Director, Technical Operations

The Director of Technical Operations will oversee a team of process engineers, equipment engineers, and engineering services team members. The Director will be primarily responsible for the technical transfer and scale-up process, automation, and continuous improvement projects all within full compliance with GMP and other regulations. This position also promotes safety, compliance, best practices, manufacturing standards and resource optimization. This individual is responsible for being a champion for a safe work environment and developing objectives that improve the safety culture within our team and the site.

Responsibilities

  • Lead a team of process engineers, equipment engineers and technical transfer associates to support manufacturing and technical transfer activities
  • Attend Senior Staff meetings to develop and drive initiatives for achieving business unit goals
  • Review client audit findings and implement corrective action, where applicable
  • Work with Commercial and R&D teams to prepare project bid estimates for clients
  • Ensure project milestones are met and monthly deliverables are achieved
  • Participate as requested in multi-disciplinary investigations to determine the root cause for Quality failures or identify changes necessary for manufacturing operations
  • Attend all project kick-off meetings to appropriately set client expectations and ensure standardized approaches to tech transfer programs
  • Lead routine meetings with largest customers to track key performance indicators
  • Review and approve validation protocols and final reports for client specific projects
  • Ensure ongoing process capability improvement and cost savings for development programs
  • Participate in self-development activities and training
  • May establish and maintain systems to track department deliverables and trend performance against metrics
  • Understand and support the unit’s compliance with GMP and all its related elements such as documentation (SOP’s and validation protocols, etc.)
  • Complete annual performance appraisal for direct reports
  • Influence key plant and corporate team members to execute in a timely manner

Qualifications

  • BS, MS or PhD degree in natural sciences, engineering or related discipline
  • 10+ years experience in pharmaceutical/biotechnology industry, experience in a cGMP/FDA regulated environment required
  • Experience with material flows and processing regulatory requirements
  • Knowledge of production equipment and environmental controls appropriate for GMP manufacturing. In-depth knowledge of fill/finish manufacturing unit operations, including troubleshooting of processes and equipment. Ability to compare different types of production equipment and assess impact to existing and new manufacturing processes for Quality, Safety, and efficiency
  • Ability to drive cost improvement on existing and new manufacturing (formulation, fill, and kitting) processes within Regulatory and Quality requirements for the site
  • Current in cGMPs and how to implement management systems that promote cGMP compliance
  • Computer literate with good working knowledge of spreadsheet software (Visio or equivalent drawing program a plus)
  • Ability to work with minimal supervision and interact well with clients as well as interdepartmentally
  • High-level presentation skills with the ability to talk to people at all levels within the organization

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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