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 Filling and Formulation Manager to support the Pilot Bio-Production Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland.
- Responsible for managing/directing the Fill/Finish department. Directs the planning and scheduling of filling/lyophilization of desired products.
- Interacts with clients/customers/Principal Investigators (PIs) on a regular basis.
- Makes recommendations for filling/lyophilization methods for various vaccine material based on experience, knowledge, and research data received from PIs. If necessary, will advise on further research to be conducted by appropriate personnel to refine/improve formulation/filling/lyophilization processes.
- Develops lyophilization cycles/processes using knowledge, experience, and data from laboratory and/or full size lyophilizer runs.
- Adheres to current Good Manufacturing Procedures (cGMP) guidelines and FDA regulations as they apply to all levels of work.
- Executes preparation for and performance of both manual and automated filling processes with various types of equipment.
- Executes full scale lyophilization of vaccine lots, including monitoring of cycle parameters while in process.
- Procures labels for filling per QA procedures and oversees labeling of final drug product.
- Assists in maintenance and validation of all preparation, filling, lyophilization and labeling equipment.
- Writes Standard Operating Procedures and Batch Production Records; designs data capture forms and any other documents that are required to maintain documentation and compliance with cGMP.
- Interacts and coordinates with other facility staff in order to optimize production scheduling and sample testing.
- Provides on the job training for department staff. Ensures that training requirements for Fill/Finishing staff are kept up to date. Mentors staff to promote continuing compliance with approved procedures and cGMP requirements.
- Interacts with clients, auditors, and regulators in topic areas related to aseptic filling, lyophilization, inspection and labeling.
- Provides assistance to personnel contractor for formulation/fill-related inquiries, projects and technical reports Maintains a safe and clean workplace, ensuring that self and employees are aware of and observe appropriate safety and occupational health rules and regulations. Required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
- Performs other related duties as required and assigned.
- Supervises direct reports as assigned.
- Monitors direct reports’ job performance.
- Bachelors or better in Biology or related field with 5 years’ experience in aseptic filling and lyophilization.
- Able to coordinate activities among staff to properly execute a filling operations compliant to cGMPs and PBF procedures.
- Working knowledge of disposable manufacturing methodology such as the use of sterile bags with tubing and tubing welders is a definite plus.
- Knowledge of cGMP as applied to biological products, especially to the filling, lyophilization, inspection and labeling of product.
- Supervisory experience
- Experience with aseptic gowning and aseptic processing, including aseptic final filtration; must have experience working in a cleanroom environment.
- Professional knowledge of the principles and practices applicable to lyophilization of vaccines and similar materials.
- Knowledge and/or operation of automated filling machines, Restricted Access Barrier System (RABS), and labeling machines.
- Must be able to work independently following a brief period of specific technical training.
CAMRIS International 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.