Quality Control Senior Associate at OpenBiome
OpenBiome is the world's first stool bank—a nonprofit organization that is expanding safe access to Fecal Microbiota Transplantation (FMT) and driving groundbreaking clinical research on the human microbiome.
Since launching in 2013 out of MIT, our stool banking service has redefined the standard of care for an emerging field of medicine. When we began, only a handful of clinicians offered FMT, a treatment that has an 85% cure rate for C. difficile, the most common hospital-acquired infection in the country. Today we support FMT programs at over 1,000 medical centers across all 50 states. OpenBiome has delivered more than 45,000 treatments for recurrent C. difficile infection, radically improving the lives of thousands of patients that lack treatment alternatives.
OpenBiome has also emerged as a leading independent research organization. We have developed a pill formulation for FMT, published more than 20 scholarly works and enabled the launch of 30 clinical trials in indications spanning autoimmune disease, infectious disease, malnutrition, metabolic disease, and obesity, and neuropsychiatric disease, to identify opportunities for microbiome-based health interventions. The research that we enable is at the vanguard of understanding how the microbes in our bodies shape major public health challenges.
The Senior Quality Control Associate is primarily responsible for managing OpenBiome's stability program. Additionally, he/ she will focus on process improvement to the existing stability system as well as executing on deviations, CC, CAPAs, invalid assays, and OOS results.
Position Responsibilities / Duties:
- Maintain the Reference Standard and Stability Programs
- Perform data analysis and trending of stability data in support of monitoring and method life-cycle programs
- Provide strategic /technical guidance and support for all stability operations and related quality systems (change controls, CAPA, deviations, etc.
- Support routine microbiological testing of raw materials, in-process materials and final products in accordance with SOPs and applicable regulations
- General maintenance of lab equipment
- Participate in writing and revising SOPs and Protocols
- Maintain log books related to inventory and equipment as necessary
- Ensure labs are clean and safe (in compliance with cGMP) and properly stocked
- Participate in Method Transfers, Qualifications, Verifications, and Validation
- Assist in regulatory submissions and responses
Skills, Knowledge, Qualifications, and Experience:
- Bachelor's degree in microbiology (preferred), or related field
- Direct Experience Working on a GMP stability program
- At least 3-6 years of Quality Control experience
- Ability to work independently with minimal supervision
- Self-starter, detail-oriented, data-driven, and a team playe
- Be flexible and excited to work in a fast-paced environment with evolving needs
OpenBiome is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, status as a qualified individual with disability, or any other legally protected status. All applicants must be able to show proof of eligibility to work in the United States.