Senior Manager, Bioprocess Engineering
Senior Manager, Bioprocess Engineering (Vacaville)
Vacaville, California
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Vacaville Operations is a large scale mammalian cell culture production facility designed around the monoclonal antibody (MAb) platform. It is one of six Drug Substance production sites in the Roche/Genentech Biologics production network. The site consists of two large-scale manufacturing facilities (CCP1 and CCP2), a hub warehouse, and QC laboratories that serve both local and network production operations. The Position:
Accountable for managing a multi-discipline technical group responsible for performing a variety of routine and complex activities under cGMP regulations and standards. The team's primary responsible is providing technical solutions for equipment, facility and utilities improvements in support of the site operations to ensure reliable delivery of drug substances to the global supply chain. Develop and refine solution options and costs to complex issues to enable business decision making. Establish work priorities and timelines in alignment with project and department needs to execute engineered solutions.
Responsibilities and Job Duties:
The successful candidate will manage and administer all aspects of personnel performance and staff development. This includes selection, hiring, and training of personnel on company and department policies, systems, and processes. Coach and develop staff by providing an environment that encourages ongoing personal and professional development. Manage and ensure the setting of realistic goals for staff and provide regularly scheduled feedback throughout the year, including workload balancing. Recommend and implement improvements to policies, plans, and procedures. Manage routine department activities and initiatives, ensuring completion of activities and initiatives on time and within budget. Serve as department representative on cross-functional teams and at senior level meetings. Oversee and direct timely resolution of complex issues through effective interdepartmental and cross-functional partnerships. Clearly and effectively communicate and present complex ideas and concepts to all levels within the company. Establish and communicate strategy, vision and direction for their team.
Technical
Responsibilities:
The successful candidate will be responsible for managing a diverse team comprising a variety of engineering disciplines and skills levels. The candidate will oversee technical solution development and implementation efforts following standard engineering approach, act as a mentor, and provide career guidance. Provide technical leadership while fostering teamwork in a GMP environment across functional and organizational boundaries. Communicate proactively with stakeholders and senior management regarding progress, issues, and plans for resolution.
The candidate must effectively manage their team in the following areas;
Support and/or lead identification and implementation of near and long term changes including; analyzing and solving process performance problems, root cause analysis, and ownership/sponsorship of CAPAs.
Support and/or lead a variety of capital and expense projects ranging from design, implementation, and startup. Develop solutions to complex problems which may require highly innovative and ingenious approaches.
Develop scopes, URS's, RFP's, budgets, and timelines to communicate requirements to team members, senior management, contractors, and vendors.
Who You Are
Requirements:
- Minimum of 10 plus years in a pharm/bio industry with the same amount of experience in engineering in a cGMP environment.
- Bachelor's degree plus 3-5 years minimum experience in a supervisory role.
- Demonstrated ability to build and lead strong technical teams and develop technical staff.
- Strong technical understanding of Engineering processes and project management .
- High degree of mechanical aptitude with knowledge of cleaning processes (CIP, COP), sterility principles (SIP), chromatography, viral filtration, TFF, and buffer preparation.
Required Education:
- BSc/MSc degree in Engineering, Biological Sciences, or equivalent experience/education in related field
- PMI certification preferred
- PE - preferred
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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Estimated Salary: $20 to $28 per hour based on qualifications.
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