Job Description

Site Head Manufacturing - Holly Springs, North Carolina, US

Who we are

At Roche, 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, weve become one of the worlds leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients lives. We are courageous in both decision and action, we believe that good business means a better world.

To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PT will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina.

The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products). Quality, reliability and performance are of supreme importance to us.

Primary duties & Responsibilities:

• Investment and start-up project User Team leadership during the design, engineering, construction and ramp up phase of the site

• Tech transfer and registration of site and first products

• Accountable for all manufacturing and related industrial activities at Holly Springs Drug Product Technical Operations including staffing, manufacturing, engineering, validation, facilities, technology, supply chain, warehousing, Environmental Health & Safety (EHS) and operational excellence.

• Ensure the safe, GMP-compliant, quality efficient and cost-effective manufacturing of our Companys drug substance

• Serve as a member of the PTM Leadership Team and play a key role in defining and implementing the PTM networks vision, strategy, objectives and plans

• Contribute to the success of the PTM network via active engagement, communication, collaboration and candid contributions

Job Accountabilities:

Right to operate:

• Enable, obtain and maintain the sites Right to Operate (operating license) in-line with global Health Authorities requirements

• Motivate the site team to achieve a high level of integration/collaboration, across all functions and project teams

• Drive implementation of innovative technologies enabling efficient processes and continuous improvement by making the best use of information derived and analysed from Deviation and Investigation Reporting, Right First Time tracking, Basic shop floor data, Customer Complaints, Risk Assessments, GMP assessments, audit findings, etc.

Quality Supply to Patients:

• Accountable for delivering the registration and launch of the first products brought to the new site within the planned project timeline

• Accountable for establishing a high service level of quality drug product and finished goods manufactured in full compliance with current Good Manufacturing Practice (cGMP) and safety regulations

• Attentive to the needs of internal and external customers

People and Leadership:

• Recruit, retain and develop the best possible people for the site, by leveraging Roches people leadership commitments

• Lead, role model and demonstrate PT behaviors

• Engage and coach site staff to achieve excellence in execution by creating a sense of community, excitement and by rewarding superior performance

• Promote employee engagement, diversity and an open two-way feedback culture

• Serve as an active member of PT leadership communities beyond the site

Safety and Environmental Protection:

• Ensure that all applicable safety, health and environment requirements are fulfilled to comply with corporate group policy and local legal requirements

• Actively contribute to the Roche Environmental Health & Safety (EHS) priorities

Contribution to Target:

• Continuously seeks opportunities for improving the sites operating efficiency

• Ensure a high level of planned predictable performance at the site via the appropriate deployment of plant, people and financial resources

• Responsible for developing plans, operating and capital budgets to deliver current requirements, as well as to prepare the site for the requirements in the mid-term (e.g. 5-year) horizon

• Demonstrate appropriate fiduciary (legal and ethical trust) control

Represent Roche:

• Develop and implement strategies for community relations. Acts as a Roche spokesperson and liaison to local communities

Who you are

Qualifications / Requirements:

• Masters Degree (life sciences, engineering or business disciplines preferred). Graduate Degree is preferred (life sciences, engineering or business disciplines preferred)

• 10+ years of related professional experience in the biotech or pharmaceutical industry (manufacturing, quality, supply chain, engineering, project management, facilities management, operational excellence, etc.). Multidisciplinary experience strongly preferred

• Strong senior leader with a proven track of previous people and project management experience. Experience managing cross-functional operations and staff. Several years experience managing direct and indirect reports. Previous managerial experience includes leading and overseeing a large workforce (>100 individuals)

• Peptide sterile fill & finish as well as device assembly manufacturing management experience at a senior level is strongly preferred

• New product launch experience

• Experience planning, leading and overseeing large capital and start-up projects (ideally with the biotech, pharmaceutical or related industry)

• Proven track record in successfully leading processes and other continuous improvements

• Considerable previous experience successfully interacting with management at all levels, across the enterprise.

• Clear and concise communicator, willing to take a stand and intelligent informed risks.

• Strongtrack record in consistently applying appropriate business judgment and decisions

• English language proficiency is a must

Travel Requirements

• Ability to travel domestically and internationally (15-25%)

Relocation benefits are available for this posting

The expected salary range for this position based on the primary location of South San Francisco- Off Campus is $310960.00 and $408135.00. Actual pay will be determined based on experience, qualifications and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance, as well as participation in a long-term incentive program. This position also qualifies for the benefits detailed at the link provided below.

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 .

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