IVD Reagent Manufacturing Specialist

Pattern Bioscience

Austin (TX)

On-site

USD 55,000 - 75,000

Full time

8 days ago

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Job summary

Pattern Bioscience is hiring for a lab-based manufacturing role focused on reagent production and testing in an IVD environment. You will document processes, participate in design transfers, and support validation activities.

Candidates bring hands-on lab experience, proficiency with HPLC, pipetting skills, and strong attention to detail. Ideal applicants hold an associate degree in life sciences or related field, with familiarity with quality systems and enterprise manufacturing software.

Qualifications

  • Minimum: Associate degree in Life Sciences, Chemistry, or Medical Technology with hands-on lab experience and IVD manufacturing exposure.
  • Familiarity with documentation, change control, and quality systems is a plus.
  • Experience pipetting and handling analytical instruments in a manufacturing or clinical setting.

Responsibilities

  • Deliver reagent manufacturing and testing requirements to meet demand in an IVD environment.
  • Complete process documentation and related business system transactions accurately and timely.
  • Support new product design transfer, stability studies, and equipment validations.
  • Assist in experimental plans and parameter adjustments with proper documentation.
  • Contribute to projects targeting efficiency, scaling, and quality improvements.
  • Update work instructions and SOPs and participate in change control.
  • Support investigations and CAPA in audits, non-conformances, and customer escalations.
  • Collaborate in a team to coordinate activities and communicate effectively.
  • Maintain and calibrate measuring and monitoring devices.

Skills

MS Word
MS Excel
HPLC experience
Pipetting
Attention to detail
Problem solving
Critical thinking
Independent work

Education

Associate degree in Life Sciences / Chemistry / Medical Technology

Tools

Enterprise Manufacturing systems

Job description

Pattern Bioscience is hiring for a lab-based manufacturing role focused on reagent production and testing in an IVD environment. You will document processes, participate in design transfers, and support validation activities.

Candidates bring hands-on lab experience, proficiency with HPLC, pipetting skills, and strong attention to detail. Ideal applicants hold an associate degree in life sciences or related field, with familiarity with quality systems and enterprise manufacturing software.

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