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CAMRIS · 5 hours ago

Operations Specialist

Silver Spring, MD

Full-time

Onsite

Mid Level

4+ years exp

CAMRIS International, LLC is a dynamic medical research and development firm focused on innovative health solutions. The Operations Specialist will support the Pilot Bioproduction Facility at the Walter Reed Army Institute of Research, engaging in cGMP-compliant pharmaceutical manufacturing processes, including upstream and downstream bioproduction activities.

BiotechnologyInformation Technology

Comp. & Benefits

No H1B

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

Qualification

CGMP experienceBioproduction equipmentViral product safetyCell cultureChromatographyAseptic processingBachelor's degree in scienceLIMS experienceMicrosoft Office proficiencyCommunication skills

Required

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

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

Hepatitis B immunity is required; vaccination will be provided if needed

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

Preferred

Professional knowledge and experience requirements related to viral product safety for product release and downstream purification (chromatography) are 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 is a plus

Working knowledge of disposable manufacturing methodologies, such as the use of sterile bags with tubing and tubing welders, is a definite plus