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Development Associate II/III – Analytical Sciences (Method Development & Characterization)

Development Associate II/III – Analytical Sciences (Method Development & Characterization)

ID 
2017-1105
Category 
Development
Job Location 
US-MD-Rockville
Type 
Regular Full-Time

More information about this job

Overview

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

 

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

The Development Associate II/III is a hands-on position within the analytical sciences group responsible for analytical method development, optimization, qualification and transfer for biologic molecules from early to commercialization stage. This role will primarily be focused on chromatography and electrophoresis based separation methods.  This position will also support investigations, characterization, and comparability studies.

                             

Responsibilities and Job Duties

  • Design and conduct experiments to develop analytical release, stability, and characterization methods for biologics products.
  • Qualify and transfer analytical methods (HPLC, UPLC and Capillary Electrophoresis based methods) to evaluate product quality and stability.
  • Complete documentation to support testing procedures including data capture, forms, logbooks, and inventory batch records.
  • Execute comparability studies, analyze experiment data, draw conclusions, and interpret results.
  • Contribute to protocols, operating procedures and technical reports ensuring timely and accurate completion.
  • Contribute to analytical sections of IND, BLA and other regulatory documents working with the analytical method development, quality and regulatory groups.
  • Prepare and present study conclusions at internal and external scientific meetings using clear and concise methodologies.
  • Operate and maintain analytical instrumentation, understanding and adhering to all safety rules and procedures to ensure personal safety and meet required specifications and regulatory requirements.
  • Participate in a variety of projects designed to improve the quality and efficiency of the development team.

Qualifications

Education & Experience

Development Associate II

  • Bachelor’s degree in Biochemistry, Chemistry, or life sciences and a minimum of two years of related experience

Or          

  • Master’s degree in Biochemistry, Chemistry, or life sciences. No experience required

Development Associate III

  • Bachelor’s in Biochemistry, Chemistry, or life sciences and a minimum of five years of related experience

Or          

  • Master’s in Biochemistry, Chemistry, or life sciences and a minimum of two years of related experience

 

Knowledge, Skills and Abilities

  • Strong knowledge of separation techniques for biologics including size exclusion, ion exchange, reversed phase based chromatography methods, and capillary electrophoresis
  • Strong working knowledge HPLC, UPLC and CE equipment
  • Ability to develop and qualify chromatography and electrophoresis based methods
  • Knowledge of ICH guidelines and regulatory requirements for qualification and validation of methods
  • Working knowledge of Quality by Design (QbD) based development
  • Solid skills in MS Word, Excel, PowerPoint
  • Ability to work well with team members and cross-functional colleagues

Preferred Qualifications

  • Industrial experience in developing, qualifying and transferring methods
  • Experience performing CQA analysis of antibody based molecules
  • Experience drafting analytical sections for IND and BLA filing
  • Experience performing multiple analytical comparability studies
  • Experience with late stage development
  • Experience representing CMC teams in a matrix environment

Supervisory Responsibilities

None

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

 

For more information about our commitment to equal employment opportunity, please click here.