Senior Manager, Global External Manufacturing- Sterile DP & Biologics

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

AtGileadour pursuit of a healthier world for all people has yielded a cure for hepatitis C revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the worlds most devastating diseases united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to a Senior Manager Global External Manufacturing at Gilead you will support the uninterrupted supply of Gileads clinical and commercial products through execution of manufacturing campaigns within our global external contract manufacturing network while ensuring compliance with cGMP regulatory requirements and environmental health and safety legislations.

This position is part of the Manufacturing Operations group within the larger Pharmaceutical Development and Manufacturing organization (PDM). Experience in leading the Manufacture of Sterile Drug Products is a must.

This role requires collaboration at the Team Leadership level with the Development Quality Regulatory Analytical Supply Chain and Product & Portfolio Strategy organizations within PDM to ensure successful technology transfer commercialization launch routine supply and proactive management of changes across the product lifecycle.

This position will be based at the Gilead Foster City campus

Functions:

• Accountable for the execution of the tactical manufacturing strategy and all technical/operational activities related to maintaining clinical and commercial product supplies through management of external resources.

• Accountable for the technical lifecycle management of commercial products including both intra and inter technology transfers scale-up process validation and continuous process validation.

• Provides technical expertise in parenteral manufacturing unit operations including; thawing compounding filtration aseptic filling lyophilization capping terminal sterilization visual inspection and sterility assurance.

• Co-leads commercialization activities at external partners for new products in conjunction with the process development team. Provides support for process development activities at external partners.

• Leads and coordinates the Gilead cross functional CxO team.

• Leads activities at manufacturing sites including providing project timelines resolving issues on-site troubleshooting and providing overall technical support; may negotiate pricing for limited-scope projects.

• Leads technical investigations and assessment of deviations and CAPAs.

• Defines requirements for and reviews master batch records and change controls.

• Coordinates equipment/process qualification (IQ/OQ/PQ) and executes process validation (PV); writes reviews and/or approves qualification/validation/technical reports.

• Responsible for the development distribution updating and maintenance of the technical database for all CMOs currently used by the company in the manufacturing of commercial products.

• Responsible for tracking and updating senior management on the routine manufacturing of commercial products providing guidance on potential problems and their resolution.

• Supports the product CMC team as the sitting manufacturing representative. Authors documents for Regulatory filings and review filings including sections from other disciplines. Responsible for the technical review of pertinent CMC sections of global regulatory filings.

• Manages complex processes across functions and interacts effectively with the other team members to ensure product meets regulatory performance and cost requirements.

• Provides technical guidance and training to junior group members.

Experience:

• Experience in sterile drug product manufacturing and supply chain execution and oversight in the pharmaceutical industry

• Experience in supply risk management. Possesses knowledge of industry and system best practices

• Experience and/or working understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP)

• Solid knowledge of worldwide regulatory requirements including pharmaceutical ICH guidance

• Understanding of the contract manufacturing organization (CMO) landscape

• Knowledge of CMO capabilities and limitations for worldwide bulk drug substance manufacturing is a plus

Requirements:

• 8 years of progressively responsible experience in a pharmaceutical/biotech organization and a BA or BS degree in science or engineering required OR

• 6 years of progressively responsible experience in a pharmaceutical/biotech organization and a MS degree in science or engineering required OR

• 2 years of progressively responsible experience in a pharmaceutical/biotech organization and a PhD in science or engineering required

• Exceptional verbal and written communication skills

• Sound organizational and time management skills

• Ability to effectively manage multiple priorities

• Working knowledge of GMPs and associated regulations

• May participate and support QA in audits.

• Ability to interact effectively with senior management

• Ability to travel internationally including overnight up to 10% of the time is required

People Leader Accountabilities:

• Create Inclusion -knowingthe business value of diverse teams modeling inclusion and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills experience aspirations and potential of their employees and coach them on current performance and future potential. They ensure employeesare receivingthe feedback and insight needed to growdevelopand realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals purpose and organizationalobjectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other non-job related characteristics or other prohibited grounds specified in applicable federal state and local order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections please view theKnow Your Rights poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.