 2005 Jul 8;280(27):25754-9.Epub 2005 May 11.
  • Morikawa M, Fryer JD, Sullivan PM, Christopher EA, Wahrle SE, DeMattos RB, O’Dell MA , Fagan AM, Lashuel HA, Walz T, Asai K, Holtzman DM, Production and characterization of astrocyte-derived human apolipoprotein E isoforms from immortalized astrocytes and their interactions with Amyloid-beta. Neurobiol Dis. 2005 Jun-Jul;19 (1-2):66-76
  • DeMattos RB, Cirrito JR, Parsadanian M, May PC, O’Dell MA , Taylor JW, Harmony JA, Aranow BJ, Bales KR, Paul SM, Holtzman DM. ApoE and Clusterin Cooperatively Suppress Abeta Levels and Deposition Evidence that Apo E Regulates Extracellular Abeta Metabolism In Vivo. Neuron. 2004 Jan 22;41(2) 193-202.
  • PMID: 14741101 Cirrito JR, May PC, O’Dell MA , Taylor JW, Parsadanian M, Cramer JW, Audia JE, Nissen JS, Bales KR, Paul SM, DeMattos RB, Holtzman DM. In vivo assessment of brain interstitial fluid with microdialysis reveals plaque-associated changes in amyloid-beta metabolism and half-life. J Neurosci. 2003 Oct 1: 23(26):8844-53
  • DeMattos RB, O’Dell MA , Parsadanian M, Taylor JW, Harmony JA, Bales KR, Paul SM, Aranow BJ, Holtzman DM Clusterin promotes amyloid plaque formation and is critical for neuritic toxicity in a mouse model of Alzheimer’s disease. Proc Natl Acad Sci USA 2002 Aug6 : 99(16) 10843-8
  • DeMattos RB, Bales KR, Parsadanian M, O’Dell MA , Foss EM, Paul SM, Holtzman DM Plaque-associated disruption of CSF and plasma amyloid-beta(Abeta) equilibrium in a mouse model of Alzheimer’s disease. J Neurochem. 2002 Apr;81(2)229-36
  • William J. Burke, MD PhD, Vijaya B. Kumar, PhD, Neeraj Pandey, PhD, W. Michael Panneton, PhD, Qi Gan, BS, Mark W. Franko, BS, M ark O’Dell , BS, Shu Wen Li, PhD, Yi Pan, MD, PhD, Hyung D. Chung, MD,and James E. Galvin, MD. Dopamine Metabolite-Induced α-Synuclein Aggregation: Role in Parkinson ’s disease. Annals of Neurobiology

Timeline

Senior Director of Biological Operations

B2S Life Sciences
07.2023 - Current

Associate Director of Lead Scientists for Global iChem Bioanalytical Services

Labcorp drug Development
01.2020 - 07.2023

Associate Director of Bioanalytical Services Indianapolis

Covance
06.2018 - 01.2020

Associate Director, Method Development and Validation

Eurofins
11.2016 - 08.2017

Associate Scientific Director

Eurofins
08.2016 - 06.2018

Laboratory Manager / Site lead for Immunochemistry

Covance
04.2015 - 11.2016

Operations Team Lead, Development / Validation, Senior Scientist

AIT Bioscience, Ligand Binding Assay (LBA) group
05.2013 - 04.2015

Scientist II

Millipore
01.2009 - 01.2011

Operations Team Lead, Development / Validation, Scientist III

EMD Millipore, Discovery & Developmental Solutions
03.2005 - 05.2013

Scientist I

Millipore
03.2005 - 01.2009

Masters of Arts & Science - Biotechnology

Washington University

Bachelor of Arts and Science -

Southern Illinois University

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