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Process Development Biochemist

Carma Search

Process Development Biochemist

San Diego, CA
Full Time
Paid
  • Responsibilities

    Process Development Biochemist

    Overview:

    The Process Development Biochemist is responsible for developing and optimizing the formulation process. Accountable for aligning critical product components including lyophilization, chemical formulation, conjugation, strip assembly to achieve successful launch of robust diagnostic products. This position is responsible for performance optimization of manufacturing components and processes via team working with members from multiple disciplines. Participates in day-to-day operations with responsibilities in manufacturing process improvements, cost optimization, quality testing, inventory management and labor accountability.

    Duties:

    • Regularly communicate with R&D, Engineering and manufacturing teams to understand the development of tests kits for in-house R&D, clinical trial, and customer use
    • Develop and optimize formulations, and manufacturing processes
    • Develop the operating protocols and documents that meets ISO 13485 and cGMP standards
    • Support the implementation of automation processes to improve manufacturing throughput
    • Adhere to the OSHA safety code and company policies
    • Work directly with QA personnel to support ISO 13485 and cGMP certification
    • Assist with developing capacity plan to support production requirements.
    • Support internal and external audits when necessary
    • Training junior manufacturing personnel to implement efficient manufacturing workflow
    • Equipment Management (Specifications, IQ/OQ/PQ, Calibration and Preventive Maintenance)

       

      Skills:  

    • Direct knowledge of manufacturing processes
    • Direct knowledge of lyophilization, conjugation, formulation of IVD diagnostic products
    • Direct knowledge of PCR and DNA oligomer quantification
    • Direct knowledge of PCR enzyme

       

      Requirements:  

    • Ability to read, write and speak English.
    • Strong written and oral communication skills.
    • Strong organization skill
    • Strong problem-solving skill
    • Demonstrates team working competencies and ability to lead the project to meet production schedules.
    • Education:  

    • Bachelor’s degree plus a minimum of 3 years of experience in an in-vitro diagnostic industrial setting.