Director, Biologics Analytical Development (Pivotal and Commercial)

Director, Biologics Analytical Development (Pivotal and Commercial)

Join to apply for the Director, Biologics Analytical Development (Pivotal and Commercial) role at Gilead Sciences

Director, Biologics Analytical Development (Pivotal and Commercial)

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Join to apply for the Director, Biologics Analytical Development (Pivotal and Commercial) role at Gilead Sciences

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 Description :

We are seeking a talented and highly motivated Director for our Structural Characterization team in Biologics Pivotal and Commercial Analytical Development. Broad experience in analytical development from early development to commercial launch, filing experience with FDA / EMA, and in-depth technology understanding for biological products are the key in this role, which will expand our rapidly growing Foster City team. A solid understanding of GMPs and CMC requirements is expected. Mass Spectrometry expereince is a must.

Responsibilities

• Provide leadership to a group of structural characterization scientists, including :
• Mentor and guide scientists in their roles.
• Set clear expectations and prioritization of work packages.
• Recruit and hire new talent.
• Accountable for :
• Defining critical quality attributes (CQAs) across the late-phase biologics portfolio and building deep understanding of how CQAs relate to the products function.
• Driving continuous improvement of CQA identification strategies.
• Leading innovation in mass spectrometry initiatives to build a best-in-class structure characterization function.
• Leading higher order structure deliverables across the late-phase portfolio.
• Support the design / justification / execution of end-to-end control strategy development through a proactive definition of the product quality targets.
• Delivering high quality structural characterization work packages for supporting Pivotal INDa and marketing applications.
• Serve as an analytical project lead (ASTL) for late-phase program overseeing all analytical deliverables.
• Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies.
• Collaborate across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ensure timely delivery and successful commercialization of the late-stage Biologics portfolio.
• Act as a key member of the extended Analytical Development leadership team to shape late-stage development strategies.
• Demonstrate comprehensive knowledge in key analytical CMC strategic areas including CQAs, separations methods, method bridging, reference standard, comparability, and specifications.
• Drive for the adoption of novel and state-of-the-art structural characterization technologies and approaches. Recruit, hire, and mentor talent to help cultivate a world class Biologics AD organization.

Basic Qualifications

or

Preferred Qualifications

People Leader Accountabilities

The salary range for this position is : $226,185.00 - $292,710.00. 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

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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 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 ApplicantAccommodations@ for assistance.

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

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PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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.

Seniority level

Seniority level

Not Applicable

Employment type

Employment type

Full-time

Job function

Job function

Other

Industries

Biotechnology Research and Pharmaceutical Manufacturing

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