Head of Manufacturing, Gene Therapy

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

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.

The Opportunity

The Head of Gene Therapy Manufacturing will be responsible for leading the PTC Gene Therapy Manufacturing Organization. This individual will oversee the manufacture of clinical and commercial drug substance and collaborate with the broader PT organization to deliver Drug Product through both in-house manufacturing and external manufacturing partners. This position will be responsible for the expansion of Roche's gene therapy manufacturing capabilities through key investments (GTIC) and partnerships with CDMOs. Additionally, the incumbent will be responsible for MSAT, Facilities and Site Engineering, Digital Systems and Materials Management.

What You'll Do

The Head of Gene Therapy Manufacturing will be responsible for leading the PTC Gene Therapy Manufacturing Organization. This individual will oversee the manufacture of clinical and commercial drug substance and collaborate with the broader PT organization to deliver Drug Product through both in-house manufacturing and external manufacturing partners. This position will be responsible for the expansion of Roche's gene therapy manufacturing capabilities through key investments (GTIC) and partnerships with CDMOs. Additionally, the incumbent will be responsible for MSAT, Facilities and Site Engineering, Digital Systems and Materials Management.

This individual will be a part of the PTC Leadership team and play a key role in developing, shaping and implementing the overall technical strategy in the Cell & Gene Therapy space. They will advise and influence senior management on best practices and define and develop short, medium, and long-range manufacturing planning to support PTC's global strategic vision.

The Manufacturing Organization comprises Manufacturing Operations, MSAT, Facilities/Engineering, Digital Systems and Materials Management. This individual will work collaboratively with other departments within the PTC Organization and the Roche Network.

They are accountable for ensuring both Manufacturing and Warehouse facilities are maintained in a constant state of inspection readiness, and all staff are compliant with cGMP and all related elements.

They will provide leadership and direction for all aspects of the Manufacturing functions for Regulatory licensure activities, including representing their areas of responsibility during Health Authority inspections and formulation of inspection responses. They will oversee Manufacturing investigations, CAPA, process variances and deviations and ensure that all Manufacturing owned change control, CAPA, and deviations are completed by the due date.

They will develop, implement, manage and report all metrics relative to the successful and timely accomplishment of assigned goals, objectives, and projects.

They will manage headcount and participate in setting the organization's annual budget and quarterly forecasting processes. They will effectively recruit, retain, develop, and lead a team of professionals.

They will establish, track, communicate, and sustain metrics to monitor Manufacturing performance and compliance and report and present metrics in management meetings.

Working in partnership with the PTC Leadership Team, they will develop and lead the design effort for the Manufacturing areas of any new renovations to existing facilities and any new construction projects for future facilities including the implementation of paperless systems, automation and digitization. The Head of Gene Therapy Manufacturing will lead the PTC Gene Therapy Manufacturing Organization, overseeing the manufacture of clinical and commercial drug substance and collaborating with the broader PT organization to deliver Drug Product through both in-house and external manufacturing partners. This position will expand Roche's gene therapy manufacturing capabilities through key investments and partnerships with CDMOs.

Who You Are

Minimum of 20 years experience as a leader of Manufacturing Operations in a Biotechnology or Pharmaceutical manufacturing organization. Large molecule or vaccine manufacturing experience required.

Bachelor's degree required, graduate degree preferred, in chemical engineering, biochemical engineering or biological sciences required.

Comprehensive understanding of cGMP requirements for clinical and commercial pharmaceutical manufacturing & supply management globally.

Demonstrated experience leading global commercial cGMP manufacturing operations required.

Experience in supporting global filings and a successful history in completing pre-approval and post licensure inspections globally.

Experience in new site construction and establishment of new operations organization required.

Experience in the implementation of paperless batch records, MES solutions and utilization of distributed control systems.

Experience with Six Sigma Best practices to support a culture of Operational Excellence.

Experience with working in a cGMP Warehouse environment.

Setting Strategy

Demonstrates a long-term perspective that extends beyond the immediate initiatives; visualizes and articulates a clear direction for Spark during times of uncertainty.

Intellectual curiosity and dedication to science, innovation, and complex problem-solving.

Commitment to strategic priorities and an increasingly aligned and disciplined organizational strategy.

Executing for Results

Focuses on how things are done as much as what is done; drives a culture of high performance with increased attention to discipline and process.

Sets aspirational goals to take organizational performance to the next level, reinventing the operating model when appropriate; goes beyond conventional performance benchmarks to set world class best practice.

Navigates change and uncertainty; is agile in responding to feedback from within and outside the organization.

Makes decisions of a complex nature and to work with other disciplines to obtain the necessary input to ensure a positive outcome from the decision. These decisions will have significant ramifications to the overall success of the organization as well as the Spark's ability to meet the needs of its customer base and patients.

Leading Teams

Able to learn from colleagues, embraces perspectives

Thoughtfully leads through influence and maintains focus on larger priorities; delegates effectively while managing performance and holding direct reports accountable.

Maximize use of team strengths while continuing to develop them, and foster a collaborative environment to insure effective, constructive relationships between internal and external partners.

Identify the required resources and expertise, implement the appropriate team/departmental structures, and establish the required processes and communications to enable department(s) to effectively deliver on all commitments.

Building Relationships and Using Influence

Collaborates and looks to support other leaders; sees value in championing the work of the group over the individual.

Offers enthusiasm and empathy toward other leaders and their respective departmental goals; influences and ensures alignment toward common priorities.

Able to connect, engage in open dialogue, disagree when necessary, and compromise toward the greater good of Roche.

Other Job Requirements

Requirement to work some weekends and off hours, depending on project schedules

Minimal travel requirements

The expected salary range for this position based on the primary location of Philadelphia, PA is $247,400 - $459,400. 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.

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