Drug Product Development Section Lead

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!

The Drug Product Development Section Lead is responsible for providing strategic direction, technical oversight, efficient execution and people management for a team of 8-10 scientists/engineers developing parenteral formulations and drug product configurations in support of clinical development, commercial product launch and line extensions. The incumbent will be a member of the Drug Product Development leadership team and will collaborate with other Section Leads to ensure project resourcing and harmonization of work product within drug product technical development and in accord with the needs of the PT Drug Product network.

Primary responsibilities and accountabilities

The Section Lead will provide leadership and development of staff with strong focus on coaching, continuous improvement, performance management and career development.

The Section Lead will provide technical oversight for the following scope of work:

• Developing formulations & drug product configurations to support preclinical and clinical studies, and commercial launch

• Transferring formulation knowledge to clinical and commercial sites/partners, and supporting production of material as needed

• Performance of process design studies in preparation of regulatory filings

• Authoring regulatory documents and internal reports

• Developing new technologies & innovative approaches in technical development

• Internal and external influencing on pharmaceutical development topics

• Ensure aligned approaches, seamless collaboration and agile execution of global Drug Product Development workplate and strategy

• Serve as an LT sponsor for technical development functional pod(s) and other strategic projects in the department.

• Responsible for the effective integration and prioritization of formulation initiatives, as well as communication and collaboration with other key partners in Research & Early Development, Regulatory, Quality, Manufacturing, and global Pharma Technical Development.

• Partner with the other Pharma Technical Development leaders to provide guidance to technical development teams and ensure that the strategic direction for Drug Product Development is aligned with the rest of the organization.

• Responsible for successful recruitment and development of an exceptional group of scientists and engineers.

Education/Qualifications

• At least 12 years of relevant experience in biopharmaceutical industry, with at least 5 years of people management experience.

• Experience working on departmental senior staff as an essential contributor to project and people decisions.

• Strong technical expertise in pharmaceutical development and readiness to oversee end-to-end pharmaceutical development and associated HA filings.

• Strong leadership skills, with experience in managing groups of scientists and engineers

• Established track record in recruiting and passionately developing world class staff and building effective teams

• Demonstrated ability to initiate, implement and manage change

• Ability to thrive in a culture of enterprise thinking and coaching

• Strong communication and collaboration skills, as well the ability to build and maintain productive relationships with other functional areas

• Working knowledge of regulatory guidelines and industry practices

• Demonstrated ability to lead innovation and drive for results

• A Ph.D. in relevant disciplines is preferred, though candidates without a Ph.D. with commensurate experience will be considered

Experience, Skills and Knowledge

• The leader must be customer focused and have a strong commitment to embracing network talents and working collaboratively to advance Roche portfolio. As such, the leader will foster an environment of collaboration, accountability, and technical rigor in collaboration with the Pharmaceutical Development community. The successful candidate will provide active, visible leadership in advancing organizational capabilities in drug product development.

Values, Leadership and Competencies

• Passionate for people development with a proven track record in developing staff and and high performing teams

• Exceptional people and team management skills

• Demonstrated leadership in managing international or global multi-disciplinary projects or initiatives, with a focus on alignment and driving innovation

• Strategic thinking and problem-solving abilities

• Embraces LEAN principles, VACC, the concepts of collective leadership and the six conditions of ownership

• Excellent communication and interpersonal skills, with proficiency in English

Relocation benefits are available for this job posting.

The expected salary range for this position based on the primary location of South San Francisco, CA is $177,100 - $328,900. 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.