Senior Purification Scientist
Camris International

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 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 Senior Purification Scientist to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland.

Responsibilities

• Assist with technology transfer from Process Development to manufacturing environment.
• Plan, order, and account for consumption of raw materials and components.
• Assist in the installation, maintenance, cleaning and operation of bioprocess equipment including chromatography systems, TFF systems, centrifuges, analytical equipment and clean-in-place skids.
• Ensures that standard operating procedures (SOPs) and batch records are accurate, and followed in accordance with cGMP regulatory expectations.
• Conducts purification operations with an excellent understanding and knowledge of isolating and purifying proteins, etc. from microbial and cell culture processes.
• Extensive experience with cell disruption, tangential flow filtration devices, column packing, and chromatography (HIC, IEX, Affinity), aseptic filtration, sampling for QC testing and storage of manufactured products.
• Recognizes and escalates bioprocess operational risks to team lead or Manager prior to failure, to ensure safety and compliance requirements.
• Performs in-process assays to monitor process performance.
• Responsible basic trouble-shooting of technical issues and other problems encountered within the manufacturing process.
• Support initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs.
• Carry out the manufacturing review (as delegated) of the completed batch records and logbooks in a timely manner per established targets.
• Collaborate with the Quality Assurance group to fulfill quality management goals and ensure the highest quality manufacturing processes. Participates in QA training programs as required.
• Identify areas for improvement in manufacturing efficiencies and compliance.
• Assists with process
• Maintains gowning qualification as required.
• Trains, coaches, and mentors manufacturing associates on downstream manufacturing functions, including compliance on all company/regulatory quality systems, safety procedures, and SOPs.
• Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations.
• Occasionally provides support to other areas within the PBF, such as fermentation or Fill/Finish activities.
• May be required to work evenings and weekends.
• Performs other related duties as required and assigned.

Qualifications

• A bachelor's or master's degree in a life sciences (e.g. Biochemistry, Chemistry, Biology), with at least 6 years of experience in the GMP biopharma industry.
• Experience with Downstream cGMP manufacturing of vaccines and therapeutic recombinant proteins is required.
• Experience with operating GE Unicorn software.
• Intermediate computer skills using MS Office (Word, Excel, PowerPoint) preferred.
• Possess excellent interpersonal skills, both communications and written. The candidate in this position must be able to communicate effectively with Management and staff.
• Task & Team-oriented, analytical, organized, detail-oriented, self-motivated & ability to multi-task.

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, 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 Jannsen, is required for this position.

#ZR

This job has expired.