Manufacturing Director/Operations Lead, Single Use Technology (OCN)

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 Manufacturing Director overseeing Single Use Technology (SUT) at Oceanside (OCN) is tasked with formulating the vision, strategic plans, operational policies, and performance standards required for OCN SUT to achieve status as a leading bioprocess production site. In addition, they will be instrumental in establishing best in class technology transfer through the deployment of a uniform fleet model, ensuring consistent parity with other Network SUT sites.

As the OCN SUT is a new facility, this role will build and maintain a highly engaged workforce and cohesive community where everyone brings their full authentic self to create a stronger whole.

The Manufacturing Director will establish relationships with customer groups, network teams, and vendors by seeking opportunities for collaboration, proactively presenting information, and offering relevant data driven information to impact decisions.The candidate will build and lead teams and projects, coach individuals across the entire organization, and lead by example through their own behaviors.

The Opportunity

Leadership & Coaching (Visionary, Architect, Catalyst, Coach):

• Develop, implement, maintain, and improve workforce models that ensure appropriate levels of staff are available to safely manufacture medicines in an efficient manner.

• Ensure execution of validation activities, operations procedures, operator asset care, and other activities deemed necessary to obtain facility licensure.

• Work with the SHE group to perform safety risk assessments, identify potential hazards, and establish programs that ensure a strong safety culture while also fostering environmental sustainability.

• Collaborate with established leadership teams to develop long term strategies for realizing efficiencies of operating multiple facilities on the same campus, integrating elements of process design and talent development while improving overall site culture.

• Connect leaders and technical experts across the site, network and industry to develop procedures and standard work that serves both the site and network, while delivering launch and commercial molecules.

• Promote a speak-up culture. Encourage, accept, and incorporate feedback from all sources.

• Foster a culture of technical excellence and innovation throughout the function.

• Coach individuals and teams. Provide timely and candid feedback, helping everyone build the skills and mindsets they need to succeed together.

• Build, support, and role model a culture of continuous improvement and learning.. Be an active and visible change agent, promoting agility, modeling a growth mindset, and welcoming new opportunities.

• Proactively promote Safety Culture, Lean Leadership Principles, and cGMP operating principles.

Decision Making, Prioritization, and Execution of Work:

• Serve as the production escalation point and take accountability and ownership for high impact business, technical, and compliance decisions.

• Set priorities 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.

Technical:

• Deliver the SUT facility in a manner that protects Roche's license to operate and supply of product to patients

• Fluent in Lean methodology with implementation experience in a manufacturing environment

• Ensure staff are appropriately trained and qualified for activities they perform

• Present to Health Authorities during inspections

• 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/or escalate unacceptable risk profiles

• Develop financial plans and budgets to control spending and continually reduce manufacturing costs

Who You are

• You have a Bachelor's Degree required (science or engineering is preferred). Professional, Graduate, or higher-level degree is preferred

• You have 15+ years work experience in the pharmaceutical or related industry

• You have 10+ years direct or indirect people and team management experience

• You have 5+ years work experience in a cGMP regulated environment, preferably in biologics manufacturing

• Expert knowledge and experience spanning multiple operations functional areas, (ie Operations, MSAT, Materials Management, Facilities & Engineering, Process Development, Quality, Supply Chain, OE, Planning & Scheduling, etc.

• Expert knowledge of cGMP regulations and relevant to the pharmaceutical industry

• Expert knowledge of the operation of pharmaceutical manufacturing facilities

• Knowledge of biopharmaceutical process development

• Experience or knowledge working with Single Use Technologies or modular operations

Locations:

You are local to Oceanside, CA. As a key member of site leadership, this position requires 100% on-site presence to ensure meaningful connections are established and maintained across the organization.

Relocation assistance is available for this position.

The expected salary range for this position based on the primary location of Primary Location California is $140,000 and $260,000 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

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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.