Technical Associate Director, Process Technologies and Development

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

Job Responsibilities

• Technical leadership of engineering projects related to aseptic drug product processing facilities and equipment

• Pathfinding in the design optimization and problem solving of complex systems particularly where conventional/established approaches are not appropriate or have not succeeded

• Developing feasible timelines which reflect physics technical and financial constraints deliver high quality robust solutions address desired business outcomes and impact business success

• Apply fundamental engineering principles to the design development scale-up and validation of robust processes for sterile drug product unit operations (e.g. refrigerated/frozen storage and handling of bulk solutions dissolution of APIs pooling and mixing sterile filtration filling pre-filled syringe processing lyophilization and vial capping) for both small molecule and large molecule parenterals

• Serve as a subject matter expert for clinical and commercial drug product processing operations

• Share expertise and provide guidance/mentorship to nurture and develop the skills of talented junior team members

• Reinforce a culture of continuous learning technical rigor data driven decision making and patient-oriented ethics as keys to technical and business success

• Spearhead the establishment and equipping of a state-of-the-art sterile drug product process engineering lab including the procurement and creation of experimental apparatus instrumentation and tools necessary to fulfill the labs deliverables

• Evaluate new/novel and established technologies and/or equipment most appropriate for implementation in aseptic manufacturing of parenteral drug products

• Provide technical leadership for the build out of new clinical and/or commercial drug product manufacturing facilities and manufacturing lines

• Provide technical leadership for facility fit analysis and site selection for drug product clinical and commercial new processes and technology transfers

• Author sections of regulatory documents (e.g. IND NDA IMPD BLA PAS) in support of global regulatory submissions

Knowledge Experience and Skills

• B.S. degree in packaging engineering mechanical engineering chemical engineering or a related scientific field and a minimum of 10 years of pharmaceutical packaging experience are required. A combination of advanced degree(s) with comparable levels of relevant industry experience is acceptable

• Excellent verbal written and interpersonal communication skills are required.

• Must be able to write clear concise and error-free documents.

• Expert knowledge of aseptic drug product manufacturing relevant cGMP standards regulations health authority guidance and health authority expectations in regions including the United States (FDA) and the European Union (EMA).

• Expert knowledge of relevant parenteral drug product pharmacopeial standards (e.g. USP Ph. ).

• Expert knowledge of aseptic drug product manufacturing and process engineering industrial standards (e.g. ISO PIC/S ISPE ISA) best practices and norms.

• Technical leadership experience with respect to parenteral drug products processes facilities and equipment.

• Practical skills building experimental apparatus instrumentation and tools.

• Complex engineering data analysis.

People Leader Accountabilities:

Create Inclusion - knowing the 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 employees are receiving the feedback and insight needed to grow develop and realize their purpose.

Empower Teams - connect the team to the organization by aligning goals purpose and organizational objectives 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.

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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.

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For Current Gilead Employees and Contractors:

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