Associate Director, Instrumentation and Calibration Services

South San Francisco
California, United States of America


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The Position

The Associate Director, Instrumentation and Calibration Services will report to the Director of FOM and be responsible for setting and implementing the vision and strategy and leading the Lab Support Group (LSG) that consists of four organizations: Instrumentation and Calibration, Metrology, AOW (Autoclaves, Ovens & Washers) and CoolOps (portable refrigeration equipment) for GMP and R&D areas.  LSG performs business critical services for Genentech’s manufacturing and research organizations.  These services span over 5m sq. ft. and 25,000 assets across 5 campuses on 2 sites.  This leadership position provides  oversight of the LSG organization and manages 6 Managers/Supervisors and a workforce of approximately 40 people. This new position requires an experienced leader to optimize service levels that meet or exceed industry standards, achieve efficiencies and set lab service strategies and priorities.  The successful candidate will strengthen department capabilities comprised of business processes, technologies, data analytics, metric dashboards and training to drive business and compliance improvements and ensure sustainable drug delivery.  The LSG leader is directly accountable for all LSG GMP regulatory records  and will ensure through their team, that remediation plans and corrective and preventive actions (CAPA’s) are developed and completed.

The Associate Director will oversee their staff as they provide technical support and problem solving capabilities including equipment troubleshooting and utilize equipment trends to ensure reliable system performance.  The AD  will interact with key customers and stakeholders and keep them apprised of priorities, status, continuous improvement initiatives and solicit their feedback.   He or she  will partner with key customers and calibration vendors to align on and implement service and efficiency improvements. The LSG AD  must emphasize exemplary customer service and communication skills to staff and contractors and centrally oversee communication activities to deliver clear and consistent messaging linked to goals and expected leadership behaviors.

Responsibilities

  • Provide direction and coaching to managers and supervisors on business and organizational priorities, issues and challenges. Identify and implement strategies to develop future capabilities and create value within the LSG team of 45 employees.
  • Guide the LSG team to develop solutions for complex problems that require a high degree of ingenuity, creativity and innovativeness.
  • Accountable for the on-time execution of ~20,000 work orders per year
  • Oversee and provide strategic direction for Instrumentation and Calibration support of GMP production, IMP small molecule production and research areas including the assessment of optimal insource/outsource strategies (calibration vendors) to evolve staff capabilities, meet business needs and drive efficiencies.
  • Identify opportunities for continuous improvement and pursues changes and upgrades to processes and procedures as warranted. Including optimizing the maintenance strategies and calibration intervals
  • Negotiate constructive win/win solutions to resolve complex issues using a collaborative style/approach. Model “One Team” behaviors across Site Services
  • Drive quality and on-time performance.  Ensure all aspects of day-to-day LSG operations are reliable, efficient and meet right-to-operate compliance. Present to auditors and investigators from regulatory drug agencies, internal teams and CAL- OSHA.
  • Oversee the LSG team to address findings with auditors and investigators from regulatory inspections. Ensure the team delivers on the resolution of GMP discrepancies, develops CAPA’s and own compliance records
  • Oversee equipment SOP reviews (both existing and new) and ensure that  they are accurate and updated, including GMP SOP’s.
  • Engage with senior level customers and stakeholders to set lab service strategies and ensure alignment of priorities and mitigate compliance risk and achieve efficiencies. Resolve customer escalation issues.
  • Meet with directors from other pharma companies to discuss best in class practices and optimum organizational structures
  • Influence and motivate staff and others to achieve goals and objectives.

Requirements

  • College Degree in Engineering or other technical field required. MBA is desired.
  • 10 – 15 years managerial experience in a bio-pharma environment is required
  • Demonstrated track record of increased responsibility in facilities management at a large biopharmaceutical or comparable site. Minimum of 10 years of proven leadership experience with facilities management, maintenance program management and laboratory equipment maintenance, spanning multiple sites or campuses totaling at least 1 million square feet.
  • Strong technical knowledge in metrology, instrumentation and calibration for lab equipment is required. Knowledge of autoclaves, lab ovens, glassware washers and refrigeration equipment highly desired
  • Knowledge of campus infrastructure, building and laboratory equipment, and control, monitoring and alarm systems is essential.
  • Deep experience with GMP compliance and demonstrated ability to oversee department discrepancy investigating and reporting, and development and implementation of compliance CAPAs, records, SOPs and training documents.
  • Develop and manage department budgets, partnering with finance to develop business cases to support investments and demonstration of year over year financial savings.
  • Develop and implement strategies to create new value, efficiencies and improve reliability spanning staff, vendors and service providers.
  • Demonstrated experience driving program and capability improvements spanning business processes, technologies, data analytics, dashboard reporting and training.
  • Experience using structured problems solving, LEAN, Six Sigma, Statistical Process Control and Data Analytics to drive business results.
  • Knowledge of Master Data, SAP and CMMS and experience analyzing data to identify risks and opportunities.
  • Experience assessing service delivery options and leading change improvements to create value for customers and stakeholders.
  • Track record leading large teams and service providers and developing people to drive positive transformation.
  • Experience establishing trust and nurturing a culture of diversity and inclusion, cooperation and partnership across staff, customers, stakeholders and service providers and encouraging staff to “Speak Up” to share ideas and concerns.
  • Ability to communicate concisely with key customers, stakeholders and leadership at Director level and above.

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Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.


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