Sr. Scientist

Overview

We are seeking a Sr. Scientist to support the National Institutes of Health’s (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Gaithersburg, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with groundbreaking research. Candidates will work at a prominent and vibrant NIAID worksite to directly support exciting ongoing research activities as a contractor team member. Accelerate your career and apply below to help us make a difference.

 

CAMRIS International is a dynamic clinical research and international development firm that achieves 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. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs. 

 

Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.  

Responsibilities

• Conduct upstream process development and tech transfer of production processes toward clinical manufacturing of VRC vaccine and antibody clinical candidates within the Cell Culture Development group at the VPP.
• Provide subject matter expertise to lead scientists and/or associates to develop upstream process methods that meet the productivity and product quality characteristics to achieve successful production of clinical material. Including:
  • Designing optimization studies (e.g., DOE with JMP).
  • Use of high-throughput automated AMBR15 and AMBR250 bioreactors.
  • Use of fed-batch bench scale bioreactors and scalable Single-Use-Bioreactors SUBs at 50 L (supporting 250 L, 1000 L, and 2000 L manufacturing vessels).
• Develop pDNA production platform using microbial cell cultures in both shake flask and controller-programmed stirred-tank bioreactor formats.
• Collaborate with Project Managers to ensure upstream development milestones are appropriately set and met on time.
• Serve as a subject matter expert (SME) in guiding cell culture strategies (media/feed evaluation, control parameter tuning, etc.) for new vaccine or therapeutic mAb candidates (both mammalian and microbial cultures).
• Responsible for process evaluation/finalization and oversight of process-locked scale up runs to generate material for toxicology studies. Including, editing/approving/execution of process protocols and production. reports.
• Coordinate closely with Manufacturing teams to ensure timely and scale appropriate Technology Transfer is achieved, by pursuing the following:
  • Write/edit/review tech transfer documents (Process Descriptions/Process Flow Diagrams).
  • Serve as Person in Plant or assign designee for initial VCMP production runs.
  • Serve as SME in VCMP upstream troubleshooting and facility fit evaluations.
  • Serve as the VRC upstream SME in external collaborations.
• Generate necessary regulatory docs to enable IND submissions, FDA response, etc.
• Optimize lab operational space, in collaboration with Process Team Operations Manager and VPP Scientific Operations group, to implement and sustain an optimal productive lab environment (e.g., 5S organizational efforts, KANBAN, or other structural initiatives).
• Encourage and drive innovation to meet new upstream challenges and seeks to publicly distribute novel technologies through presentations at national conferences and/or publication in peer-reviewed journals.
• Performs other duties as assigned.

Qualifications

• PhD in Bioengineering, Chemical Engineering, Biochemistry, or related discipline.
• Minimum of eight (8) years of experience microbiology and/or cell culture research and development.
• Demonstrated knowledge of maintaining accurate and detailed records.
• Must be a team player who can effectively work with members from cross-functional departments.
• Strong oral and written communication skills.
• Familiarity with computer software including word processing and data evaluation.

Physical Requirements:

 

The physical requirements described here are representative of those that must be met by a candidate to perform the essential functions of this job. Reasonable accommodations may be provided to enable individuals with disabilities to perform essential job functions.

• Ability to lift or carry less than 25 pounds, push or pull less tha