Manager, Clinical Manufacturing

For 30 years, Genentech has been at the forefront of the biotechnology industry, using human genetic information to discover, develop, commercialize and manufacture biotherapeutics that address significant unmet medical needs. Today, Genentech manufactures and commercializes multiple biotechnology products that have helped patients suffering from serious diseases and conditions, including breast cancer, colorectal cancer, non-Hodgkin's lymphoma, lung cancer, rheumatoid arthritis, cystic fibrosis and allergic asthma. The company is the leading provider of anti-tumor therapeutics in the United States.

Our continued growth has created an opportunity for a Manager, Clinical Manufacturing in our Oceanside, CA facility. Please take this opportunity to learn about Genentech, where the creativity and openness of an academic environment meet the rigorous dedication of industry-leading professionals focused on improving and extending people?s lives.

Responsibilities:
The candidate will lead the Cell Culture Department of the Oceanside Clinical Manufacturing Operations Division. He/she will lead start-up efforts in this area, including hiring and training of staff and establishing departmental procedures. The candidate will ensure consistent and sustainable departmental operations. He/she will develop and/or improve departmental capabilities in response to clinical production demands, corporate needs, industry practices and regulatory agency expectations. He/she will provide multi-site activity coordination and issue resolution across the Clinical Manufacturing Operations Division, other groups and/or projects as needed. The incumbent will manage the development and implementation of novel approaches to solving complex technical problems while maintaining required levels of safety, quality (including regulatory compliance) and production. He/she will interpret and support the defense of Fermentation Operations policies and activities to regulatory agencies.

Requirements:
A B.S./B.A. in Life Sciences, Physical Sciences, Engineering or an equivalent field with a minimum of 10 years of relevant bio/pharmaceutical experience is required. Significant functional group management experience in a clinical manufacturing environment is required. Graduate-level course work, including management training, such as a MBA, is favorable. The candidate must possess strong interpersonal, communication and problem solving skills. Leadership, teamwork, multi-tasking and technical expertise skills are essential. He/she must be flexible and adaptable with the ability to interact with PD staff. Experience building an organization, as well as start-up manufacturing experience, is preferred. Working knowledge of safety, quality systems and quality assurance concepts is required, including the application of current Good Manufacturing Practices (cGMPs). Familiarity with Cell Culture manufacturing processes and operations, industrial automation (such as distributed control and PLC-based systems), equipment/facilities validation, analytical techniques and experimental designs used for process validation is required.

Genentech offers one of the most comprehensive benefits packages in the industry. Join a company that attracts, retains and rewards talented and committed employees. Our culture emphasizes working hard, collaborating and sharing rewards. For immediate consideration, please visit www.gene.com/careers and reference Req. #1000013198. Genentech is an equal opportunity employer.