South San Francisco, CA, United States
Bluecollar, Manager, Manufacturing, Sciences, Engineering, Pharmaceutical
The Manager of Clinical Packaging
will own the accountability for the safe, cost-effective, and efficient operation of secondary clinical packaging processes for Genentech’s biologics, device, and small molecule products. The Manager will ensure full compliance with current Good Manufacturing Practices and Genentech quality policies and standards and will be responsible for managing a team of approximately 7-9 non-exempt level employees.
In addition to managing the responsibilities below, the successful candidate will need to demonstrate the following traits:
Able to collaborate with both local plant, other sites, and corporate organizations seamlessly
Passion and drive to develop and maintain a LEAN culture dedicated to providing the best results for our internal and external customers
Constantly in search of creative and innovative solutions to maintaining the highest levels of productivity
Leadership necessary to maintain a high-performance culture
Maturity and experience to be an ad-hoc member of the PTDS South San Francisco Leadership Team
Performance will be measured by South San Francisco Genentech site and Roche global metrics.
Accomplish results through subordinate non-exempt staff. Lead, motivate, and encourage staff to achieve departmental and company goals. Provide effective coaching and guidance.
Ensure work environment meets Genentech and industry standards and ensure team consistently delivers production requirements to prevent any disruption to global clinical supply.
Participate in the development of safety goals and manage operations so that all safety goals are met. Trend safety performance and reinforce safety practices throughout the department. Provide oversight to ensure adequate resources and priorities for safety improvement initiatives. Monitor and ensure safety training compliance. Model safe work behaviors.
Ensure facility is always regulatory inspection-ready such that all audits, both internal and external, are met with ease and without undue preparation. Represent area and process(es) for internal/external Audits and act as the SPOC for compliance issues within the department. Review trend data to ensure quality compliance and correct negative trends as required. Reinforce quality practices throughout the department. Develop and maintain cGMP training requirements for staff. Ensure strict adherence to cGMP’s, CFR, ANNEX and Roche/Genentech Pharma Quality System and Global Produce Quality Product policies/procedures. Maintain a strong alliance with the Quality organization.
Perform assessment of operations using LEAN principles and make necessary adjustments to maximize production output and labor efficiency while meeting required safety and quality levels. Participate in the development of production, productivity, and financial goals and manage operations so that all department goals are met. Ensure conformance with production schedule.
Review and approve manufacturing documentation including tickets and SOPs. Create and maintain controlled department documentation as required. Review and support closure of manufacturing variances and incident reports.
Manage the performance planning process for all direct reports. Coordinate department level hiring and staffing. Actively participate in the Talent Review process. Spend at least 50% of the time managing.
Ensure completion of all required training activities (i.e., safety, cGMPs, technical skills, processing operations, etc.) to maximize organizational effectiveness. Foster continuous learning and create developmental opportunities to ensure continued growth of staff
Ensure departmental financial objectives are met by monitoring expense, capital budgets, reconciling variances and developing and implementing cost improvement programs as necessary. Participate in business reviews and forecast future manpower, space, and capital requirements
Develop and maintain department KPIs
Communicate proactively with management, stakeholders and sponsors regarding progress, issues and plans for issue resolution
Operate with a high degree of autonomy and professionalism
Maintain an environment of continuous improvement and business process thinking
Effectively sponsor, lead and/or participate on internal continuous improvement projects
Ensure effective integration of system implementations and department business processes
Partner with Global Packaging Engineering, Device Development, and Small Molecule Pharmaceutics to develop new capabilities for the Clinical Packaging team
Partner with various IT teams, for example SAP CLARA, PT IT, etc., to enhance existing systems and develop new digital capabilities
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
Education and Experience
Bachelors degree in Life Sciences, Engineering, Business Administration or equivalent
Minimum of 10 years of Manufacturing experience, preferably with packaging and inspection experience
Minimum of 5 years supervisory experience, having managed non-exempts
Experience working in a cGMP manufacturing environment
Familiar with FDA and European guidelines
Knowledge, Skills, and Abilities
Must have knowledge of cGMP standards, a proven track record of leading cGMP compliant operations through successful internal (PTQ) or external (ex: FDA, EMA) inspections
Requires strong interpersonal, communication, customer service, organizational and prioritization skills
Successful demonstration of leadership, teamwork, problem solving, decision making and technical skills
Working knowledge of Operational Excellence tools (ie. 5S, Visual Factor, TPM, DMAIC, etc.) required
Manage assignments that are complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations
Working knowledge of Quality systems (i.e. change control, validation, discrepancy management, etc)
Proficiency with computer programs MS Word/Excel/PowerPoint, Visio, Project
Knowledge of ERP system
Familiar with pre-clinical, clinical, and reference materials/finished goods
Ability to work in a fast paced, dynamic work environment
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
Website : http://www.gene.com