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

Democratizing access to high purity mRNA, from concept to clinical trials.

Chief Scientific Officer and Founder

Chief Executive Officer & Founder

Omega Therapeutics

Head of platform biology, process development, analytical sciences, & drug formulation & delivery
Leading CMC & supply chain (mRNA & lipid nanoparticles)
Advancing novel targets through platform feasibility
Supporting business development & strategy

VP, Process Development & Manufacturing

Translate Bio

Head of mRNA discovery & mRNA process development group, platform biology, & data sciences
Designed novel mRNAs, including fusion proteins, I/O targets, & in silico engineered proteins
Immuno oncology: identified targets, led research including in vitro and in vivo proof-of-concept studies
Primary ciliary dyskinesia: cross-functional project leader to in vivo
Initiated & managed external platform-supporting projects with academic labs
Scientific lead on business development campaigns

Senior Director, Research Discovery & Process Development

CRISPR Therapeutics

Director, Collaborative Research

Arcturus Therapeutics

Led mRNA drug discovery, platform and process development for internal pipeline and partnered programs
Resourced and managed research lab which supports programs and platform through mRNA design and synthesis, protein assay development, in vitro and in vivo studies, bioanalysis, quality systems
Served as Arcturus-Ultragenyx Research Head (Research Team Leader, Joint Steering Committee member)
Identified and proposed target opportunities for internal/ partner pipeline; novel uses for mRNA as gene transfer platform
Collaborated to propose, initiate, design research, define success criteria, and lead mRNA programs into the clinic

Director of Drug Discovery

Discovery Strategies

Harmonizing research, developmental, and commercialization strategies
Basic and platform research
Candidate selection research, including in vitro and in vivo pharmacology
Non-clinical (IND-enabling) and FIH development
Project and alliance management

Consultant

Alexion Pharmaceuticals, Inc.

Molecular Biology: mRNA platform development, design and engineering
Discovery program manager: planning and coordinating candidate selection research (biochemistry, cell, preclinical), non-clinical & clinical development, regulatory
Delivery technology, including lipid nanoparticles
Management of scientific staff, cross functional teams, and external research
Lab startup

Research Scientist II, RNA Therapeutics Unit

Manage lab that plans and executes research to support pre-clinical development for protein therapeutics
Set objectives and timelines for staff and supporting researchers to drive early stage discovery for programs in multiple therapeutic areas
Design and develop assay methods using a variety of technologies to support screening cascades

Staff Scientist

KaloBios

Research of novel antibody humanization strategies to drive efficiencies and IP positions
Develop PoC for proprietary epitope targeting technology
Bacterial expression of antibody fragments and antigen, basic protein chemistry

Scientist

Experienced in LNP-mRNA process technologies, manufacturing, quality, and regulatory interactions.

Leadership in pre-clinical research for candidate selection & non-clinical development across many therapeutic platforms.  Able to identify targets and discovery cascades in various therapeutic areas and organ systems.  Skilled at identifying external drug, technology, and platform assets.  Accomplished at designing experimental cascades, building and leading teams of scientists & stakeholders to drive early stage discovery to clinical endpoints.  Versatile scientific manager, able to identify essential questions to streamline R&D geared for commercial and intellectual property success.

Specialties:
Assay development for gene editing, cellular & in vivo pharmacology, process development & CMC
RNA, gene editing (CRISPR/Cas, TALENS), small molecule, & monoclonal antibodies therapeutics
R&D: drug discovery, IND-enabling, & platform development
Target concept ID to first-in-human
Research externalization, CRO & academic management
Molecular engineering of therapeutic proteins and mRNA
Phage display and protein engineering
Development of discovery cascades & novel screening technologies


Christian Cobaugh

This is a great opportunity to the Genetics Medicines business unit at Alloy Therapeutics, Inc. which is one of our fastest growing units. We are looking for a motivated business development leader who can help bring our technology and gen-med related services to more partners and customers.  Now is a great time to join our team!

Democratizing access to foundational biologics discovery technologies & services

Waltham, Massachusetts, United States (On-site)

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Judith Adair McCorry

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