CAMRIS International is a medical research and development 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, global health security, biodefense, and clinical research.
We are seeking a Biologics Process Development Senior Engineer to support the Pilot Bio-Production Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland
* Demonstrates cGMP manufacturing compliance and quality mindset without continuous supervision.
* Leads and contributes to technology transfer of biologics processes, performs risk assessments and represents PBF at meetings.
* Leverages broad experience to operate and train staff; and if needed performs non-routine maintenance on laboratory equipment.
* Leverages advanced academic background and industry experience to design, lead and implement process characterization and biologics scale-up.
* Creates, revises and executes cGMP documentation including procedures, specifications, and automation recipes.
* Assists cGMP operations.
* Assists in development, optimization and implementation of bench and production scale upstream, downstream and fill-finish process development.
* Leverages experience, bioprocessing expertise and leadership to advance WRAIR PBFs projects.
* Reviews and authors development and engineering run batch records as required.
* Compiles and reviews executed development data, engineering run data, process data and Master Batch Records.
* Recommends and specifies equipment and other supply purchases within the development areas.
* Prepares equipment and materials specifications.
* Compiles data supporting risked-based process decisions, presents data and resolves mitigation through research and experimentation.
* Leads and supports initiation and closure of investigations, deviations and CAPAs.
* Reviews cGMP records and data as required, supports regulatory CMC sections as required and represents PBF at technical conferences.
* Responds and/or monitors equipment as required to equipment notifications.
* Performs other duties as assigned.
* Bachelors degree in engineering or sciences degree with additional industry experience. Masters in Engineering or PhD in related science preferred.
* 8+ years Good Manufacturing Procedures (cGMP) manufacturing
* Familiarity with related fields such as microbial physiology, general microbiology, microbial fermentation, mammalian cell culture, physical chemistry, and biochemistry preferred.
* Independently lead manufacturing teams as required potentially working off-hour shifts as required and resolving process alarms
* Experienced in operation of bioreactors, centrifuges, ultrafiltration, and cell disruption equipment
* Proficient at Microsoft office, especially MS Excel and Word
* Support initiation and closure of deviations and CAPAs, lead investigations and be responsible for closing deviations
* Compilation of upstream electronic and offline data
* Comfortable and effective presentation of process data to internal and external peers, customers and stakeholders
* High throughput process parameter screening, DOE and data analysis preferred.
* Programming experience and familiarity with pharmaceutical industrial automation systems is a plus preferred.
CAMRIS International offers competitive salaries and comprehensive benefits. Please submit your resume online at https://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, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.