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Technical Manager, MPLS - Site Services

Genentech
United States, California, South San Francisco
Nov 17, 2024
The Position

Join our dynamic team at Genentech as a Technical Manager in a role that spans across our innovative GMP and Development Media Preparation and Lab Services (MPLS) facilities. You will play a crucial part in supporting Pharma Technical Development, ensuring compliance, driving quality initiatives, and leading process improvements. If you are passionate about using your technical expertise to cultivate excellence in pharmaceutical operations, this is the opportunity for you.

The Technical Manager position is within a department that includes a GMP Media Preparation and Lab Services (MPLS) facility and an MPLS facility supporting Genentech Pharma Technical Development (PTD). Responsibilities cover both areas.

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.
  • Provide guidance on compliance topics and motivate MPLS personnel.
  • 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.
  • Promote positive organizational change.
  • Identify and escalate compliance and business issues.
  • Apply LEAN methodologies and train team members in continuous improvement.
  • Support lab MES and request systems, including master data, training, and troubleshooting.
  • Lead error tracking, root cause analysis, and corrective actions.
  • Collaborate and be a technical resource for teams.
  • Make quality decisions with limited supervision and offer solutions.
  • Lead process improvements with positive impacts on MPLS and other areas.
  • Present findings to various stakeholders.
  • Support functional and cross-functional projects.
  • Ensure safety and compliance in operations.
  • Communicate professionally with customers and team members.

Requirements:

  • B.S. in Life Science, Engineering, or related field.
  • Minimum six years of relevant pharmaceutical experience.
  • Experience with government and regulatory agencies.
  • Strong analytical and communication skills.
  • Ability to influence personnel across boundaries.
  • Commitment to quality and compliance.
  • Strong background in media prep and glassware operations
  • Passion for teamwork and continuous improvement.
  • Leadership and problem-solving skills.
  • Self-starter focused on quality and results.

The expected salary range for this position based on the primary location of California is $82,900 - $153,900 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits 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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