Manager, Microbiology

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. In July of 2018, Argonaut acquired LyoGen, a leader in dose specific lyophilization capabilities for the diagnostics markets. 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 provide leadership to the microbiology team, and to develop and manage all aspects of the microbiology program for cGMP facilities that support Drug Product and Medical Device manufacturing. The position will also be responsible for supervising departmental personnel as well as in-process and final product testing, environmental monitoring and upkeep and maintenance of the instrumentation and lab in a cGMP compliant manner. Previous experience with aseptic filling operations and controls is required.

General Responsibilities

The Manager of Microbiology:

  • Directs the development and implementation of activities in the microbiology group to meet production goals, quality, and cost objectives
  • Develops, revises and reviews SOPs and Qualification/Validation Protocols and Reports
  • Manages and conducts lab investigations
  • Serves as Subject Matter Expert for internal or external customers
  • Participates in inspection readiness activities and is significantly involved in inspections by regulatory agencies
  • Audits and manages third party testing laboratories as required
  • Coaches/mentors staff as a means to ensure performance and professional development

Specific Responsibilities

The successful candidate will:

  • Lead and assist in performing all tasks necessary to achieve the organization’s mission and help execute growth plans
  • Interact and coordinate with compliance efforts across departments to provide a high degree of assurance that all microbiological activities are completed to requirements
  • Oversee execution in routine microbial analysis, environmental monitoring, grow promotion, and assays related to in-process testing, utility monitoring (WFI and gases) and drug product release
  • Accountable for data trending, metrics and reporting for all microbiological monitoring programs
  • Responsible for the QC Microbiology and Aseptic Techniques Training programs
  • Lead non-conformance, EM excursions and out of specification investigations and assist in determining root cause and implementation of CAPAs
  • Evaluate and implement continuous improvement initiatives
  • Review regulatory guidance, compendial requirements and other relevant technical documents to identify and implement changes and current trends in the industry

Position Requirements and Experience

The desired candidate will have:

  • Experience in Environmental Monitoring requirements and tests, Aseptic Process Validation (APV), USP/EP Microbiological methods and microbial identification and experience in managing a Quality Control laboratory under GMP compliance
  • Proven credibility as a leader in the life science/pharmaceutical manufacturing environment
  • Proven track record of exceptional performance in these FDA regulated environments with audit experience from the FDA, other regulatory agencies and clients
  • Experience and expertise in communication exchanges with clients during tours, meetings and audits
  • A proven capability to generate shareholder value
  • Negotiation skills to maximize value in client/regulatory body discussions
  • A “hands-on” management style with the interpersonal skills required to build a successful team and the desire to motivate, inspire and develop management team members
  • High intelligence and problem-solving skills
  • Excellent oral and written communication skills and listening skills

Qualifications

  • A Bachelor’s degree in Microbiology or a related scientific discipline is preferred; and seven (7) or more years of progressive, relevant, experience is required in the pharmaceutical or biotech industry. Three or more years of supervisory experience also required
  • Strong experience in aseptic techniques, and clean room operations
  • Working knowledge of USP, EP, and Annex 1
  • Time and project management skills with the ability to multi-task are essential
  • Must be able to effectively build and lead teams
  • 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 preferred

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 U.S.

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