Technical Operations Manager

  • IncellDx
  • Atherton, CA 94027, USA
  • Apr 21, 2017
Full time Biotech Science

Job Description

•Manage inventory planning to ensure uninterrupted supply of finished goods.

•Manage CMOs and OEM manufacturers for routine production. Coordinate investigation and trouble-shooting for CMO manufacturing processes.

•Primary responsibility for Quality Control of IncellDx products, including testing, review and approval of test records, and maintenance of QC materials inventory.

•Represent manufacturing department during design control activities and design reviews for new products.

•Document and revise manufacturing and quality control procedures, establish sampling plan rationale; collaborate with Product Development to document material specifications and oversee accurate transfer of product Design to Manufacturing.

•Conduct technical studies to support manufacturing, quality control and product development; investigate non-conformances, solve product-related technical problems and troubleshoot as needed; document and approve results in Non-Conformance Reports, Corrective Action Reports and/or Technical Reports.

•Ensure proper receiving, labeling and location of materials in accordance with company SOPs; track product inventory levels, provide monthly inventory report to COO and investigate inventory discrepancies with accounting.

•Supervise and perform internal manufacturing procedures e.g product labeling and assembly.

•Trend quality control and product performance results as input to Management Review
Meetings.
•Participate in Risk Analysis of manufacturing processes using FMEA.

•Supervise Stability Study Program to establish product shelf life and transport methods.

•Work cross-functionally as needed to support all company and department objectives

•Act as back-up for shipping and invoicing activities; perform check entry into QuickBooks

•Manage one direct report.Work conditions and physical requirements

•The work is performed indoors, in a general office environment and in a biology laboratory.

•Some tasks require the ability to work for extended periods of time on a computer.

•Some tasks require the ability to work for extended periods of time at the lab bench, performing complex, repetitive manual tasks and detailed visual observations.

•Some tasks require the use of hazardous and/or toxic chemicals and potentially hazardous biological materials.

•Some tasks require the ability to lift up to 40lbs.

•Some tasks require the ability to climb on mobile platform ladder.

•On-call duties for temperature monitoring of equipment.

•Must be able to read, write, and communicate fluently in English.


Qualifications

•MS plus 2-5 years related work experience in Medical Device Manufacturing

•Experience working in FDA QSR/ISO 13485, 9001 regulated environment

•Highly detail-oriented yet flexible

•Comfortable in a quick paced environment; able to shift priorities when needed

•Excellent written and verbal communications skills

•Flow cytometry experience is a plus

•Cell culture experience is a plus