Technical Manager

4 weeks ago


South San Francisco, California, United States Roche Holdings Inc. Full time

Job Summary

The Technical Manager position is a crucial role within our department, encompassing a GMP Media Preparation and Lab Services (MPLS) facility and an MPLS facility supporting Genentech Pharma Technical Development (PTD).

Key Responsibilities

  • Ensure cGMP compliance in South San Francisco Site Operations MPLS facilities.
  • Lead quality events, conduct compliance training, and participate in internal audits.
  • Lead process improvements and maintain compliant operations.
  • Project planning, tracking, documentation, and execution.
  • Assess processes for compliance to cGMP and quality standards.
  • Conduct and document compliance assessments.
  • Evaluate and ensure quality and compliance of SOPs and practices.
  • Lead or own quality Events, action items, and assessments.
  • Support equipment revalidation, new equipment, and troubleshooting of equipment and processes.
  • Handle internal compliance audits and serve on inspection readiness teams.
  • Support lab MES and request systems, including master data, training, and troubleshooting.
  • Lead error tracking, root cause analysis, and corrective actions.
  • Make quality decisions with limited supervision and offer solutions.
  • Lead process improvements with positive impacts on MPLS and other areas.
  • Support functional and cross-functional projects.
  • Ensure safety and compliance in operations.

Requirements

  • Bachelor's degree in Life Science, Engineering, or related field.
  • Minimum six years of relevant pharmaceutical experience.
  • Experience with government and regulatory agencies.
  • Commitment to quality and compliance.
  • Strong background in media prep and glassware operations.
  • Self-starter focused on quality and results.

About Genentech

Genentech, a member of the Roche Group, has been at the forefront of the biotechnology industry for over 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases.

We believe that our employees are our most important asset and are dedicated to remaining a great place to work.

Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society.

We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status.



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