The Learn & OE Partner is an integral member of the Clinical Supply Center (CSC) team in South San Francisco (SSF). The SSF CSC is designed to be a state-of-the-art large molecule drug substance facility which supports GMP production for phase 1, 2 and early phase 3 clinical trials. The CSC will employ a ballroom design, utilize single-use technology, new analytical techniques and digital manufacturing systems to deliver a best in class bioprocess facility. We are looking for individuals to support this facility who are comfortable with ambiguity, have an entrepreneurial spirit within a GMP environment, have demonstrated strong Pharma Technical Behaviors, and have an agile mindset. Ability to collaborate is crucial as success will be measured as a member of a team, not just as an individual. Ideal candidates would have experience in a broad range of functional roles in support of biopharmaceutical production.
In this role the qualified individual will initially be part of the CSC project team and will then continue in a role in support of the facility. The candidate will establish relationships with customer groups, network teams and vendors by seeking opportunities for collaboration, proactively communicating and presenting information and offering relevant data driven information to impact decisions. The candidate will be a member of the Production Support Team and will lead teams and projects, coach individuals across the entire organization and lead by example through their own behaviors. More than one individual may be selected under this overall job description.
The Learning & OE (LOE) Partners will report to the Senior Manager of Learn and OE in Production Support (PS). The candidates will be hired to support the CSC Learn and Operational Excellence team focused on capability building. Candidates are initially expected to have strong technical expertise in one of these areas and will develop additional expertise over time through a combination of role assignments and coaching. The desire is to build a complementary team of contributors with diverse technical backgrounds across all of these areas. The selection of the final candidates will be based on the overall team assembly of a diverse set of strong leadership and technical skills.
This position can be performed remotely for the next approximately 3-6 months, however will gradually transition to require at least partial on-site presence in order to perform the essential project and operational responsibilities of the role. As we transition to "normal" the option to work flexibly should be available as appropriate given business needs and with management endorsement. Responsibilities:
The Learn & OE (LOE) Partner will support the development, implementation and continuous improvement of the learning and operational excellence strategy that connects the needs of the CSC to solutions that strengthen organizational performance. This strategy will leverage the creation of an adaptive learning culture for enhancing capabilities in a personalized, innovation driven, and holistic manner. The learning culture will include the establishment of a learning ecosystem and knowledge management program, where individuals can think systematically through Roche's Lean Production System (seeing and solving problems through analytical thinking), learn from the successes and failures of others, capture and share organizational knowledge, change based on organizational wisdom, enhance coaching capabilities, continuously improve and commit to personal mastery of competencies. The Learn OE Partner has the ability t o integrate strategic connection points across the CSC, to establish standards for high performance with the focus on getting the right information to the right people, in the right amount, at the right time.
The LOE Partner will champion and inspire alignment with network strategies and standards such as Competency Based learning, Cornerstone, and the Lean Production System.As a senior contributor, the LOE Partner is expected to challenge the status-quo and develop creative solutions within the framework of the Global S tandards and processes. They partner proactively with key customers while being open and approachable with a friendly, positive and professional attitude. The LOE Partners will build systems, processes and behaviors which deliver innovation.
- Provide guidance, coaching and context to teammates in order to empower to the greatest degree possible
- Deliver value as measured periodic review with leadership
- Recommend changes and establish business processes within area of responsibility
- Coach and lead teams working on a diverse scope of complex problems and initiatives.
- Make independent decisions having an impact on business unit operations, activities, and project schedules
- Frequent contact with internal and external stakeholders regarding operations, projects or services of team
- Communicate business and technical updates for both internal and external stakeholders
- Applies cross-functional expertise in the context of CSC objectives and must be able to maintain strong partnerships with Manufacturing, Quality, Facilities, Technology, and Global & Network Partners.
- Organizational change agent delivering business results focused on improving business processes to improve reliability, increase simplicity.
- Work is performed under limited direction and guidance, with general instructions on new assignments.
- Exercises independent judgment and discretion on matters of significance more than 50% of the time.
This position requires strong adherence to compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents. . As with any position in a manufacturing environment, the job requires an ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule. Skills and Behavior Profile:
- Strong behaviors aligned with Pharma Technical (PT) expectations including Lean/Agile, inclusion, collaboration, speaking up, decision making and continuous improvement
- Ability to work in an agile and ambiguous environment
- Commitment to quality and excellence
- Growth mindset with a passion for taking on challenges in order to deliver business value while developing
- Entrepreneurial spirit within a GMP environment
- Servant leader with strong coaching skills
- Ability to challenge the status quo in order to deliver value
- B.S. Degree in Engineering or related discipline with 8-11 years of experience in pharmaceutical/biotech or 6-9 years of experience with Master's Degree
- Experience leading in technical or operational function
- Ability to execute complex projects in a GMP environment.
- Understand current GMP requirements and regulations
- Strong strategic thinker
- Possess excellent interpersonal and communication skills
- Strong problem solving and critical thinking skills
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.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.