GMP Operations Specialist

CAMRIS • Silver Spring, MD

72d • Onsite

About The Position

We seek a GMP Operations Specialist to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. The Operations Specialist will support manufacturing in the following areas Upstream, Downtime, Purification, and Fill Finish. PBF is a one-of-a-kind cGMP-compliant pharmaceutical manufacturing facility engaging in next-generation development for cutting-edge companies and government agencies. The professionals at PBF are engaging in trailblazing endeavors every day. Most exciting, the end products vary, so every year brings multiple opportunities for professional enrichment in original projects.
CAMRIS International, LLC, is a dynamic medical research and 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 vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; 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.
Note: This is a forecasted position.

Requirements

• A bachelor’s degree in a science field (preferably chemistry, biochemistry, microbiology, or engineering) and four+ years of industry experience performing cGMP production, downstream, purification, fill finish and upstream in a clean room environment.
• Experience with aseptic gowning, aseptic processing, aseptic final filtration and working in a cleanroom environment.
• Must be able to work independently following a brief period of specific technical training.
• Must have familiarity with related fields, such as general microbiology, physical chemistry, and biochemistry.
• Must have some knowledge of the operation of automated/manual filling machines, Restricted Access Barrier System (RABS), and labeling machines.
• Experience in filling parenteral products under GMP conditions.
• 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.

Nice To Haves

• Professional knowledge and experience requirements related to viral product safety for product release and downstream purification (chromatography) a plus.
• Experience with bioproduction equipment: centrifuges, tangential flow filters, spectrophotometer, biosafety cabinets, sonicator, autoclave, roller bottles a plus.
• cGMP experience for large-scale viral production of biological products a plus.
• Working knowledge of disposable manufacturing methodologies, such as the use of sterile bags with tubing and tubing welders is a definite plus.
• LIMS experience and experience with equipment monitoring systems are a plus.

Responsibilities

• Upstream: Prepare cell culture for virus inoculation and prepare viral seeds.
• Provide input on cell culture, bioproduction and purification of mammalian cell-based products.
• Experience and knowledge of cGMP, specifically bioproduction of viral vaccines.
• Execute and participate in cGMP viral growth, virus vaccine purification for cGMP vaccine bioproduction.
• Aseptic gowning, aseptic processing, aseptic final filtration and working in a cleanroom environment.
• Cell culture experience (adherent cells a plus), washing and counting cells, repeated trypsin manipulations.
• Maintain virus vaccine bioproduction inventory, order equipment and reagents.
• Downstream: The downstream part of a bioprocess refers to the part where the cell mass from the upstream are processed to meet purity and quality requirements.
• Execute cell expansion of seeds and viral seeds as required.
• Manage and maintain manufacturing-owned controlled temperature units (CTUs) and incubators per site policies and procedures.
• Perform bioreactor setup, operation, maintenance, and cleaning per site policies and procedures.
• Prepare harvest equipment per SOP and batch record instructions per site policies and procedures.
• Execute cell lysis through chemical or physical (e.g., microfluidizer) cell disruption.
• Perform recovery mid-stream unit operations, including but not limited to depth filtration, centrifugation, and tangential flow filtration as required and per site policies and procedures.
• Pour resin, pack columns, verify HETP and Asymmetry, and equilibrate columns.
• Develop purification batch records and AKTA UNICORN methods as required.
• Analyze UNICORN and other downstream result files, attach per GDP to records, summarize data, and incorporate analysis into run reports as required.
• Sanitize, empty, and store columns per site policies and procedures.
• Purification: Separation of contaminants closely imitating the product in physical and chemical properties.
• Prepare buffers pour columns with specific resins, lyses cells to homogeneous suspensions.
• Perform extractions of cells and cell products.
• Use column chromatography, centrifugation, and other techniques to purify vaccine materials.
• Make recommendations for the purification of desired products based on research data received from research personnel.
• Responsible for all types of purification and downstream processing and the use of various equipment to meet these goals.
• Perform various analytical procedures to characterize and quantitate the product at all steps in the purification process.
• Fill Finish: Filling, Formulation and Lyophilization of desired products.
• Perform scheduling of filling/lyophilization of desired products.
• Perform bulk thaw, dilution, and formulation operations.
• Set up equipment/machines aseptically for proper operation, including installing and disassembling equipment and parts required for filling and formulation operations.
• Perform all documentation and clerical functions to provide the proper accountability and traceability of components and finished product.
• Operate cleanroom equipment aseptically and efficiently (lyophilizer, manual and automated filler equipment, vial washer, part washer, autoclave, labeler, and dehydrogenation oven).
• Perform full-scale lyophilization of vaccine lots, including monitoring cycle parameters while in process.
• Perform labeling of final product vials.
• Operation and non-contract maintenance of the filling machines, freeze-dryer, and sterilization equipment; preparation of all glassware, reagents, and materials that are used for a filling operation.
• General Duties:
• Adheres to current Good Manufacturing Procedures (cGMP) guidelines and FDA regulations as they apply to all levels of work.
• Assist in writing Standard Operating Procedures and production batch production records.
• Adept at problem-solving. Specifically in identifying problems, developing solutions, executing remedies, and elevating problems to management if necessary.
• Follow basic safety/EHS requirements, SOPs, cGMP, work rules, and other company policies.
• Maintains a safe workplace, ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training related 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.
• Must have proficiency with various types of office software: Outlook, Word, Excel. MS Project; LIMS experience and experience with equipment monitoring systems are a plus.
• Must have the ability to follow directions, written policies, and procedures for work responsibilities.
• Licensed vaccinations might be required to work with certain viral agents.
• Must have good people and communication skills (written and verbal).
• Performs other duties as required.

Benefits

• CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees