CAMRIS International, LLC is a medical research, development, and cGMP manufacturing firm that realizes innovative solutions to health and development challenges through high-quality, cost-effective program 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, cGMP manufacturing, global health security, biodefense, and clinical research.
We are seeking a Senior Viral Manufacturing Mid/Downstream Specialist to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland.
- Transfer new viral processes to mid and large-scale runs, establish process gap analysis, and develop process improvements
- Implement GDP and cGMP standards compliant with product-specific regulatory requirements.
- Responsible for writing Standard Operating Procedures, Batch Production Records, and any other documents that are required to maintain documentation and compliance with current Good Manufacturing Practices.
- Review and execute manufacturing instructions, engineering records, and cGMP production batch records as required.
- Recover and purify viruses, viral vectors, and VLPs using:
- Column chromatography
- Depth filtration
- AKTA or automated protein purification chromatography
- Tangential flow filtration or UF/DF
- Prepare and set up equipment, pack and load columns, conduct HETP/asymmetry, and prepare buffers.
- Maintain and operate recovery and purification process equipment in the Viral Manufacturing Group.
- Lead multidisciplinary project teams as required.
- Support QC and VDAD groups as necessary leveraging various analytical procedures to characterize virus quality and quantify virus at all steps in the viral recovery and purification process.
- Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. The employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
- Performs light duties and other related duties as required and assigned, including working in other sections.
- A master's degree in biotechnology, chemical engineering, or a related discipline, with a minimum of 8 years of experience, or an equivalent combination of education and experience.
- Previous experience working in a GLP/GMP environment is preferred.
- Knowledge of aseptic techniques and behavior.
- Experience with single-use technologies and closed processing is desirable.
- Previous experience in viral clearance, including viral inactivation and nanofiltration.
- Experience working in a matrixed team environment.
- Pilot and/or development scale manufacturing experience.
- Strong communication (written and verbal), organizational, and time management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and customers.
- 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.
Full 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.
Employment is contingent upon successful completion of a background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.