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 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
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.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We're focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
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. For more information about equal employment opportunity, visit our Genentech Careers Homepage.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
