- Setup, operating, and tear down of large scale fermentors including monitoring of in-process fermentation parameters
- Ensure batch records are filled out accurately and completely according to cGMP guidelines.
- Weigh out chemicals and nutrients to prepare medium and/or buffer solutions following detailed instructions
- Assist in monitoring of manufacturing inventory and preventative maintenance of process equipment
- Undertake and implement projects with a focus on safety and/or compliance risk reduction, process and equipment robustness improvement, and capacity/productivity/efficiency enhancement.
- Ensure department is clean and organized at all times and free of hazards and safety violations, maintain areas in high state of inspection preparedness
- Maintain records to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and SOPs
- Requirement: Must be able to wear a respirator
- This is a night shift position (working hours 12AM - 10AM)
- AA or BA/BS in a technical field (biotechnology, chemical engineering, bioengineering, microbiology, biochemistry) or equivalent experience, and experience working in a cGMP industrial setting
- Familiarity with bench scale fermentation units (e.g. PALL, Sartorius, DASGIP, Applikon and New Brunswick Eppendorf)
- Knowledge of anaerobic microbiological techniques and SIP & CIP of process equipment, a plus
- Strong attention to detail and strong experience in aseptic techniques, required
- Ability to work off hours and weekends as needed
- A team player with an open, transparent communication style, required
- Proficient in Google suite and/or Microsoft Office
- Must be able to lift 50lbs and stand for long periods at a time
- Medical, Dental, and Vision
- Commuter Benefits
- Life & STD Insurance
- Company match on 401 (k)
- Flexible Time Off (FTO)
- Equity
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manufacturing development associate - San Francisco, CA, United States - Pendulum Therapeutics
Description
Pendulum is on a mission to help people improve physical and mental health by creating a new category of products that target the microbiome.
We are researching, developing and commercializing a novel class of rationally-designed Live SynbioticsTM (probiotics + prebiotics) that have demonstrated clinical efficacy to treat conditions like metabolic syndrome, inflammation and neurodegeneration.
Pendulum has created proprietary pipelines to build a unique discovery platform that identifies key, novel bacterial strains and the prebiotics that feed them.
We are a highly collaborative team of scientists, engineers, physicians, marketers and salespeople interested in improving human health by using the latest research from diverse fields, such as microbiology, molecular biology, high-throughput genomics, distributed computing, pharmaceutical development and nutrition.
We believe strongly in an individual's transparency and strong communication to enable the most effective and efficient path to team success.
If you're interested in building a new category of products that will help improve the lives of people globally and you love working in a cross-functional, collaborative, inspiring environment, please continue reading
We are seeking a Manufacturing Development Associate to join our growing team and support Pendulum's current and future commercialization efforts.
In this role, you will operate large scale fermenters to meet production needs for clinical trial studies, as well as for commercial release.
Working closely with our stellar Manufacturing, Quality, and Compute teams, you will be working hands on in the front lines of production, while helping to continuously improve our cutting edge bioprocess from the ground up.
Our ideal candidate brings previous experience in a cGMP bioprocess or biotechnology setting, and enjoys working with precision in a fast-paced, changing environment, while bringing attention to detail, collaboration, passion, and dedication to their work.
What You'll Do:
* $75,000
opportunity employer. All qualified applicants will receive consideration for employment without regard to
race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics,
disability, age, or veteran status. We welcome all to apply.