Site Manager External Manufacturing

The Position

The CDMO Site Manager needs specialized depth and/or breadth of expertise mainly in Biologics Drug Substance manufacturing, but any other technology would be a plus (Small Molecules Drug Substance manufacturing, ADC manufacturing, Fill and Finish Drug Product Manufacturing aseptic or not). Supply chain and project management expertise are also a must.

The Opportunity

• Lead cross functional project teams (JPT) for development programs and/or joint management teams (JMT) for pipeline and commercial products during all/some life cycle phases (i.e. selection, implement/manage and decommissioning) at one or more CDMOs, coordinates steering committees (JSC).

• Be responsible for the execution of development activities, preclinical, clinical and commercial supply.

• Lead/coordinate product transfers and launches at the respective CDMO(s).

• Accountable for all operational CDMO activities: assure product development and routine supply/ clinical supply with production and QC activities during product life cycle and decommissioning, manages budget monitors the CDMO's performance and coordinates risk mitigation activities.

• Evaluate, design, implement and maintain tailored development and manufacturing solutions globally to broaden and accelerate patient access to our medicines in alignment with the product strategy teams and/or the product development teams.

• Consider sustainability aspects for the set ups.

• Establish, coach and lead cross-functional/ international project and governance teams consisting of Roche global functions, Roche local functions and external partner companies. With representatives of e.g. Quality, SHE, MSAT, ASAT, Material Management, Engineering, Validation, Registration, Process Development,Packaging Development, Procurement, Legal, Tax, Pricing, Partnering, Market Development and other functions as appropriate.

Who you are:

• Minimum 10 years of industry experience in the manufacturing of Biologics or other technologies used to make Drug substances or Drug Products.

• 5+ years of project/program management experience in the development, commercialization, and lifecycle management of Drug substances or Drug Products

• Experience in managing the following aspects of pharmaceutical production

• End-to-end global supply chain.

• Product lifecycle changes and product complaints

• Commercialization and launch of innovative medicines

• Demonstrated track record of partnering effectively with R&D,

• Manufacturing, supply chain & distribution, quality and regulatory and working with CDMOs

• Strong interpersonal and leadership skills to effectively communicate and build relationships with a broad spectrum of audiences and organizational levels.

• Sound technical aptitude and proven ability to grasp general knowledge of multiple disciplines to move projects forward.

• Experience in managing Third party suppliers

This position is not eligible for relocation support.

The expected salary range for this position based on the primary location of California is $138,300 to $256,900. 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

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Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.