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Senior Biochemistry Operations Manager

Senior Biochemistry Operations Manager

  • Location

    Ashland, MA, United States

  • Sector:

    Quality & Validation

  • Job type:

    Permanent

  • Salary:

    $110,000 - $130,000

  • Contact:

    Callum Sparkes

  • Contact email:

    callum.sparkes@catalystcareers.com

  • Job ref:

    59690

  • Published:

    3 months ago

  • Expiry date:

    2020-11-01

  • Consultant:

    #

Role Overview

This is an exciting opportunity for an ambitious scientist to lead the Biochemistry Operations function for a rapidly expanding Medical Devices manufacturing organization that have been able to contribute immensely to the US response to COVID-19 in manufacturing diagnostic testing kits.

Role Responsibilities

  • Overseeing a team of 6 scientists in ensuring the highest quality of products are manufactured for customers, with a strong focus on optimizing lateral flow assay designs and processes.
  • Preparing assay validation reports and other assay-related documentation as required by FDA and ISO regulations.
  • Leveraging technical expertise and published literature to help customers solve biochemistry scale up challenges.
  • Leading and supporting biochemistry process design for new programs through scale-up to commercial production. 
  • Coordinating technical transfer of new assays and procedures for scaling up with Production department.
  • Supporting customers in their pursuit of state-of-the-art Rapid Lateral Flow immunoassays development, including reagent screening, proof-of-concept, feasibility study, optimization, validation, and final product development.
  • Managing the manufacturing of reagent batches for commercial production.  Managing pilot deposition of reagents to support manufacturing.
  • Writing GMP documents related to product manufacturing and quality assurance, progress reports, publications, SOP’s, MSDS, etc.

Experience Required

  • BS, MS, or PhD in biochemistry, chemistry, or related field and a minimum of five years related work experience.
  • Experience in a lateral flow production environment or lateral flow development environment
  • Able to design and conduct robust and efficient experiments to solve difficult technical problems.
  • The ability to provide guidance to scientists, lab assistants, and skilled production staff.
  • General computer knowledge (MS Office Suite, statistical analysis packages).
  • Laboratory skills: such as protein purification, antibody conjugation, solution preparation, or ELISA experience.
  • Experience with 21 CFR 820, ISO 13485:2016, and Contract Manufacturing Organizations is desirable

This is a FTE salaried opportunity with a base salary range of $110,000 - $130,000 + employee shares & benefits.

You must be a US Citizen or Permanent Resident Holder to apply for this position, unfortunately no sponsorships are available.