Director of Manufacturing Operations, 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

Roche Pharma Global Technical Operations (PT) delivers a fast evolving portfolio of new Cell & Gene Therapy (CGT) products to bring new curative treatments to patients. This portfolio of new products comes with the great promise to bring unprecedented medical advances to patients but also presents unique challenges as the regulatory landscape is evolving very quickly.

In this position the Director of Manufacturing is responsible for overseeing the end-to-end manufacturing operations for gene therapy products, ensuring compliance with cGMP regulations, quality standards, and operational efficiency. This role will lead a team responsible for clinical and commercial production and will support technology transfer and continuous improvement initiatives to deliver the company's gene therapy pipeline. This role is responsible for oversight and management of manufacturing operations. This role is responsible for ensuring both Manufacturing and Warehouse facilities are maintained in a constant state of inspection readiness, including all staff. All Staff must be compliant with cGMP and all related elements including but not limited to facilities, documentation (SOPs and validation protocols etc.), training, reports and records. This person will provide leadership and direction for the Manufacturing functions for Regulatory licensure activities including representing/ensuring representation of their areas of responsibility during Health Authority inspections and formulation of inspection responses.

What You'll Do

Over-see the end-to-end manufacturing operations, from planning/scheduling to execution and batch release, of Spark's commercial and clinical gene therapy products.

• Manage initiation and on-time closure of quality records, including manufacturing investigations, CAPAs, change controls, and deviations.

• Establish, track, communicate, and sustain metrics to monitor manufacturing performance and compliance; report metrics in management meetings as appropriate applying Operational Excellence methodologies.

Ensure regulatory compliance and strategic regulatory activities:

• Guide teams through Regulatory Inspections, while acting as a leader, SME, and coach.

• Review/approve regulatory filings associated with manufacturing activities and products.

• Ensure compliance with cGMP, FDA, EMA, and other global regulatory requirements.

Drive operational excellence and continuous improvement initiatives, focusing on yield optimization process robustness, and efficiency.

Develop and manage budgets, resource planning, and operational goals to align with business objectives.

Recruit, train, and mentor manufacturing staff, fostering a culture of quality, safety, and accountability.

Work collaboratively across Spark's PSO, Tech Dev, and AQC functions to achieve business goals and objectives.

Foster Spark's Culture. Role model the Spark Values. Create an environment where team members thrive by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that "how" they achieve performance objectives is just as important as "what" they accomplish.

Hire & Integrate. Know what skills, experiences and capabilities are needed to achieve current and future business goals. Take an active role in attracting and selecting talents who are inspired by our Mission, Vision and Values. Consciously create a team with diverse backgrounds, experiences, skill sets and perspectives. Help new team members successfully integrate into Spark so they can actively contribute and add value as quickly as possible.

Manage performance. Ensure every team member knows what is expected of them, what it takes to be successful, and how they are progressing. Provide team members with continuous and on-going performance feedback, holding everyone accountable to achieve results while demonstrating the Spark Values. Help team members understand how their work contributes to the overall success of Spark by continuously communicating priorities, decisions and changes; adjusting goals as needed.

Develop people. Understand each individual team member's career goals. strengths and motivators. Partner with employees to identify areas for development, conduct coaching conversations regularly and provide guidance on ways to develop through on the job experiential learning and stretch opportunities.

Who You Are

• Bachelor's/Master's Degree in Biology, Biomedical, Chemistry, or Engineering

• 10+ years of relevant commercial manufacturing experience

• Experience with biopharmaceuticals, cell culture, and viral vector production

• Working knowledge of cGMP and regulatory compliance

• Previous leadership experience required

Key Skills

• Extensive knowledge of cGMP, manufacturing processes, and quality documentation

• Ability to teach improvement concepts

• Strong communication and technical writing skills

• Solve problems and make decisions based on results

• Collaborate with Manufacturing, MS&T, Facilities, Engineering, Quality, and other stakeholders

• Have technical knowledge for decision-making and understand quality impact

• Interact with internal teams and external vendors

Job will require time in the manufacturing cleanroom. Person must be able to do cleanroom gowning and stand for up to 4 hours at a time.

Minimal travel requirements.

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.