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Manufacturing Associate I
3 months ago
Invivoscribe is an industry pioneer, dedicated to Improving Lives with Precision Diagnostics®. Invivoscribe has been the global leader in driving international standardization of testing and accelerating patient access to the newest and best cancer treatments for over 25 years.
Headquartered in sunny San Diego, California with locations across the world, we offer a comprehensive portfolio of products and services. We work with key collaborators to develop molecular assays, reagents, controls and bioinformatics tools under ISO 13485 design control that are used by over 700 clinical laboratories in over 160 countries.
Our global network of laboratories offers internationally standardized next generation molecular and flow cytometry panels to support drug development and accelerate drug approvals worldwide. We work with pharmaceutical partners and international regulatory agencies across the globe to develop companion diagnostics, which are necessary to gain approval of new drugs and treatments for cancer patients. Our harmonized ISO15189 accredited and CLIA/CAP clinical laboratories offer a test menu focused on biomarkers which are clinically actionable to support therapeutic decisions, measurable residual disease (MRD) testing, patient stratification, and trial enrollment, all designed to accelerate approvals of new oncology drugs and treatments.
For 25 years, we have been at forefront of precision diagnostics, and we’re just getting started
We are looking to add a Manufacturing Associate I supports the daily activities of the Manufacturing Team in the production of reagents, master mixes, controls and/or assay cartridge/kits.
Core Responsibilities Include:
- Performs production activities per schedule.
- Participates in the production of master mixes and ASR, reconstruction of oligonucleotides, controls, reference standards and general-purpose reagents by following manufacturing batch records, work instructions, standard operating procedures, forms and validated Excel spreadsheets.
- Verifies all materials necessary are available for production; prepare tubes/boxes/labels and formulation/fill.
- Maintains appropriate inventory levels of raw materials and supply items used in production.
- Ensures the production environment is maintained consistent with SOPs, operating practices and regulatory requirements.
- Maintains general lab cleanliness, equipment, monitors temperature/pressure in specified areas or equipment and monitor levels of LN2 and CO2 on specified equipment.
You Bring:
- B.S. Degree in a scientific discipline and, typically, 1+ year(s) applicable experience in a GMP regulated industry; equivalent combination of education and experience may be considered.
- Familiarity with a manufacturing environment, including the use of SOPs, batch records, ERP systems and purchasing specifications is advantageous.
- Basic knowledge of PCR and molecular biology is advantageous.
- Familiarity with Microsoft Office Suite (Word, Outlook, Excel) and the ability to learn new software programs.
We Bring:
- A beautiful modern facility centrally located in San Diego County.
- A diverse and inclusive work environment where you will learn, grow, and make new friends.
- A well-stocked breakroom with hot and cold beverages, snacks, refrigerator and pantry items to get you through the day.
- Competitive salaries and bonus program, amazing benefit options, a 401k plan with a fully vested employer match, and generous time off benefits that include floating.
Invivoscribe is an Equal Opportunity Employer.
