Senior Drug Product Manufacturing Associate

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.

Position and Scope

The purpose of this position is to perform tasks and operations relevant to the bulk formulation and/or filling operations required for sterile production of liquid injectable pharmaceutical products under cGMP regulations in Drug Product Manufacturing.

General Responsibilities

  • Performs various routine manufacturing tasks under the direction of internal SOP’s and cGMP guidelines
  • Prepares material components for manufacturing operations
  • Operates various lab equipment
  • Documents steps clearly in production batch records, log books and other controlled forms
  • Participates in inspection readiness activities
  • Performs basic arithmetic and algebraic computation
  • Maintain cleanliness of areas and equipment
  • Mentors junior level associates
  • Collects and disposes of lab wastes according to established procedures

Specific Responsibilities

The successful candidate will:

  • Operate automated drug product filling line under isolator technology using proper aseptic technique, gowned in accordance with Class C (ISO 7) conditions
  • Perform sterile filtrations of drug product using proper aseptic technique, gowned in accordance with Class C (ISO 7) conditions
  • Formulate Drug Product Bulk of varying complexity using proper aseptic technique, gowned in accordance with Class C (ISO 7) conditions
  • Execute validation protocols
  • Operate an autoclave to sterilize various components required for production
  • Draft SOP’s and raw material specifications relevant to drug product
  • Adhere to requirements that will ensure the validated state is maintained
  • Provide technical expertise when called upon

Position Requirements and Experience

The desired candidate will have:

  • Experience operating automated filling lines utilizing isolator technology
  • Experience executing complex bulk formulation
  • Experience in communication exchanges with clients during operations
  • High intelligence and problem-solving skills
  • Excellent oral and written communication skills and listening skills

Qualifications

  • High school diploma or equivalent with five (5) or more years progressive, relevant, experience is required or a Bachelors in an Engineering discipline or life science field with three (3) or more years of relative experience
  • Time and project management skills with the ability to multi-task are essential
  • Must be able to effectively communicate within department and cross functionally with other divisions
  • High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction
  • Experience in a growth-oriented, cGMP contract manufacturing organization with a focus on compliant execution of business is a plus

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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