Lyophilization Manufacturing Lead
At Biomeme we make things. We make hardware; we work with biological organisms; we hack smartphones. We're looking for passionate people who are skilled with their hands and have impeccable attention to detail. You should be a fast learner and not afraid of tackling challenges both big and small. No task is above or below your pay grade.
Biomeme is as interdisciplinary as it gets. We combine rigorous biology and chemistry with best-in-class hardware and software engineering. It's all wrapped up in sublime user design, with the goal of helping our customers enact real-world change. Guided by data and a belief in the iterative process, we develop elegant solutions to complex problems that demand precision.
Our partners and customers span a wide range of industries across the US, Latin America, Africa and Europe. We've got great traction in health: we're testing for STD's in Philadelphia, Malaria and Ebola virus in Africa, Avian Influenza in Europe, veterinary targets in the Andes and Lyme disease in the US. Outside of health, we have partners in industrial water monitoring, aquaculture, agriculture, conservation biology and more. High school students are testing for mislabeled sushi. Quantified Selfers are tracking their microbiome. Everyday users are even testing their own DNA for genetic markers.
We are also currently working to manufacture and distribute COVID-19 test kits in the United States and Canada. It’s a good time to come onboard.
Philadelphia, PA 19107
Graduate Degree in relevant scientific disciplines
We are seeking a Lyophilization Manufacturing Lead to become an immediate and valuable contributor to the Manufacturing team. The Manufacturing Lead is integral to the production of our novel shelf stable nucleic acid assays and will be accountable for maintaing the lyophilization facility and in-house manufacture from reagent acquisition through QC of products, under a quality system compliant for regulated markets.
- Manage Biomeme's newly installed lyophilization facility including:
- Material acquisition and inventory
- Receiving inspection
- Reagent preparation
- Lyophilization process and troubleshooting
- Quality control of product
- Implementation and enforcement of our quality management system
- Hiring and supervision of staff for sub-roles
- Oversight of facility and equipment maintenance and calibration
- Project management
- Implementation of new products and processes
- Delivery of lyophilizaed product on-time within budget
- Creation of SOP's and other documents in support of our quality management system (ISO 13485)
- Ensuring compliance to the companies quality management system and standards
- Minimum of 5 years of professional experience
- Strong experience in reagent manufacturing for pharmaceutical, diagnostics, or life sciences
- Knowledge and experience of GMP and manufacturing regulatory requirements
- Knowledge of basic biochemistry and molecular biology concepts
- Working knowledge of standard laboratory biochemicals and molecular biological reagents
- Knowledge of ISO 13485 or 21 CFR quality standards
- Management experience of personnel
- Experience in lyophilization concepts and techniques
- Knowledge of regulatory requirements for diagnostic assays
- 10 years' professional experience
- Excellent attention to detail
- Strong organizational abilities
- Great communicator
- Friendly, articulate and interested in working in a fun, fast-paced small company
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Video Cover Letter
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