Andre Pearson
CEO and Founder at BIOTECH GENERICS LLC | New York City Metropolitan Area
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As the CEO and Founder of BIOTECH GENERICS LLC, Andre Pearson leverages his extensive expertise in Chemistry, Manufacturing, and Controls (CMC) to drive innovative product strategies and lifecycle management initiatives. With a robust background in regulatory affairs, Andre has become a pivotal resource for cross-functional teams, providing guidance on complex regulatory-related product development issues. His leadership in negotiating with global regulatory authorities has been instrumental in advancing key programs that significantly impact the business, ensuring compliance while fostering innovation.
Under Andre's stewardship, BIOTECH GENERICS has successfully navigated the intricacies of IND, NDA, ANDA, and 505(b)(2) submissions, demonstrating his proficiency in eCTD documentation and post-marketing applications. His experience encompasses a diverse portfolio of biopharmaceutical products, including MACI® and Carticel®, both autologous cultured chondrocyte therapies, as well as the antibacterial agent CUBICIN® and the antiemetic Zuplenz®. Currently, Andre is overseeing the development of CB-315, a promising candidate in Phase III clinical trials, further solidifying his commitment to advancing life sciences.
Andre's technical writing skills shine through in the preparation of stability reports and regulatory submissions, ensuring that all documentation meets the highest standards of quality and compliance. His expertise in technology transfer and validation processes has been crucial in facilitating successful product launches and enhancing operational efficiencies. With a deep understanding of organic chemistry and biopharmaceuticals, Andre Pearson continues to position BIOTECH GENERICS LLC at the forefront of the industry, driving growth and innovation in a rapidly evolving landscape.
CEO and Founder at BIOTECH GENERICS LLC in January 2010 to Present
CEO and Founder at BIOTECH GENERICS LLC in August 2010 to Present
Senior CMC Regulatory Affairs Specialist at Ipsen Biopharmaceuticals in December 2012 to Present
Medical Regulatory Affairs Senior Writer (remote) at MakroCare in January 2014 to Present
Regulatory Affairs Manager with PharmaLex USA at PharmaLex in September 2015 to Present
REGULATORY CMC MANAGER and SENIOR MEDICAL WRITER at Merck in September 2015 to Present
CMC and Medical Writer at INDIVIOR, Inc. at Indivior in January 2017 to Present
Principal Medical Writer and CMC Scientist at Mitsubishi Tanabe Pharma America at Mitsubishi Tanabe Pharma America in January 2018 to Present
Principal Medical Writer and CMC Scientist at Mitsubishi Tanabe Pharma America in January 2018 to Present
Project Manager at Celgene in April 2018 to Present
Principal Medical Regulatory Writer & CMC Scientist Senior Manger at University of Pennsylvania (Gill Laboratory) in April 2020 to Present
Eli Lilly Global Communications Principle Medical Writer at Eli Lilly - IMCLONE in August 2013 to February 2014
Senior Technical Writer at MonoSol Rx in September 2012 to November 2012
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Biotechnology
Pharmaceutical Industry
Product Launch
Vaccines
Infection
Generic Programming
Antibacterial
Pharmaceutical Sales
Regulatory Affairs
Lifesciences
GMP
Oncology
Technology Transfer
Market Access
Pharmaceutics
Medical Devices
Sales Effectiveness
Clinical Trials
Validation
ANDAs
CRO
Organic Chemistry
Analytical Chemistry
Sop
Clinical Development
FDA
Regulatory Submissions
Chemistry
SOP
Biopharmaceuticals
Drug Development
Life Sciences
IND
Quality Assurance
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What is Andre Pearson email address?
Email Andre Pearson at [email protected] and [email protected]. This email is the most updated Andre Pearson email found in 2026.
What is Andre Pearson phone number?
Andre Pearson phone number is +17819222759 and +16172836836.
How to contact Andre Pearson?
To contact Andre Pearson send an email to [email protected] or [email protected]. If you want to call Andre Pearson try calling on +17819222759 and +16172836836. (updated on October 30, 2024)
What is Andre Pearson net worth?
Andre Pearson has an estimated net worth of $150,000 to $249,999
What company does Andre Pearson work for?
Andre Pearson works for BIOTECH GENERICS LLC
What is Andre Pearson's role at BIOTECH GENERICS LLC?
Andre Pearson is CEO and Founder
What industry does Andre Pearson work in?
Andre Pearson works in the Pharmaceutical Manufacturing industry.
Andre Pearson Email Addresses
Andre Pearson Phone Numbers
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