Senior Director, Drug Substance (DS) - CSC Operations, Process Support, and Process Engineering

Genentech•South San Francisco, CA

35d

About The Position

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Inclusion and Belonging are critical to the success of our company and our impact on society. We believe that by championing unique backgrounds, thoughts, and experiences, 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. The Opportunity The Senior Director of Drug Substance CSC operations, process support, and process engineering is accountable for the safe, efficient, innovative, and cost-effective operation of their function spanning one or more areas of responsibility within the DS Clinical Supply Center (CSC), while maintaining full compliance with current Good Manufacturing Practices and Roche's corporate policies. The scope encompasses cell culture and purification operations, solution preparation, analytical testing, process engineering and troubleshooting, and process technology transfer support. Some of these responsibilities will be fully contained within the CSC, and others may have accountability within, but execution by internal or external partner groups with dotted line reporting into the CSC. This position sets vision, strategies, policies, and standards to ensure clinical trial demands are met safely. The leader must collaborate with peers and partner groups to deliver industry-leading clinical supply timelines and overall value to patients. This leader will build, foster, and maintain a highly engaged workforce and cohesive community where everyone brings their full authentic self to create a stronger whole.

Requirements

20 or more years' work experience in the pharmaceutical or related industry
10 or more years' people and team management experience
5 or more years' work experience in a cGMP regulated environment, preferably in biologics manufacturing
Expert knowledge and experience spanning multiple Technical Operations functional areas, such as Operations, MSAT, Materials Management, Facilities & Engineering, Process Development, Quality, Supply Chain, OE, Planning & Scheduling, etc.
Expert knowledge of cGMP regulations and expectations relevant to the pharmaceutical industry
Bachelor's Degree required (science or engineering is preferred)

Nice To Haves

Professional, Graduate, or higher-level degree is preferred

Responsibilities

Work collaboratively as part of the plant leadership team to establish a bold, shared vision and define the function's role within it.
Establish strategic goals and objectives and maintain full strategic responsibility for the function. Accountable for its overall budget and financial performance.
Develop a culture of trust, ownership, and accountability for high performance.
Coach individuals and teams, providing timely feedback to promote a positive Safety Culture, PT Lean Leadership Principles, and cGMP operating principles.
Foster a speak-up culture and role-model a culture of continuous improvement and learning, acting as a visible change agent promoting agility and a growth mindset.
Serve as the escalation point and take accountability and ownership for high impact business, technical, and compliance decisions
Prioritize to create clarity and focus for the function, forming and/or sponsoring teams, networks and systems that enable action.
Develop short and long term functional goals in the areas of safety, quality, delivery, engagement, and cost. Manage the business to deliver on commitments and optimize performance of the function over time.
Ensure cGMP production of products in compliance with all applicable global Health Authority requirements and Roche PQS standards.
Maintain inspection readiness and represent the CSC to global Health Authorities as part of regulatory submissions and inspections.
Ensure that staff are appropriately trained and qualified for the activities they perform.
Monitor relevant technical and business environment trends and adjust strategies.
Foster a culture of technical excellence and innovation.
Be a voice and ambassador of the CSC, representing the function on key teams and initiatives both internally and external to Roche.
Maintain an end-to-end view of the business and use this understanding to effectively balance competing priorities and drive for the best overall outcome for the business and patients.
Understand key risks to worker safety, product quality, and business continuity. Develop business continuity and risk mitigation strategies and take informed action to bring risks to acceptable levels and escalate unacceptable risk profiles.