Biologics Process Development (BPD) Purification Specialist
Camris International

Silver Spring, Maryland

Posted in Science and Research


Job Info


Overview

CAMRIS International, LLC is a medical research and development firm that realizes innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research.

We seek a Biologics Process Development (BPD) Purification Specialist to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland.

Responsibilities

  • As assigned, act as technology transfer lead on programs.
  • Coordinate and communicate technology transfer with development, operations, and external technical staff.
  • Design and execute clarification and purification process development studies.
  • Author, review and execute technology transfer protocols and gap assessments.
  • Leverage quality by design (QbD) principles and technical risk assessments.
  • Interpret and summarize publications, donor process information, and experimental data.
  • Develop scale-up processes and cost-benefit analyses for purification process operations.
  • Train and mentor development and operations staff in downstream functions.
  • Support and coordinate with other BPD technical staff (mRNA, CLD, viral etc.).
  • Troubleshoot processes issues and support QA technical investigations as required.
  • Performed other tasks as required.


Qualifications

  • A bachelor's degree in a science field (preferably chemistry, biochemistry, microbiology, or engineering) and 4 years of experience in a regulated environment.
  • Knowledge and experience in chromatography purification, process optimization, scale-up, scale-down, and technology transfer.
  • High throughput process development (HTPD) experience (preferred).
  • Experience performing lifetime and aging of chromatography resin studies (preferred).
  • Familiarity with purification systems, including AKTA Avant and TFF systems
  • Working knowledge of R and DOE.
  • Excellent troubleshooting skills.
  • Strong communication (written and verbal), organizational, and time management skills.
  • Ability to work well independently and as part of a team.
  • Must have eligibility to work in the United States and have lived in the United States for three of the past five years if a non-US citizen.

CAMRIS International LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at www.CAMRIS.com . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

F ull vaccination against COVID-19, defined as two doses of Moderna, two doses of Pfizer, or one dose of Johnson & Johnson's Janssen, is required for this position.



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