Technical Operations Manager - Menlo Park, CA | Biospace
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Technical Operations Manager

IncellDx

Location:
Menlo Park, CA
Posted Date:
4/19/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

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.

Requirements

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