Emily Sciortino

Accomplished biopharmaceutical analytical development and quality control leader with 15 years’ experience driving end to end analytical control strategy, method development, validation and regulatory submission activities for biologics. Extensive experience overseeing CMC analytical work across early and late-stage development for various modalities including monoclonal antibodies, complex fusion proteins and bispecifics. Well-versed with internal and external global QC network management, including CDMO and CLO relationships, method/technology transfers, and ensuring GxP compliance. My passion is transforming drug development using automation tools and platform methodologies to support efficient, high-quality analytical execution.

What I Do

Chemist & Biochemist

Deep expertise in analytical method development of biologics including monoclonal antibodies, fusion proteins, and other complex modalities. Highly skilled in applying structure-function insights to support drug development, comparability and control strategies.

Senior Leader

Overseeing a team of 30+ direct and indirect reports supporting analytical method development and process support for biologics. Proven track record of building high performing teams, driving scientific strategy, and enabling robust program development across modalities through strong cross-functional collaboration.

CMC Analytical Lead

Experienced CMC analytical lead guiding programs from early clinical development through commercialization and post-market support. Expert in establishing phase-appropriate strategies, control systems, and regulatory submissions to ensure analytical readiness across the product lifecycle.

Method Development

Leader in analytical method development spanning physico-chemical, bioassay, and automation platforms. Known for driving innovation and implementing cutting edge technologies and strategies to enhance assay performance, throughput and scientific rigor across biologics portfolio.

Method Validations

100+

Methods Developed

250+

Automation Platforms

5+

Resume

15 Years of Experience

Education

2017
University of St. Joseph

M.S Biochemistry

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2010
University of Connecticut

B.S in Chemistry

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Experience

2023 -Present
Alexion Pharmaceuticals (AstraZeneca Rare Disease Unit)

Director, Head of Biologics Analytical Development for Physchem, BBI, Automation and Process Analytical Sciences

2021- 2022
Alexion Pharmaceuticals (AstraZeneca Rare Disease Unit)

Associate Director, Head of Biological Analytical Development and Process Analytical Support

2020 - 2021
Alexion Pharmaceuticals

Senior Manager, Analytical Sciences

2018 - 2020
Alexion Pharmaceuticals

Manager, Analytical Sciences

2016 - 2018
Alexion Pharmaceuticals

Supervisor, Process Analytical Sciences

2015-2015
Alexion Pharmaceuticals

Development Associate III

2012-2014
Alexion Pharmaceuticals

Development Associate II

2011-2012
Alexion Pharmaceuticals

Development Associate I

2010-2011
MannKind Corporation

Pharmaceutical Analytics Associate

Design Skills

Web Design

95%

Print Design

65%

Logo Design

80%

Graphic Design

90%

Coding Skills

JavaScript

85%

PHP

70%

Python

60%

Perl

75%

HTML / CSS

100%

Smarty / Twig

80%

Contact

Get in Touch

203-296-0938

Oxford, CT

emily.sciortino@outlook.com

Open To Work