John Bartell Email & Phone Number

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

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.

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.

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

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.

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

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

➢ 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

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

Bachelor Of Applied Science - Basc, Chemistry

Phd, Biochemistry And Molecular Biology