Manufacturing Associate I

4 weeks ago

San Diego, United States INVIVOSCRIBE INC Full time
Job DescriptionJob Description

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 to our team for all aspects of production, including the production of master mixes, controls and assay kits. You will contribute to the drafting and review of new documents, including SOPs, Batch Records and Purchasing Specifications.

Core Responsibilities Include:

  • Ensures orders are entered correctly and specimens collected are appropriate for the test ordered.
  • Oversee, perform, plan and schedule production.
  • Work with suppliers of core raw materials to ensure quality, quantity, price and availability.
  • Create, review and revise production documents. Implement and train on the use of those documents.
  • Create and execute validations for production processes and equipment.
  • Participate in the production of master mixes and ASR, reconstitution of oligonucleotides, controls, reference standards and general-purpose reagents by following manufacturing batch records, work instructions, standard operating procedures, forms and validated Excel spreadsheets.
  • Verify all materials necessary are available for production; prepare tubes/boxes/labels and formulation/fill.
  • Maintain appropriate inventory levels of raw materials and supply items used in production.
  • Ensure the production environment is maintained consistent with SOPs, operating practices and regulatory requirements.
  • Maintain general lab cleanliness, equipment, monitors temperature/pressure in specified areas or equipment and monitor levels of LN2 and CO2 on specified equipment.
  • You may providing training and guidance to others as required

You Bring:

  • B.S. Degree in a scientific discipline.
  • 1+ years experience in a GMP regulated industry or equivalent combination of education and experience.
  • Proficient in Microsoft Office Suite (Word, Outlook, Excel and PowerPoint).
  • Direct working knowledge of a manufacturing environment, including use of SOPs, batch records, ERP systems and purchasing specifications is beneficial.
  • Ability to accurately recognize deviation from accepted practice is required.
  • Strong working knowledge of PCR and molecular biology.

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.

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