Senior Manufacturing Associate
About Aldatu
Has SARS CoV-2 or monkeypox piqued your interest in biosecurity and pandemic preparedness? Do you have an interest in infectious disease and / or global health?
Through our innovative diagnostic platform, based on our proprietary qPCR-enabling technology, PANDAA, we are committed to providing access to infectious disease diagnostic that address longstanding challenges in global health, and which improve both the quality of patient care and healthcare cost-efficiency across the world.
Leaders in Adaptive PCR
Viral genetic diversity has been a major hurdle in the development of numerous diagnostic assays. One very prominent example is false negatives COVID-19 test results by SARS-CoV-2 variants.
Aldatu designed and implemented one of the first COVID-19 tests in New England, allowing major Boston hospitals to rapidly implement testing very early in the pandemic. Aldatu’s PANDAA qDx™ SARS-CoV-2 test—which is sold to clinical labs in a number of countries—leveraged the core features of our PANDAA technology to enable uniquely durable detection of SARS-CoV-2. Like our other diagnostics, this offers distinct longevity and utility for testing despite changes that may arise as viruses continues to evolve.
Our expanding R&D and product portfolios includes products for drug-resistant HIV, COVID-19 detection and variant genotyping, and viral hemorrhagic fevers.
The Person and Role
We are seeking highly-motivated and talented Senior Manufacturing Associate to join our Product Development team. Successful applicants will possess strong molecular biology skills and a demonstrated interest in global health and / or infectious disease. Our new team member will work closely with our Product Development team to design and execute the development and validation of PANDAA-based diagnostic products. They will support expansion and refinement of quality management systems, securing ISO 13485 and CE-IVD certification and take ownership of day to day manufacturing and order fulfillment activities.
To be successful in this role, you are expected to have a minimum of three year’s hands-on experience in an academic or biotech setting, with experience in Quality Management Systems, be independently motivated, goal oriented, technically competent, and work effectively in a team environment. 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
- Up to 30 days vacation each year: 18 days flexible paid time off in your first year, which is 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 $82,400 to $89,900
- Participation in a twice-yearly performance-related bonus scheme.
Primary Job Duties
- In conjunction with the Product Development team, support and execute on activities of the following Manufacturing and Quality system requirements:
- Refinement and expansion of Aldatu’s Quality Management System, with the goal of obtaining ISO 13485 and CE-IVD certification.
- Contributing team member to develop and ensure all procedures, training, technical files and product records are compliant with SOPs and QMS regulatory standards throughout all stages of product development.
- Data collection and user and training documentation for design and analysis software.
- Day-to-day Quality Management System upkeep and ongoing documentation.
- Manufacturing, kitting, order fulfillment and shipping process for product sales and research activities.
- Support validation of future research-use assays and clinical diagnostics.
Required Experience
- BS. or M.S. with 3+ years of laboratory research experience in molecular biology, assay development, microbiology, or similar life science field.
- Demonstrated experience with diagnostics manufacturing and ISO-certified Quality Management Systems.
- Interest in infectious disease and / or global health.
- Demonstrated experience in one or more of the following molecular biology techniques: reverse transcription (RT)-PCR, nucleic acid manipulation, and sequencing techniques.
- Experience with real-time PCR setup, analysis using basic analytical QC methods, documentation of results, and reagent inventory management. Experience with QuantStudio real-time PCR platform is a plus.
- Ability to balance/prioritize research efforts across multiple programs, meet deadlines, and shift plans in service of a rapidly-changing startup environment
- Exceptional communication, writing, organizational and time management skills.
- Exemplary lab notebook practices, and attention to detail in recordkeeping
- Experience Using Microsoft Office products, including Word, Excel, and Teams
Preferred Experience
- Experience with molecular biology software tools, and electronic notebook (e.g. Geneious, ApE, Serial Cloner, Artemis)
- Previous experience in biotech or pharma.
Application Form
To apply, please fill out the online application form. 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:
$82,400 to $89,900