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Senior Development Associate/Scientist I

Senior Development Associate/Scientist I

ID 
2017-1076
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 Senior Development Associate/Scientist I is a hands-on laboratory position within the analytical sciences group responsible for analytical method development, optimization, qualification and transfer for biologic molecules from early to commercialization stage. This position will support the in-process, release and characterization testing for residual DNA, host cell proteins, and other process-related residuals. This position will also support investigations, characterization, and comparability studies.

 

Responsibilities and Job Duties

  • Design and conduct experiments to develop in-process, release, and characterization methods for residuals impurities testing of biologics products
  • Implement methods for quantitation of other process residuals including buffer components and excipients
  • Qualify and transfer analytical methods (immunoassays, ELISA, residual DNA, PCR, and HPLC based methods)
  • Act as a subject-matter expert in process residuals analytical methods and strategies
  • Author protocols, operating procedures and technical reports
  • Author analytical sections for regulatory filings
  • Present study conclusions at internal and external scientific meetings
  • Operate and maintain analytical instrumentation
  • Ensure proper documentation through data organization and laboratory notebooks
  • Train other analysts

Qualifications

Education & Experience

Senior Development Associate

  • Bachelor’s in Biochemistry, Chemistry, or life sciences with a minimum of 8 years of related experience

OR

  • Master’s in Biochemistry, Chemistry, or life sciences and a minimum of 5 years of related experience

 

Scientist I

  • Bachelor’s in Biochemistry, Chemistry, or life sciences with a minimum of 12 years of related experience

OR

  • Master’s in Biochemistry, Chemistry, or life sciences and a minimum of 9 years of related experience

OR

  • PhD in Biochemistry, Chemistry, or life sciences and 0 years of related experience

 

Knowledge, Skills and Abilities

  • Strong knowledge of residuals and impurities analysis of biologics including immunoassays, ELISA (enzyme-linked immunosorbent assay), residual DNA analysis, PCR (polymerase chain reaction), and chromatography methods and equipment
  • Ability to develop and qualify residual Protein A or L, residual DNA and host cell protein methods.
  • Knowledge of ICH guidelines and regulatory requirements for qualification and validation of residuals methods
  • Familiarity with MS Word, Excel, PowerPoint
  • Ability to work well with team members and cross-functional colleagues
  • Industrial experience in developing, qualifying and transferring methods

 

Preferred Qualifications

  • Working knowledge in surface plasmon resonance binding or cell-based bioassays
  • Experience in quantitation of different buffer components and excipients
  • Experience drafting analytical sections for IND and BLA filing
  • Working knowledge of Quality by Design (QbD) based development
  • Experience working in a GLP and/or GMP environment
  • 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.