Senior Technical Manager, Site Services

The Position

The Senior 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, and robust operations in both GMP and Development MPLS teams.

● Participate in, coordinate, facilitate, and / or manage the implementation of programs,

systems, procedures, functions and processes needed to maintain a ready state of

cGMP compliance.

● Collaborate and partner effectively with Quality and Customer Organizations.

● Lead quality events, conduct compliance training, and participate in internal and external 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.

● Own/support equipment validation efforts, new equipment introduction, and troubleshooting of equipment and processes.  Partner with Validation resources and/or direct external resources to ensure a robust state of compliance.

● Demonstrate Technical Expertise and strength including mastery in media preparation and glasswash processes and equipment including weigh/dispense, sterile filtration, single-use technologies, pH, conductivity, osmolality measurement, local high-purity water systems, autoclaves, washers and ovens.

● Handle internal and health authority compliance audits and serve on inspection readiness teams.

● Provide guidance and high-level consultation on compliance and cGMP topics to all

necessary departments for the purpose of motivating MPLS personnel to ensure

compliance with best work practices.

● Promote positive organizational change.

● Identify and escalate compliance and business issues.

● Apply LEAN methodologies and train team members in continuous improvement.

● Support laboratory execution systemslab (LES) and media prep request system (MPRS)s, including master data, recipe creation,  training, adding new capabilities and troubleshooting.

● Experience with data analytics and data historian systems

● Lead error tracking, root cause analysis, and corrective actions.

● Collaborate closely with customer groups 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 twelve 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 $111,100.00 - $206,300.00 USD Annual.  Actual pay will be determi