Production Lead

The purpose of this position is to have extensive knowledge in molecular biology/chemistry to support our manufacturing operations and formulations, to coordinate production planning and to execute production schedule, as well as ensure the continuous improvement of the manufacturing process and procedure. We are looking for a true problem solver who can hit the ground running in a new production lab, supporting the establishment of lab procedures along with equipment protocols. Strong time management and organization skills along with interpersonal skills and ability to participate effectively in multidisciplinary teams to solve problems in a manufacturing environment are essential.

Position Requirements and Experience

The desired candidate will have:

  • Strong communication skills and the ability to work with cross functional teams comprised of manufacturing, tech transfer, senior management, QA, and finance
  • Excellent problem-solving skills and the ability to analyze and interpret data to make critical decisions
  • Aptitude to write and execute validation documents
  • Ability to work within an ISO13485 and GMP production environment and maintain compliance with our quality system
  • Must be able to work on several projects or initiatives concurrently, with appropriate time management skills and ability to prioritize
  • Liaises with sales division, production planning, and procurement to determine customer requirements
  • Detailed work ethic, accountable and disciplined in actions
  • Willingness to take ownership and drive projects to completion
  • Develops a production schedule detailing all tasks and when they should be completed by to meet predicted completion date
  • Ability and willingness to perform standing and sitting work in the production lab for extended periods of time
  • Ability to train team members, providing technical guidance and leadership as necessary
  • Prepares reports about production processes for upper management and suggests ways to improve efficiency
  • Skilled at creating and revising manufacturing documentation batch records, SOPs and tech transfer documents, etc.
  • Experience in molecular biology (2 years preferred) with proven skills within a high-throughput manufacturing lab
  • Strong laboratory skills and equipment techniques
  • Production process development background/experience
  • Excellent written and verbal communication
  • Ability to communicate effectively with people in other disciplines
  • Knowledge of Supply Chain and Production Management
  • Organized, responsible and dependable
  • Mathematics Skills, Especially in the Area of Statistics
  • Experiences with product transfers and scale up tech transfers
  • Understanding of Lean Manufacturing Principles and 5S standards
  • Working knowledge of ISO 13485 and cGMP regulatory compliance

Qualifications

  • AAS/AS/BS in Biotechnology, Molecular Biology, or Biochemistry and 2+ years of experience in Manufacturing lab management with focus on molecular biology
  • MS in Molecular Biology or Biochemistry and 1+ years of relevant experience
  • High school diploma or GED and 5+ years of experience in Molecular Biology, Biotechnology, Biochemistry commercial laboratory including leadership, project management experience, and lean foundation training

Corporate Overview

Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final kitting of reagents and consumables. Argonaut provides the quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.

Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies with all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.

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