Manufacturing Specialist - San Carlos, CA | Biospace
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Manufacturing Specialist

NuGEN Technologies, Inc.

San Carlos, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

NuGEN Technologies is looking for a highly motivated, technically savvy Manufacturing Specialist  to join our Operations team.  The successful candidate will play a hands-on role in the manufacturing of our innovative genomics solutions including custom-built products and will also provide support on planning related activities, act as a liaison to other functional groups, and lead special projects.  He/she will enjoy working both individually and as part of a team in a fast-paced environment.

The successful candidate will have strong laboratory skills in molecular biology or biochemistry and excellent attention to detail.   In addition, the ability to communicate and collaborate successfully with others is critical to success.  Position reports to Director of Production and is located in San Carlos, California.  No relocation available.  Please send updated resume.


•   Actively participates in manufacturing wide variety of innovative genomics products
     o   Adheres to good documentation practices and ISO 13485 guidelines
     o   Involved in range of processes including formulation and kit assembly
     o   Issues batch records, transacts work orders and manages material transfers in ERP system
     o   Schedules daily builds and internal requests based on like products and commercial priorities
     o   Ensures manufacturing suites are stocked with necessary build materials and liaisons with Purchasing for re-ordering.
     o   Assesses scalability opportunities and concerns; initiates appropriate actions (as needed)
     o   Identifies and sources manufacturing equipment to improve productivity
•   Assists with routine communication within production and regarding schedule and availability.  May be involved with updating ERP system with ship dates and/or customer service.
•   Assists with review of completed batch records for completeness and checks for deviations on builds produced by others.
•   Ensures proper lab practices are followed, including work in biosafety hoods, gowning, and routine decontamination processes of manufacturing suites.
•   Participates in various operations activities ( e.g. physical count/cycle count, ISO or customer audits )
•   Ensures manufacturing batch records and SOP documentation procedures accurately reflect current processes.  Available to initiate change orders if revisions are required.
•   May be involved in investigations related to non-conformances or any other production related process improvement opportunities.
•   May assist in product development projects as creator/co-creator of new manufacturing batch records and packaging configurations via change order process; working with product development scientists and other related departments to transfer new products to Manufacturing.
•   May assist in material assessment with Purchasing  


•   Bachelors Degree in life sciences or equivalent experience required.  
•   3+ years hands-on laboratory experience in molecular biology or biochemistry required.
•   Demonstrated skills in manufacturing planning required.
• Experience using ERP database system for manufacturing related activities required.
• Hands-on technical experience in Next Generation Sequencing (NGS) a plus.