Senior Associate, External (Outsourced) Manufacturing, (OSD)

Biopharma Careers; Foster City (CA); On-site; USD 118,000 - 153,000; Full time

Benefits offered by this job

Medical insurance

Stock-based incentives

Bonus opportunities

Paid time off

Job summary

Gilead Sciences Inc. in Foster City is seeking a Senior Associate, Global External Manufacturing (Oral Solid Dosage) to ensure uninterrupted supply through manufacturing campaigns within our external contract manufacturing network, while complying with cGMP and safety standards.

You will collaborate with Development, Quality, Regulatory, and Supply Chain to enable tech transfer, commercialization, launch, and lifecycle management, and you will coordinate CMOs and transfers.

Qualifications

• BA or BS in science or engineering plus 5+ years of experience in pharmaceutical/biotech manufacturing or MS/MBA with 2 years of relevant experience.
• Experience in drug product manufacturing and supply chain execution in pharma.
• Experience with cGMP and regulatory requirements.

Responsibilities

• Execute network strategy within Global External Manufacturing.
• Manage external supplier performance and CMOs.
• Collaborate with Development, Quality, Regulatory, and Supply Chain for product lifecycle.
• Coordinate inter/intra-company tech transfers and validation with CMOs.
• Oversee deviations, investigations, and change control to ensure compliance.
• Drive continuous improvement to reduce cost and improve quality.
• Serve on cross-functional teams for life-cycle product strategy.

Skills

Pharma manufacturing

Supply chain execution

cGMP knowledge

Education

BA/BS in science or engineering

Tools

CMO landscape

Job description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve 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 world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s 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 we’re 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

Senior Associate, Global External Manufacturing, (Oral Solid Dosage) works to ensure uninterrupted supply of Gilead’s 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). This role requires collaboration 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.

Responsibilities

• Responsible within Global External Manufacturing to execute the network strategy.
• Responsible for tactical execution of the business with external manufacturing organizations, and management of supplier performance
• Effectively collaborates with functions within and external to PDM to achieve corporate, cross functional, and departmental goals.
• Responsible for coordination of inter- and intra-company technical transfers. Partners with Technical Development and internal Gilead manufacturing sites for successful technology transfer and validation of new or existing processes/products to the identified CMO(s)
• Executes the regular, tactical management of CMOs to ensure Gilead’s products are manufactured in accordance with the registered process and approved Master Production Record
• Enables timely resolution of issues associated with manufacturing and/or compliance, including handling of deviations complaints, out-of-specification investigations, Material Review Board associated investigations, finished product trending, and change control
• Fosters and facilitates continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability.
• May represent manufacturing on one or more cross-functional Development or Commercial CMC teams with responsibility for proactively managing product strategy across the life cycle from clinical supply to commercial product launch and routine supply, and then to sunset or divestiture

Basic Qualifications

• BA or BS degree in science or engineering and 5+ years of progressively responsible experience in a pharmaceutical/biotech organization. OR MS or MBA degree may be substituted for 2 years of relevant experience
• Experience in drug product manufacturing and supply chain execution and oversight in the pharmaceutical industry
• Experience and/or working understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP).

Preferred Qualifications

• Working knowledge of worldwide regulatory requirements, including pharmaceutical ICH guidance
• Knowledge of the contract manufacturing organization (CMO) landscape; knowledge of CMO capabilities and limitations for worldwide drug product manufacturing is a plus
• Ability to travel internationally, including overnight up to 20% of the time is required
• Exceptional verbal and written communication skills, including ability to interact effectively with senior management at Gilead and contract manufacturing organizations.

The salary range for this position is: $117,895.00 - $152,570.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* 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 disability,genetic 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 laws. In 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 [e-mail] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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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.

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