Product Development Associate
About Aldatu
Does helping to address the next outbreak drive your interest in biosecurity and pandemic preparedness? Do you want the assays you build at the bench to reach the patients and laboratories that need them most?
Aldatu Bioscience is a Watertown, MA public benefit corporation developing and manufacturing real-time PCR diagnostics using PANDAA (Pan-Degenerate Amplification and Adaptation), our proprietary adaptive-PCR technology. PANDAA is engineered to deliver durable, accurate detection of genetically diverse viral targets where conventional PCR assays fail, turning the viral diversity that defeats other tests into a problem we solve by design.
Backed by more than $20M in non-dilutive NIH funding we manufacture our diagnostic in-house under our ISO 13485-certified quality system. Our assays have been used across the US and a growing network of laboratories in West and Southern Africa. As a small, mission-driven team, every person here has visible, consequential impact on products that reach clinical laboratories around the world.
Leaders in Adaptive PCR
Viral genetic diversity is one of the hardest problems in molecular diagnostics: the same mutations that let viruses evade the immune system also cause conventional PCR assays to return false negatives. PANDAA was built to solve that problem. When SARS-CoV-2 emerged, Aldatu designed and validated one of the first COVID-19 tests in New England — in just 18 days — enabling major Boston hospitals to begin testing early in the pandemic, and our PANDAA SARS-CoV-2 assay went on to deliver uniquely durable detection as new variants swept the globe.
Today we apply that same variant-proof, pan-lineage approach across a portfolio aimed at some of the world’s highest-priority pathogens: drug-resistant HIV, Lassa virus, Crimean-Congo hemorrhagic fever, and Ebola and Marburg. By consolidating what used to take multiple sequential tests into single, robust assays for the resource-limited settings that need them most, PANDAA brings durable, affordable diagnostics to the front lines of outbreak response.
Backed by more than $20M in non-dilutive NIH funding we manufacture our diagnostic in-house under our ISO 13485-certified quality system. Our assays have been used across the US and a growing network of laboratories in West and Southern Africa. As a small, mission-driven team, every person here has visible, consequential impact on products that reach clinical laboratories around the world.
The Person and Role
We are seeking a highly-motivated, detail-oriented Product Development Associate to join our team in a role that spans assay development and regulated product manufacturing. You will split your time between laboratory research supporting our PANDAA-based diagnostic pipeline and the manufacture, testing and release of our commercial products under our ISO 13485 quality system. This is a rare chance to follow a diagnostic product from the bench all the way clinical laboratories across the world, and to have a hand in every stage along the way. It is ideal for someone with strong hands-on molecular biology skills who also takes pride in rigorous documentation and repeatable execution. You will work shoulder to shoulder with our scientific, quality, and operations staff, and because we are a small team, your contributions will be visible and consequential from day one. There are substantial opportunities for growth for a capable candidate.
To be successful in this role, you are expected to have a minimum of two years’ hands-on experience in an academic, biotech, diagnostics or manufacturing setting with practical experience with qPCR/RT-qPCR setup and analysis, and nucleic acid handling. You must have working knowledge of Good Documentation Practices (GDP) and a demonstrated commitment to accurate, complete recordkeeping. You should be willing to commit a minimum of two years as there are substantial growth opportunities within the company for the capable candidate.
What We Offer You
Paid Time Off
- Unlimited PTO, in addition to 6 federal holidays, 2 days over Thanksgiving, and a company holiday shutdown from 24th to 31st December [with flexibility if you need to observe a religious or cultural holiday at another time of year]
Benefits
- Subsidized health, dental and vision insurance with several health insurance options such as HMOs and PPOs and includes cover for your spouse or domestic partner, children, and unmarried dependent children.
- Participation in a 401(k) plan with company contributions.
- Healthy Living Allowance of up to $500 per calendar year in reimbursement for costs incurred related to long-term activities that promote physical wellness.
- Salary range of $72,000 to $90,000
Primary Job Duties
Research & Assay Development
- Plan and execute qPCR and RT-qPCR experiments supporting the optimization, verification and validation of PANDAA-based diagnostic assays.
- Perform core molecular biology techniques, including primer/probe testing, nucleic acid extraction and purification, RNA synthesis by in vitro transcription, and gel electrophoresis.
- Analyze, organize and present data for internal meetings and external audiences (e.g., grant progress reports, partner communications).
- Contribute to technology transfer of new assays from R&D into manufacturing.
Manufacturing & Quality
- Formulate, dispense, label and package diagnostic kit components following approved batch records and SOPs.
- Perform in-process and final quality control (QC) testing, and support lot release and stability studies.
- Complete batch records, logbooks and other GMP/GDP documentation accurately and contemporaneously.
- Maintain, operate and verify laboratory and production equipment; support calibration and preventive maintenance activities.
- Manage reagent and raw-material inventory, including receiving, labeling, storage and cold-chain monitoring.
- Support nonconformance, deviation and CAPA investigations, and help draft and revise SOPs, work instructions and forms.
Required Experience
- BS. or M.S. in molecular biology, biochemistry, microbiology, biotechnology or a related life science field.
- 2+ years of hands-on laboratory experience in an academic, biotech, diagnostics or manufacturing setting.
- Practical experience with qPCR/RT-qPCR setup and analysis, and nucleic acid handling.
- Working knowledge of Good Documentation Practices (GDP) and a demonstrated commitment to accurate, complete recordkeeping.
- Ability to follow detailed procedures precisely while recognizing and escalating anything unexpected.
- Ability to balance R&D and production priorities, meet deadlines and adapt in a fast-paced small-company environment.
- Strong communication, organizational and time-management skills; proficiency with Microsoft Office (Word, Excel, Teams).
- Interest in infectious disease and / or global health.
- Exceptional communication, writing, organizational and time management skills.
Preferred Experience
- Experience working under ISO 13485, 21 CFR 820 (QMSR), GMP or another regulated quality system.
- Experience with diagnostic kit manufacturing, reagent formulation, QC release testing or stability programs.
- Familiarity with QuantStudio real-time PCR instruments.
- Experience with electronic QMS or ELN systems (e.g., QT9, Labguru)
- Demonstrated interest in infectious disease and/or global health.
Application Form
To apply, please fill out the online application form below and complete the questions below. Candidates should also upload a cover letter and CV (including publication list, if applicable) in the form prior to submission.
Aldatu is unable to sponsor employment-based visas at this time. Relocation assistance may be available for qualified candidates. No employment agencies, please.
Contact Name:
Larry Carrasco, VP of Operations
Salary Range:
$72,000 to $90,000