John Bartell

John Bartell Email and Phone Number

Microbiology Leader | Aseptic Manufacturing Microbiology | Community Growth | Writer | Past Non-Profit President | Leading non-profit & science organizations to foster connections & advance pharma development @
John Bartell's Location
Aledo, Texas, United States, United States
About John Bartell

As a Senior Microbiology Executive, I have spent over 20 years developing innovative molecular and microbiology processes while driving aseptic project production and patient safety for global consumers. I have been fortunate enough to contribute to many functions of the pharmaceutical R&D project pipeline within big pharma and BioTech. My superpowers include motivating Analytical Chemistry, Consumer Product, and Anti-infective Microbiology teams to produce quality deliverables tied to microbiology release testing, microbiology in-process, microbiology method development, technical writing, microbiology test reporting and review, Good Manufacturing Practices (GMP), regulatory compliance, and pharmaceutical process development.Over the years, I have found my niche to be creating value in organizations by leveraging my GxP acumen to lead pharmaceutical pipeline development efforts that deploy products to market faster and build regulatory agency trust. I am seeking Senior Director of Microbiology roles that allow my leadership to directly impact patient safety, pharmaceutical product portfolio growth, and scientific team development.Career Wins* Established and managed a state-of-the-art molecular microbial analysis laboratory for Alcon anti- infective products, enhancing product positioning with superior label claims.* Led cross-functional team from pre-clinical to Phase II initiation for ocular anti-viral project.* Oversaw a consumer product microbiology lab and facilitated the successful rollout of a leading contact lens solution.I’m also passionate about serving two community non-profit organizations - the DFW Writers’ Workshop and the Fort Worth Poetry Society. In my four years as president of the DFW Writers’ Workshop, a 150 member strong writing community with a significant budget, I promoted healing and inclusiveness to ensure our organization’s foundation, its bylaws, were updated in a way that strengthened us. There were many other challenges - COVID protocols, bringing tech to our community, and ensuring our annual conference, voted the best writers’ conference in Texas, had excellent leadership and continued its amazing tradition of writers helping writers. Specialties: ➢ Laboratory Leadership/Management➢ Project Team Leadership➢ Pharmaceutical Product Pipeline Expertise➢ Aseptic Drug Product Manufacturing ➢ New Technology Assessment ➢ Molecular Biology/Microbiology Techniques ➢ Method Development➢ Resource Planning➢ Staff Development and Mentoring➢ Service Lab Marketing and Business Development

John Bartell's Current Company Details
Bartell Pharma Consultant, LLC

Bartell Pharma Consultant, Llc

Microbiology Leader | Aseptic Manufacturing Microbiology | Community Growth | Writer | Past Non-Profit President | Leading non-profit & science organizations to foster connections & advance pharma development
John Bartell Work Experience Details
  • Bartell Pharma Consultant, Llc
    Microbiology Consultant
    Bartell Pharma Consultant, Llc Aug 2024 - Present
    Fort Worth, Texas, United States
    Microbiology consultant with over 20 years of experience in pharmaceutical drug product and medical device development. • Subject Matter Expertise in: sterility testing, bioburden testing, antimicrobial efficacy testing, method suitability, microbial analysis, quality investigations, corrective and preventative actions, and microbial molecular analysis.• Microbiology Testing: protocol authoring/review, testing report authoring/review, Batch Record review and approval - ensuring… Show more Microbiology consultant with over 20 years of experience in pharmaceutical drug product and medical device development. • Subject Matter Expertise in: sterility testing, bioburden testing, antimicrobial efficacy testing, method suitability, microbial analysis, quality investigations, corrective and preventative actions, and microbial molecular analysis.• Microbiology Testing: protocol authoring/review, testing report authoring/review, Batch Record review and approval - ensuring compliance with applicable requirements. • Microbiology Methods: Advisement on test method development, method suitability development. • GxP Quality Assurance: Quality investigations, conducting audits, data/batch record review, developing SOPs, and providing training to ensure adherence to regulatory standards.• Regulatory filing: Microbiology section compilation/review. Show less
  • Novartis
    Analytical Manufacturing Support Lead | Aseptic Microbiology Sme | Analytical Chemistry Liaison
    Novartis Jan 2022 - Jan 2024
    Fort Worth, Texas, United States
    Coordinated and ensured on-time and GMP compliant testing (release and in-process) to support over 20 aseptic clinical supply manufacturing campaigns.• Subject Matter Expert (SME) charged with reviewing and aligning specifications and test results. Includes In-Process Controls (IPC), release and deviation handling.• Coordinated cleaning validations and verifications, ensuring no delay based on cleaning requirements for manufacturing campaigns.
  • Novartis
    Microbiology Project Lead | Project Management | Microbiology Sme | Quality Assurance
    Novartis Jun 2017 - Jan 2024
    Fort Worth, Texas, United States
    Provided technical leadership on core teams with overall responsibility for resource planning, development of technical documents, supporting regulatory filings, and achieving milestones for assigned project teams.
  • Novartis
    Operations Team Lead, Pharma | Associate Development |
    Novartis Apr 2020 - Apr 2022
    Fort Worth, Texas, United States
    Led a team of 7 analytical chemists supporting drug product development. Responsible for planning and organizing work, providing adequate staffing and resources, and maintaining work on schedule to meet project timelines.• Ensured GxP compliance in all areas of project support – no major audit findings or project delays due to compliance.• Drove the planning, coordination, and execution of all people management processes for a team of scientists, including performance management… Show more Led a team of 7 analytical chemists supporting drug product development. Responsible for planning and organizing work, providing adequate staffing and resources, and maintaining work on schedule to meet project timelines.• Ensured GxP compliance in all areas of project support – no major audit findings or project delays due to compliance.• Drove the planning, coordination, and execution of all people management processes for a team of scientists, including performance management, training, and development planning.• Identified and devised unit training opportunities, addressing both strategic and behavioral needs while taking into account suitable metrics to quantify training success. Drive a culture of excellence in knowledge sharing.• In close cooperation with the Analytical Chemistry Group Head, drive the unit long-term strategic plan and its implementation. Show less
  • Dfw Writers' Workshop
    President
    Dfw Writers' Workshop Apr 2014 - Jan 2024
    Euless, Texas, United States
    * Provided leadership for a 150 member community based non-profit* Served as president for 4 years - lead the community out of COVID restrictions, drove bylaw updates, meeting venue upgrades.* As president ensured that leadership was in place for a 400 attendee writer's conference.* Served the Workshop in other leadership positions.
  • Alcon Labs
    Microbiology Project Lead
    Alcon Labs Oct 2014 - May 2017
    Dallas/Fort Worth Area
    ➢ Provide technical leadership on core teams with overall responsibility for resource planning, development of technical documents, supporting regulatory filings, and achieving milestones for assigned project teams. ➢ Develops efficient project plans to identify potential scientific challenges and are designed to achieve milestone targets and global regulatory requirements. ➢ Serves as the technical expert in field by providing guidance and expertise to help others reach effective… Show more ➢ Provide technical leadership on core teams with overall responsibility for resource planning, development of technical documents, supporting regulatory filings, and achieving milestones for assigned project teams. ➢ Develops efficient project plans to identify potential scientific challenges and are designed to achieve milestone targets and global regulatory requirements. ➢ Serves as the technical expert in field by providing guidance and expertise to help others reach effective solutions.➢ Identifies resources, communicates and collaborates cross functionality to achieve high quality decisions. ➢ Compiles, analyzes, and presents data and results to project teams and management. ➢ Acts as the Microbiology liaison regarding all regulatory activities for assigned projects. ➢ Interfaces with laboratory managers to ensure appropriate support to meet project objectives. ➢ Oversight of all Pharmaceutical projects and Pharmaceutical project leads. Show less
  • Alcon Labs
    Assistant Director Vision Care Microbiology
    Alcon Labs Mar 2012 - Oct 2014
    Ft Worth Tx
    ➢ Lead microbiology laboratory responsible for efficacy testing for contact lens solutions and systems.➢ Responsibilities included technical leadership, resource planning, personnel management, professional development of direct reports.➢ Provided supporting data for anti-infective and contact lens solution projects (spanning Development, Research and Manufacturing).➢ Collaborated with key stakeholders to develop testing timelines and milestones.➢ Contributed to project… Show more ➢ Lead microbiology laboratory responsible for efficacy testing for contact lens solutions and systems.➢ Responsibilities included technical leadership, resource planning, personnel management, professional development of direct reports.➢ Provided supporting data for anti-infective and contact lens solution projects (spanning Development, Research and Manufacturing).➢ Collaborated with key stakeholders to develop testing timelines and milestones.➢ Contributed to project development activities as a subject matter expert.➢ Ensured laboratory personnel followed quality guidelines in all testing procedures and documentation practices. ➢ Seven direct reports. Show less
  • Alcon Laboratories, Inc.
    Assistant Director Clinical Microbiolgy
    Alcon Laboratories, Inc. 2001 - 2009
    ➢ Leads a team of scientists in support of anti-infective product development through microbial identification and antibiotic susceptibility characterization. ➢ Supports microbial characterization for other Microbiology groups within Alcon. ➢ Ongoing efforts to develop detection, identification and quantification methods for viral clinical trial support, a new field for Alcon. ➢ Works closely with the clinical group to track the success of new methodology. ➢ Directed a $2M… Show more ➢ Leads a team of scientists in support of anti-infective product development through microbial identification and antibiotic susceptibility characterization. ➢ Supports microbial characterization for other Microbiology groups within Alcon. ➢ Ongoing efforts to develop detection, identification and quantification methods for viral clinical trial support, a new field for Alcon. ➢ Works closely with the clinical group to track the success of new methodology. ➢ Directed a $2M research contract with an outside vendor to develop recombinant formulation excipients.➢ Identified and employed methods for fungal strain tracking in efforts to investigate sources of contamination. ➢ Responsible for maintenance of the Alcon Culture Collection.➢ Engaged in team member mentoring and career development.➢ Responsible for resource allocation planning.➢ Microbiology representative on multi-functional teams charged with drug development. Show less
  • Midi Labs
    Laboratory Manager
    Midi Labs 1996 - 2001
    Newark De
    Managed daily operations of the first DNA sequencing lab to provide microbial identifications utilizing the MicroSeq system. Directed marketing and business development. Provided continuous improvement to the MicroSeq product by identifying and addressing gaps in microbial identification libraries and software.I started as a Data Analyst at MIDI Labs. as such I provided support for the development of the MicroSeq microbial identification system through DNA sequence analysis… Show more Managed daily operations of the first DNA sequencing lab to provide microbial identifications utilizing the MicroSeq system. Directed marketing and business development. Provided continuous improvement to the MicroSeq product by identifying and addressing gaps in microbial identification libraries and software.I started as a Data Analyst at MIDI Labs. as such I provided support for the development of the MicroSeq microbial identification system through DNA sequence analysis, software evaluation and sequence annotation and validation. Evaluated the taxonomy and nomenclature gene sequence for inclusion on the MicroSeq software. I also developed standards for interpreting 16S rRNA comparative sequence analysis. Performed typical molecular biology techniques (PCR, sequencing, etc). Show less

John Bartell Education Details

Frequently Asked Questions about John Bartell

What company does John Bartell work for?

John Bartell works for Bartell Pharma Consultant, Llc

What is John Bartell's role at the current company?

John Bartell's current role is Microbiology Leader | Aseptic Manufacturing Microbiology | Community Growth | Writer | Past Non-Profit President | Leading non-profit & science organizations to foster connections & advance pharma development.

What schools did John Bartell attend?

John Bartell attended Frostburg State University, University Of South Carolina.

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