Senior Director-Biologics Analytical Development Pivotal and Commercial
Senior Director-Biologics Analytical Development Pivotal and Commercial
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$ 243100 - 314600
1 Vacancy
Job Description
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 lifechanging 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
Senior Director in Biologics Analytical Development (Pivotal and Commercial)
Foster City CA
The Senior Director in Biologics Analytical Development (Pivotal and Commercial will be responsible for leading analytical development activities encompassing physicochemical method development and qualification testing of process related impurities and the establishment of analytical testing strategies for drug substance and drug product. Additionally they will be accountable for ensuring that product quality targets and specifications are established based on robust patientcentric considerations throughout pivotal development. Through these activities they will play an instrumental role in ensuring successful regulatory filing strategies.
Responsibilities:
Provide leadership to a group of analytical development scientists
Mentor and guide scientists in their roles
Oversee budgeting for capital equipment
Set clear expectations and prioritization of work packages
Manage workload and resources effectively
Accountable for:
Analytical Methods: Development Technical Support to QC validations and transfers lifecycle management
Developing analytical control strategies for drug substance and drug product ensuring patientcentric considerations are incorporated
High throughput analytical testing for drug substance and drug product development
Establish and maintain a stateoftheart analytical laboratory
Guide the authoring review and approval 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 latestage Biologics portfolio
Exhibit comprehensive knowledge of cGMP practices and requirements
Act as a key member of the Analytical Development leadership team to shape latestage 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 stateoftheart analytical technologies and approaches
Set organizational goals that align with broader objectives while balancing immediate and longterm priorities
Recruit hire and mentor talent to help cultivate a world class Biologics AD organization
Qualifications:
Ph.D. with 12 years or M.S. with 15 years in Analytical Chemistry or related fields of industrial experience in biologics analytical development with people leader accountabilities.
Extensive experience with analytical method development and control strategies of biologics products.
Well versed in separation techniques (e.g. UHPLC CESDS iCIEF) commonly used for biologics analytical development
Subject matter expert in establishing comprehensive control strategies for biologics products
Expertise in the development/qualification of various assays including for purity and process related impurities
Wellversed in high throughput assay methodologies including automation
Well versed in FDA and ICH guidelines relating to registration quality and compliance concerning drug substance and drug product.
Proven track record in drafting regulatory documentation at all stages including IND BLA and PAS filings.
Demonstrated ability of building strong collaborations with other CMC functions.
Strong business acumen with ability to balance resource budget and program milestones.
Working knowledge of lab automation computer validation data governance data science knowledge management and data protection.
Leadership qualities of the successful candidate include the following: collaboration building and developing high performing teams accountability cross functional engagement and influence program management strategic vision executive presence. Ability to build high performing teams and to set clear and measurable goals for staff and prioritize projects and resources.
Create Inclusion knowing the business value of diverse teams modelling 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 organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
Gilead Core Values
Integrity (Doing Whats Right)
Inclusion (Encouraging Diversity)
Teamwork (Working Together)
Excellence (Being Your Best)
Accountability (Taking Personal Responsibility)
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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 nonjob 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 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
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.
Required Experience:
Exec
Employment Type
Full-Time
