Snapshot of Responsibilities:
- Routine preparation and qualification of biochemical reagents for process development and manufacturing, adhering to required work instructions and SOPs
- Fabrication of lyophilized assays, preparation of master mixes, testing/analysis of raw chemical materials
- Working cross-functionally, identify failure modes throughout the process, characterize them, and develop mitigation strategies.
- Collaborate with cross-functional teams to develop and implement process improvements, ensuring optimized and efficient manufacturing operations.
- Conduct cross-functional process investigations and root cause analyses to identify and address deviations, non-conformances, and other process-related issues. implementing corrective and preventive actions as necessary.
- Development of work instructions and standard operating procedures in partnership with members of the R&D team and broader Operations organization.
- Documentation and Communication: Organize data, analyze results, and communicate findings to cross-functional teams. Author technical documents such as protocols and test reports.
- Physical demands require ability to lift 15kg
- Physical demands required may require standing on your feet for extended periods of time, although much of the lab work can be executed while sitting
- Perform other duties as assigned.
What You Bring:
- Bachelor’s Degree in biological sciences with 0-1 years of experience. Preferred: 1-2 years of relevant work experience in life sciences manufacturing role.
- Awareness of GLP, ISO13485, and GMP quality standards.
- Experience following work instructions or SOPs.
- Previous experience of using a variety of laboratory equipment including pipettes, centrifuges, laminar flow hoods, etc.
- Background knowledge of DNA amplification, lyophilization, and the use of freeze dryers is a plus.
- Strong communication and collaboration skills, with the ability to work effectively in a cross-functional team environment.
- Detail-oriented, with a commitment to ensuring compliance and delivering high-quality results.
- Strong interpersonal skills will aid effective communication and teamwork within the manufacturing team.
- More broadly, we are looking for a proactive team player with the initiative, flexibility, drive and enthusiasm to achieve goals and exceed expectations in a dynamic startup
- Experience working in a 6S environment preferred.
- Medical device or other regulated industry experience preferred.
- Start-up environment experience preferred.
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What We Do
OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. Together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, OraSure provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers.








