Sr Manager, Technical Services

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.

Job Description

This role will provide the strategic interface between the clinical manufacturing project execution team and the commercial manufacturing business unit to ensure the execution of the new product introduction activities are aligned to required timelines

Core responsibility to ensure the planning and execution of the new product introduction activities are aligned to the strategic vision and timelines for project including:

• Leads a Matrixed team of personnel organizing and executing project activities to ensure successful introduction of the product to the site
• Responsible to ensure the new product introduction strategy and scope is aligned to the needs of the business.
• Provide supervision of technical transfer activities associated with the new product introduction including project documentation creation and execution e.g. Technology Transfer Protocol and project task execution
• Ensure all element of the new product introduction project are delivered on time within the stipulated scope and budget.
• Managing relationships between clinical manufacturing team receiving business unit and external parties such as formulation process development FPD
• Coordinate project updates to senior management where needed.

The role will also support Commercial Product Life Cycle Activities on site including project management and technical transfer activity including:

• Act as the primary technical interface between Development Manufacturing Quality Regulatory and Supply Chain teams for NPIs and ongoing product support.
• Define and implement control strategies for new and existing products ensuring robust process performance and compliance with cGMP and regulatory requirements.
• Lead technical investigations of process deviations complaints and out-of-specification results ensuring timely resolution and effective root cause analysis.
• Develop and review master batch records user requirement specifications and validation protocols for new and existing products.
• Provide expert technical support for troubleshooting process optimisation and the introduction of new technologies or analytical methods.
• Liaise with contract manufacturers and external partners to ensure successful technology transfer and product launches.
• Support the preparation and review of regulatory submissions and responses related to NPIs and commercial products.
• Mentor and develop team members supporting their career growth and technical development.
• Ensure all activities comply with health safety and environmental regulations and company policies.

Knowledge Experience and Skills

• Demonstrates in-depth knowledge of manufacturing principles concepts industry

• Practices and standards (i.e. Technical Transfers Process Validation Execution)

• Extensive experience and BS or MS or PhD degree in a relevant scientific discipline.

• Demonstrates excellent verbal written and interpersonal communication skills.

• Demonstrates ability to interact with senior management.

• Demonstrates ability to participate in highly effective teams.

• Demonstrates ability to think critically and creatively be able to work independently and to determine appropriate resources for resolution of problems.

• Demonstrates strong organizational and planning skills

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.