Estela Alvarez, Ph.D.

Cell: (650)759-1568  E-mail:

Professional Summary

Organic chemist with over 25 years of experience in quality (QA and QC), project management, manufacturing, and regulatory filings such as Investigational New Drug Application (IND), New Drug Application (NDA) and fillings with FDA and the European Agency for the Evaluation of Medical Products (EMEA). Provided strategic manufacturing and quality planning for supporting global supply of clinical (phase I/III) and commercial products. Conducted quality audit and provided training in current Good Manufacturing Practices (cGMP) and specific quality control methods and operations.

Provided instruction in Chemistry to undergraduate students and junior college students. Native speaker in Spanish and Intermediate in French


• Successfully launched three pharmaceutical products from Phase II/ III to the market. • Wrote and reviewed numerous Standard Operating Procedures, Work Instructions and Forms for companies in phases I/III

• Wrote dozens of characterization reports, development reports, and method validation reports.

• Conducted over 100 GMP audits identified critical compliance gaps. Successfully collaborated with vendors and suppliers to address them.

Areas of Expertise

Active Pharmaceutical Ingredients (API)/Class Dosage Form Systems and Operations
Small molecules Parenteral Quality systems

• Change Control

• Deviations


• Training

• Internal and External audits

• Quality Agreements

• Vendor Management

• Investigations

• Electronic Document Management systems

Polymers Topical
Peptides Oral
Proteins Transdermal (patch)
Oligonucleotides Aerosols Laboratory operations

• Method development

• Method validation

• Method Transfer

• Reference Standard Program

• Stability program

• API and Impurity characterization • Equipment qualification

• Environmental Program

Monoclonal antibodies

Professional Experience (Pharmaceutical and Biotech)

EA CMC Consulting (September 2022-present)


Provided technical guidance to pharmaceutical development partners regarding characterization of degradation products, and extractable and leachable compounds. Proposed analytical methods to identify and quantify degradation products. Prepared and implemented policies and standard operating procedures in alignment with regulatory expectations. Conducted audit of suppliers of raw materials, drug substances, drug product, as well as packaging and labeling of clinical trial materials.

System Administrator for Quality documents providing process improvements via configuration changes, testing, and implementation of system changes.

Eicos Sciences Inc. San Mateo CA, December 2020-present

VP of Quality and Analytical Development

Neurona Therapeutics Inc. South San Francisco CA, August 2019-November 2020 VP of Quality Control and Quality Assurance.

Relypsa, Inc. Redwood City CA, September 2013-August 2019

VP, Quality and Analytical Development

Genentech, Inc. South San Francisco CA, June 2013-September 2013

Senior Quality Pharmaceutical Leader

Affymax, Inc. Palo Alto CA, June 2006-June 2013

Executive Director, Quality Control and Analytical Development, 2012-2013 Senior Director Quality Control and Analytical Development, 2006-2011

Vaxgen, Inc. South San Francisco CA, May 2003- May 2006

Director, Quality Control: May 2004- June 2006

Associate Director, Quality Control: April 2003-April 2004

Sugen, Inc. South San Francisco CA, January 2002-April 2003

Group Leader, Quality and Analytical Development

Lynx Therapeutics (currently llumina). Hayward CA, January1999-January 2002 Quality Manager (QC and QA).

Teaching Experience

Solano Community College, Fairfield CA, 2022-2023

Provided instruction in Chemistry to first year students


Post-doctoral Fellow. National Institutes of Health, NCI. Bethesda MD

Ph.D. Chemistry, University of Maryland, College Park MD

MS. Chemistry, The American University, Washington DC

BS. Chemistry, Iberoamerican University, Mexico City


EA CMC Consulting will align with your company goals and will provide solutions in every stage of the drug lifecycle from preclinical to launching your pharmaceutical product

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