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Scientist I/II, Analytical Sciences

Scientist I/II, Analytical Sciences

ID 
2018-1119
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 Scientist I/II is a hands-on position within the analytical sciences group responsible for analytical method development, characterization, and comparability studies for biologic products. This position will lead efforts in development of chromatography, capillary electrophoresis, and biophysical methods for release, stability, and characterization of protein-based products. This individual will work closely with other development and quality functions in a results-driven, collaborative environment to support early to late stage development of molecules leading to commercialization.  He/she will be responsible for the choice of experimental methodology, carrying out the analyses and providing interpretations and conclusions from the results in a report for each project in a timely fashion.  He/she is also expected to train analysts on analytical methods and techniques.

 

Responsibilities and Job Duties

  • Develop and qualify chromatography, capillary electrophoresis, and biophysical methods for release, stability, and characterization of protein-based products according to compendial and regulatory guidances.
  • Design and conduct forced degradation characterization studies of product-related variants in support of Critical Quality Attribute (CQA) assessments.
  • Purify fractions containing the product-related variants, identify and characterize the variants to support CQA assessments.
  • Lead or support analytical comparability studies to support drug substance and drug product process changes.
  • Lead or support platform and technology development activities to advance analytical platforms used for in-process, release and stability testing of biologic molecules.
  • Author analytical sections of IND, BLA and other regulatory documents working with the analytical method development, quality and regulatory groups. Author protocols, operating procedures, and technical reports.
  • Present study conclusions at internal and external scientific meetings.
  • Operate and maintain analytical instrumentation and train analysts.
  • Serve as an analytical resource for the department and project teams, proactively keeping colleagues updated with current scientific trends and technical aspects from conferences, local meetings, and the literature.

Qualifications

Education & Experience

Scientist I

  • Bachelor’s in Biochemistry, Chemistry, or life sciences and 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

Scientist II

  • Bachelor’s in Biochemistry, Chemistry, or life sciences and a minimum of 14 years of related experience

       OR

  • Master’s in Biochemistry, Chemistry, or life sciences and a minimum of 11 years of related experience

      OR

  • PhD in Biochemistry, Chemistry, or life sciences and a minimum of 2 years of related experience

Knowledge, Skills and Abilities

  • Experience in separation techniques for biologics including size exclusion, ion exchange, reversed phase based chromatography methods, and capillary electrophoresis
  • Ability to develop and qualify chromatography and electrophoresis based methods
  • Knowledge of ICH guidelines and regulatory requirements
  • Experience with analytical comparability study design and execution
  • Experience in critical quality attribute (CQA) assessment and Quality by Design (QbD) based development
  • Experience in product characterization and forced degradation studies
  • Experience drafting analytical sections for regulatory filings, such as INDs and BLAs
  • Strong understanding of CMC functions
  • Strong communication, presentation, and writing skills

Preferred Qualifications

  • Industrial experience in developing, qualifying and transferring methods
  • Experience with late stage development
  • Experience representing CMC teams in a matrix environment
  • Experience in orthogonal characterization techniques for protein mass, size, structure and charge
  • Experience with particle analysis or biophysical techniques Experience in functional assays including binding (Biacore), ELISA, or cell-based bioassays

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.