About us: Lucira Health is a startup striving to transform the way infectious diseases are diagnosed. Lucira Health is the first at-home COVID test authorized by the FDA. Our technology is a single-use, user-friendly COVID test kit that can produce a positive or negative result at home within 30 minutes. This technology bypasses centralized medical lab testing and streamlines patient care. Our current areas of focus include COVID and influenza.
As Process Development Scientist atLucira Health, Inc., you will be working cross-functionally with other groups across the company to design and execute experiments to support the characterization and validation of manufacturing processes and test methods. This person will be expected to lead the effort transferring function testing methods to contract manufacturing sites. One of the key development projects that this position with be involved in is the coordination and transition of testing process for lyophilized beads from Lucira to a CM. This scientist will also be in charge of supporting our in-house reagent manufacturing. This position will also be expected to generate work instructions, test plans, test reports, and other project documentation to meet quality and regulatory requirements for a medical device.
Primary Job Function:
- Lead the project to transfer lyophilized bead testing to the contract manufacturing facility.
- Mange project timelines and tasks to enable a smooth transition.
- Write work instructions, DHRs, test plans and validation protocols.
- Support the aseptic reagent manufacturing process including continued process improvement and quality monitoring.
- Drafting experimental test protocols, executing tests, and writing reports
- Drafting validation test plan and test reports
- Setting up and pipetting molecular assay reactions (RT-PCR or NGS) using both wet and lyophilized reagents.
- Experience with LAMP amplification is a plus.
- Operate lab instruments such as thermocyclers and plate readers
- Perform reaction setup of molecular assays in a BSL-2 environment under GLP (Good Laboratory Practice) and general safety regulations
- Compile test data, statistically analyze results, and develop reports and presentations to summarize findings
- Involved in performing process gap analyses and PFMEAs
- Design experiments to evaluate molecular assays test methods and establish robust protocols for use during in-process testing and function lot release of the Lucira product
- Work with engineers to test fixtures and equipment.
- Deliver medical device design documentation compliant with FDA design controls and good documentation practices including creating and maintaining medical device Design History Files and Device Master Records
- Formulate molecular buffers and reaction mixes in both R&D and Production environments following Good Manufacturing Practice (GMP), include the completion of DHRs and batch records.
- Assist with the procurement of supplies and general laboratory maintenance.
Additional Job Functions Include:
- Troubleshoot and deduce conclusions and recommendations from experimental results using a systematic approach
- Ability to work independently and autonomously without direct oversight
- Work well in a group and can effectively manage assigned project tasks
- Writing a variety of protocol and test report documents
- Maintaining concise experimental records
- Requires a Bachelors Degree in Biology, Biochemistry or Chemistry with 3-5+ years of experience.
- Medical device development experience desirable.
- Experience with aseptic manufacturing or lab practices is desirable
- Experience working with molecular diagnostics
- Experience operating liquid handling systems (such as TECAN, Hamilton, Agilent) is a plus
- Experience with molecular assays such as LAMP or RT-PCR
- Experience with PCR and qPCR system platforms
- Experience working with lyophilize reagents desirable
- Documenting and executing process OQ/PQ and V&V studies desirable
- Experience in Product development and product transfer is preferred
- Familiarity reagent formulation and lyophilization desirable
- Proficient Microsoft Project, PowerPoint, Word and Excel.
- Experience using statistical analysis tools such as MiniTab or JMP a plus
- Experience working in and creating documentation for a GMP environment
- Must have demonstrated cross-functional team effectiveness, excellent interpersonal and written communication skills.
Lucira Health is an Equal Opportunity Employer
Individuals seeking employment at Lucira Health are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation.