AeroLeads people directory · profile

Shawn Roach Email & Phone Number

Senior Consultant, Regulatory CMC at Halloran Consulting Group, Inc.
Location: Denver Metropolitan Area, United States, United States 16 work roles 3 schools
1 work email found @hallorancg.com LinkedIn matched
✓ Verified May 2026 4 data sources Profile completeness 100%

Contact Signals · 1 work email

Work email s****@hallorancg.com
LinkedIn Profile matched
3 free lookups remaining · No credit card
Current company
Halloran Consulting Group, Inc.
Role
Senior Consultant, Regulatory CMC
Location
Denver Metropolitan Area, United States, United States
Company size
78 employees

Who is Shawn Roach? Overview

A concise factual answer block for searchers comparing this professional profile.

Quick answer

Shawn Roach is listed as Senior Consultant, Regulatory CMC at Halloran Consulting Group, Inc., a company with 78 employees, based in Denver Metropolitan Area, United States, United States. AeroLeads shows a work email signal at hallorancg.com and a matched LinkedIn profile for Shawn Roach.

Shawn Roach previously worked as Associate Principal Consultant, Regulatory CMC at Halloran Consulting Group, Inc. and Lead Consultant at Halloran Consulting Group, Inc.. Shawn Roach holds Research Fellow, Biotechnology, Laboratory Automation from Ut Southwestern Medical Center.

Company email context

Email format at Halloran Consulting Group, Inc.

This section adds company-level context without repeating Shawn Roach's masked contact details.

{first_initial}{last}@hallorancg.com
89% confidence

AeroLeads found 1 current-domain work email signal for Shawn Roach. Compare company email patterns before reaching out.

View email format View company profile Management contacts
Profile bio

About Shawn Roach

Experienced biopharmaceutical professional with expertise in Regulatory Affairs and Analytical Chemistry. RAC certified. Regulatory accomplishments include pre-IND, IND and NDA filings as well as post approval support including technology transfer, process validation analytical support plans and Prior Approval Supplement submission. Reviewed and authored CMC sections for IND, NDA and post approval changes. Experienced in managing Contract Analytical Laboratories and Contract Manufacturer relationships. Expertise in industrial problem solving & project leadership. Trained in cGMP manufacturing and validation systems. Minored in German, including coursework in technical GermanDemonstrated expertise in analytical/bioanalytical chemistry including mass spectrometry of oligonucleotides and small molecules, multiple chromatographic separation techniques, high throughput nucleic acid synthesis and laboratory automation.

Listed skills include Hplc, Chromatography, Analytical Chemistry, Gmp, and 24 others.

Current workplace

Shawn Roach's current company

Company context helps verify the profile and gives searchers a useful next step.

Halloran Consulting Group, Inc.
Halloran Consulting Group, Inc.
Senior Consultant, Regulatory CMC
Denver, CO, US
Website
hallorancg.com
Employees
78
AeroLeads page
Company profile
View company profile Email format
16 roles · 37 years

Shawn Roach work experience

A career timeline built from the work history available for this profile.

Director Of Regulatory Affairs

Saint Renatus, Llc

Responsible for creating and managing CMC related regulatory filings to support St. Renatus’ drug product. Duties include developing regulatory strategy for post approval changes, drafting responses to FDA inquiries, assisting with development of Design History File for combination product, managing regulatory submissions, coordinating CMC activities for.

Jan 2016 - Mar 2018

Associate Director, Regulatory Affairs

Clinipace Worldwide

Morrisville, North Carolina, US

Regulatory Project Manager coordinating submissions of pre-IND and pre-NDA meeting briefing packages, IND submissions, ANDA and NDA submissions, and post-submission communications management including annual reports and deficiency responses. Write and review Chemistry, Manufacturing and Controls (CMC) sections of submission packages. Perform CMC gap.

Apr 2012 - Jan 2016

Associate Director, Analytical Chemistry

Opx Biotechnologies, Inc.

Responsible for managing analytical development and support for renewable chemicals research and establishing Quality Systems for the Analytical Group. Responsibilities include: Managed identification of unknown byproducts as well as mass balance and product characterization projects within time and budget constraints. Managed analytical method technology.

Jan 2010 - Apr 2012

Director Of Bioanalytical Chemistry

Dicerna Pharmaceuticals,

Lexington, Massachusetts, US

Responsible for establishment and maintenance of Dicerna’s bioanalytical and analytical laboratory facilities and assays. Responsibilities included: Specified and purchased all equipment and instrumentation including two Acquity UPLC systems, and a triple quadrupole mass spectrometer, lab benches, centrifuges, analytical balances, and all other analytical.

Sep 2008 - Jan 2010

Senior Scientist Ii

Replidyne

US

Responsible for all Analytical Development and Quality Control Chemistry duties to support IND enabling studies of novel antibiotic molecules. Responsibilities included: Supervised and managed two Research Associates. Sourced new analytical chromatography technology and optimized existing analytical methods to meet timing, budget and sensitivity.

Oct 2006 - Jun 2008

Senior Development Scientist

Osi Pharmaceuticals

Method development for LC-MS & MS/MS of therapeutic modified oligonucleotides including identity confirmation, impurity analysis & sequencing. Prepared data & authored reports for inclusion in CMC sections of 2 INDs including managing contacts with external CRO laboratories & evaluating technical reports. Performed LC-MS analysis & data evaluation to.

Apr 2004 - Sep 2006

Oligosynthesis Manager

Ambion Diagnostics

US

Managed implementation of GMP oligonucleotide production facility including authoring SOP, PV and MP documentation, method development and validation for synthesis and purification of oligonucleotides, interfacing with management and customers regarding technical capacity. Hired and managed a team of 4 personnel to validate and produce 114 cGMP compliant.

2003 - 2004 ~1 yr

Project Team Leader & Production Senior Scientist

Proligo

FR

Designed, developed and patented proprietary novel technology for dyeless DNA detection with applications toward microarrays (gene chips) and other high throughput biological analyses Researched new technologies and alpha tested novel nucleic acid chemistry reagents including: synthesis methods development and analysis of promising compoundsresearched.

Oct 2000 - Jan 2003

Chemist

Air Products

Allentown, Pennsylvania, US

1990 - 1992 ~2 yrs

Chemist

Basf

Ludwigshafen, DE

1989 - 1990 ~1 yr
Team & coworkers

Colleagues at Halloran Consulting Group, Inc.

Other employees you can reach at hallorancg.com. View company contacts for 78 employees →

DC Daniel C. Daniel C. Colleague at Halloran Consulting Group, Inc. Wakefield, Massachusetts, United States, United States View → GJ Genna Jenkins Genna Jenkins Colleague at Halloran Consulting Group, Inc. Oakley, Kansas, United States, United States View → EM Eric Moss Eric Moss Colleague at Halloran Consulting Group, Inc. House Springs, Missouri, United States, United States View → BB Bonnie Bonniesh Bonnie Bonniesh Colleague at Halloran Consulting Group, Inc. Nairobi, Nairobi County, Kenya, Kenya View → PV Pamela Vizanko Pamela Vizanko Colleague at Halloran Consulting Group, Inc. San Diego Metropolitan Area, United States View → DS Doug Shaw Doug Shaw Colleague at Halloran Consulting Group, Inc. Arnold, Maryland, United States, United States View → HB Hema Balasubramanian Hema Balasubramanian Colleague at Halloran Consulting Group, Inc. New York, New York, United States, United States View → BH Bridget Hindman Bridget Hindman Colleague at Halloran Consulting Group, Inc. Mesquite, Texas, United States, United States View → MH Matthew Houck Matthew Houck Colleague at Halloran Consulting Group, Inc. Durham, North Carolina, United States, United States View → YD Yasmin Dora Yasmin Dora Colleague at Halloran Consulting Group, Inc. The Randstad, Netherlands, Netherlands View →
3 education records

Shawn Roach education

Research Fellow, Biotechnology, Laboratory Automation

Ut Southwestern Medical Center

Ph.D., Analytical Chemistry

The University Of Texas At Dallas

Bs, Chemistry

Texas Tech University
FAQ

Frequently asked questions about Shawn Roach

Quick answers generated from the profile data available on this page.

What company does Shawn Roach work for?

Shawn Roach works for Halloran Consulting Group, Inc..

What is Shawn Roach's role at Halloran Consulting Group, Inc.?

Shawn Roach is listed as Senior Consultant, Regulatory CMC at Halloran Consulting Group, Inc..

What is Shawn Roach's email address?

AeroLeads has found 1 work email signal at @hallorancg.com for Shawn Roach at Halloran Consulting Group, Inc..

Where is Shawn Roach based?

Shawn Roach is based in Denver Metropolitan Area, United States, United States while working with Halloran Consulting Group, Inc..

What companies has Shawn Roach worked for?

Shawn Roach has worked for Halloran Consulting Group, Inc., Saint Renatus, Llc, Clinipace Worldwide, Opx Biotechnologies, Inc., and Dicerna Pharmaceuticals,.

Who are Shawn Roach's colleagues at Halloran Consulting Group, Inc.?

Shawn Roach's colleagues at Halloran Consulting Group, Inc. include Daniel C., Genna Jenkins, Eric Moss, Bonnie Bonniesh, and Pamela Vizanko.

How can I contact Shawn Roach?

You can use AeroLeads to view verified contact signals for Shawn Roach at Halloran Consulting Group, Inc., including work email, phone, and LinkedIn data when available.

What schools did Shawn Roach attend?

Shawn Roach holds Research Fellow, Biotechnology, Laboratory Automation from Ut Southwestern Medical Center.

What skills is Shawn Roach known for?

Shawn Roach is listed with skills including Hplc, Chromatography, Analytical Chemistry, Gmp, Lc Ms, Regulatory Affairs, Validation, and Chemistry.

Find 750M verified contacts

Search by job title, company, industry, location, and seniority. Export verified B2B contact data when you need it.