Apex Compliance Solutions

As CEO of Apex Compliance Solutions, I am dedicated to driving strategic vision, fostering innovation, and cultivating a culture of excellence within our organization. With a focus on delivering unparalleled value to our clients and stakeholders, I lead our talented team in achieving ambitious goals and propelling the company forward. Through effective leadership, collaboration, and a relentless commitment to quality, we are shaping the future of compliance solutions and empowering businesses to thrive in a dynamic regulatory landscape.

Chief Executive Officer

University of Vermont Grossman School of Business

As a member of the advisory board for Women in Leadership Program at Grossman School of Business I have the opportunity to evaluate coursework and advocate for women in different organizations.

Advisor

Vernal Biosciences

Responsible for building and qualifying early phase to commercial quality and operations. Recruit a high-performing team capable of manufacturing and testing high-quality LNP-mRNA for third-party clients.

Senior Vice President, GMP Operations

Recruit talented individuals for Quality Control, Validation, and Quality Systems and continue to build a quality culture focused on collaboration and transparency. 
Implement cloud based quality management system with a focus on risk-based quality to support phase appropriate guidelines for GMP manufacturing.

Senior Vice President of Quality 

ETI Capital

Works to ensure a robust leadership culture exists; aligning strategic goals with leadership behaviors. Providing a unified approach for the consistency of company culture, among them corporate purpose and values and the equity and inclusion strategy. Provides training and coaching on the fundamental basics of valued leadership traits from executive team to individual contributors.

Board Member

1st Detachment Nutrition

Work closely with the CEO to develop strategy for the company, not limited to the company's mission, vision, and culture. Has a deep understanding of the business to optimize and expand target market segments of the nutritional industry. Along with a strong background in leadership and quality, is also able to assist in product development and marketing.

Board member 

Vibalogics

Built a talented Quality team of over 22 individuals in the span of 1 year, including Quality Assurance, Quality Management Systems, and Quality Control. Installed a cloud based quality management system and prepared the site for GMP manufacturing. Implemented strategies to accomplish the company's quality and compliance goals and partnering with key stakeholders to meet regulatory expectations and requirements for phase appropriate manufacturing as a CDMO.

Vice President Of Quality

Emergent BioSolutions

Provided Quality oversight and direction for the Bayview quality compliance and quality operations functions to ensure patient safety and compliance with FDA and other applicable health authority requirements. Provided strategic planning for continuous improvement and reporting/escalation of quality issues and risk mitigation activities. Ensured a culture of quality and compliance through effective leadership and strict adherence to Emergent's core values.

Director Of Quality Assurance

Merck

Lead Quality team in support of culture media, black widow spider antivenin and weigh & dispense operations ▪ Collaborate with technology operations on process improvements including single use mixers and third party manufacturing of media and buffers ▪ Approver of investigations and deviations .

Associate Director, IPT Quality Lead

Responsible for the management, training & development of incoming materials quality specialists ▪ Collaborate with shipping, receiving and logistics to support multiple products site wide ▪ Approver of investigations and change control

Interim IPT Quality Lead, Incoming Materials

Responsible for the management and training of quality operations support staff to sterile
supply ▪ Collaborate with technology and operations for continuous improvement activities
involving safety and compliance ▪Lead Sterile Supply in internal and external regulatory audits

Interim IPT Quality Lead, Sterile Supply

Train and oversee support staff of 100 within Operations and Quality Associates on regulatory compliance ▪ Collaborate with Operations and Technology Operations in improving current and new processes ▪ Perform quality audits for site supply of sterile processing equipment ▪ Review SOP’s, Change Control Reports, Corrective and Preventative Actions, Continuing Validation Protocols and Final Reports

Senior Specialist, Quality Operations

Independently worked on capital projects, change requests, and deviation investigations ▪ Managed product transfers, technology transfer, and implementation of single use mixing technology ▪ Led closeout of major critical investigations with product impact ▪ Met critical timelines as part of collaboration with Manufacturing Operations and Laboratory Testing ▪ Supported manufacture of Culture Media used in downstream vaccine franchises

Tech Services Specialist/ Engineer

Leading Apex Compliance Solutions with a strategic vision, my tenure as CEO is marked by spearheading innovative practices and fostering a culture committed to excellence. Our focus on delivering top-tier compliance solutions is propelled by quality assurance expertise, ensuring our clients navigate the dynamic regulatory landscape successfully.

Previously, as SVP at Vernal Biosciences, my leadership was instrumental in establishing robust GMP operations and assembling a high-caliber team. The collaboration and quality-driven mindset we cultivated are the cornerstones of my mission to empower businesses and advance industry standards in compliance.

Judith Adair McCorry

IGM Biosciences, Inc.

In vivo functional lead to develop 4-1BB T-cell agonist program 
Test proof of concept IgG and IgM antibodies using in vitro and in vivo efficacy tumor models
- Designed the in vivo study plan to assess in vivo efficacy, PD biomarker, and PK assessment
- Collaborated with  in vivo pharmacology team to execute the in vivo studies
- Established in vitro functional assays Binding, T-cell activation, TDCC, ADCP, testing proof of concept IgG and IgM and drug candidate antibodies using human PBMC and mouse ex vivo immune cells
- Developed a phopsho-Flow assay as part of assay development for secondary screening assay

Scientist III

BMC infectious diseases

As an Editorial Board Member, I play a pivotal role in assessing manuscripts for publication, by guiding them through the peer-review process. 
Specifically my role is responsible for selecting peer reviewers, and then 
recommending publication decisions on the basis of the peer review reports assessment.

Associate Editor

Sanofi Pasteur

- Played active role in building relationships with the academic community and lead academic collaboration for mRNA vaccine studies
- Optimize, and screen next-generation mRNA-based vaccines against influenza.
- Safety and immunogenicity assessment of novel mRNA-based adjuvant formulations
- Manage multiple external CROs to perform pre-clinical studies using mouse, and non-human primate models
- Prepare documents and presentations, contribute to briefing and communications materials
- Implemented a new up and running exploratory immunology team of 4 direct reports to drive research delineating the Immunogenicity and reactogenicity pathways of mRNA vaccine
- Served on cross-functional project teams as the in vivo expert and fostered a scientific culture of collaboration to study pre-clinical animal models to advance a collection of early-stage programs in pursuit of pre-clinical proof of concept studies and to support IND-enabling studies
- Served as IACUC PI and worked with lab management to draft and submit appropriate protocols for IACUC approvals
- Managed over $2-3 million of budget for establishment of lab and preclinical studies
- Use of human whole blood and PBMCs in invitro assays
Highly skilled in database, record, and inventory management (Trained with Benchling)

Senior Scientist

BMC molecular and cell biology

As an associate editor, I play a pivotal role in assessing manuscripts for publication, by guiding them through the peer-review process. 
Specifically my role is responsible for selecting peer reviewers, and then 
recommending publication decisions on the basis of the peer-review report assessment.

St. Jude Children's Research Hospital

- Lead the development and characterization of universal influenza HA vaccine candidate employing whole in-activated virus and mRNA modalities
- Identified several point mutations that influence the HA stability of influenza viruses
- Employed reverse genetics to generate influenza HA vaccine strains with stability mutations (COBRA-Ag) and collaborated with the University of Georgia and University of Pennsylvania
- Carried in vivo preclinical studies to evaluate effect of HA stability mutants using small animal mice models and ferret-transmission study
- Skillful at communication of scientific and technical information to both scientific and non-scientific groups 
- Developed research methodologies and drafted SOPs to have reproducible and accurate results
- Provided mentorship to intra and inter-departmental colleagues (Scientists, Associate scientists, graduate students, postdocs, RA, and technical staff)

Lead Researcher

- Successfully demonstrated the role of innate immune signaling pathways in infectious, autoimmune diseases and carcinogenesis mouse models
 - Played crucial role in identification of cytokine mediated immunological cell death in SARS-CoV2 and revealed blockage of TNF and IFNgamma could ameliorate Covid disease state
 - Identified ZBP1 as innate sensor to mediate uniformed form of multiple cell death process termed PANoptosis to bacteria, virus and fungus infection
 - In an autoinflammatory mouse model Pstpip2cmo, we showed SYK kinase is responsible for the production of inflammatory IL-1b that drives the disease phenotype

Postdoctoral Scientist

Cedars Sinai Medical Center

- Unraveled the assembly and activation of the NLRP3 inflammasome complex at mitochondria and its functional role in Cryopyrinopathies
- Contributed to the identification of NLRP12 to potentiate the recruitment of immune cells to the site of infection via the expression of chemokine KC/CXCL1 during Influenza infection

Post Doctoral Scientist

An innovative and experienced Immunology Senior Scientist specialized in inflammation, infectious diseases, immuno-oncology, and vaccinology. With over 13 years of combined academia and industry experience, I have led discovery and research projects in mRNA vaccines, immuno-oncology, and infectious disease therapeutics.

I am proficient in designing and implementing novel mRNA-based vaccines for Influenza-A virus, Antibody biologics targeting T-cells, and Auto-inflammatory disorders. My expertise extends to managing in-vitro, ex-vivo, and in-vivo preclinical studies using primary cells, mice, ferret, and non-human primate models.

As a project lead for mRNA vaccines, I successfully managed and mentored a team to support IND-enabling studies. My leadership qualities include fostering a culture of teamwork and a CAN DO - WILL DO attitude, driving exceptional quality research.

Key competencies include:

Developing and mentoring scientists in cellular and mouse models for immunology studies
Expertise in immunogenicity and reactogenicity assessment of Therapeutic and vaccine candidates using in vitro and in vivo models
Strong leadership in managing exploratory research projects, understanding mechanisms of action, and supporting IND filings
I have a proven track record of impactful research contributions, including identifying novel innate immune signaling pathways and playing a pivotal role in the development of universal influenza vaccine candidates.

taplio

The Battle

Judith Adair McCorry

Balaji Banoth Ph.D.

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