Senior Director, Purification Process Development – Pivotal & Commercial Biologics

Description

Senior Director, Purification Process Development Pivotal & Commercial Biologics

The Senior Director of Purification Process Development for Pivotal and Commercial Biologics will be responsible for leading the development and characterization of purification processes for multiple biologics programs during the Pivotal and Commercial stages.

This responsibility will also include post launch Life Cycle Management (LCM) development activities and regulatory strategy for Gilead’s biologics entities.

They will also serve as a site lead for the Pivotal and Commercial Biologics Purification Department. This role is expected to work collaboratively with cross-functional stakeholders and contribute to the overall biologics CMC development strategies.

Responsibilities :

• Hire, mentor and develop team members within the organization to help build and grow a world-class Biologics Purification Process Development organization.
• Establish and maintain state-of-the-art purification labs that enable efficient development and process characterization of biologic purification processes.
• Provide leadership and oversight for multiple pivotal and / or commercial biologic programs.
• Accountable for development and characterization of robust purification processes to support Pivotal clinical and Commercial manufacturing, including Life Cycle Management.

This includes accountability for developing an integrated control strategy in partnership with organizations across Technical Development, Quality, Regulatory Affairs CMC, and Manufacturing.

Lead purification process development and transfer to internal and contract manufacturing facilities to produce GMP and non GMP drug substances on time and with high success rate.

Oversee data generation / data integrity to ensure compliance. Lead manufacturing atypical event investigations.

• Support regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections.
• Ensure strong relationships with key stakeholder functions including Research, Clinical Development, and Clinical Supply Management and Product Strategy Teams by providing technical and strategic input.
• Demonstrate a knowledge of the cGMP practices and compliance requirements.
• Drive development and implementation of new process technologies to meet business and portfolio needs.
• Remain current on trends and new technology advancements across the Biopharmaceutical industry.

Qualifications :

Ph.D. in Chemical Engineering, Biochemistry, or related fields with 10+ years’ experience OR M.S. with 12+ years’ experience OR B.

S. with 14+ years industrial experience in biologics purification development with people leader accountabilities.

• Extensive experience in pivotal development, process characterization and commercial support of harvest, chromatography, TFF and viral filtration operations.
• Demonstrated experience in process transfer to manufacturing facility and technical leadership in process troubleshooting.
• Well versed in FDA, EMA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and authored CMC sections in commercial filings (BLA, MAA) and post approval changes.
• Working knowledge in lab automation, data science, knowledge management, single-use manufacturing technology and cGMP guideline is a plus.
• Strong business acumen, be able to balance resource, budget and program milestones.
• Leadership qualities of the successful candidate include the following : collaboration, building and developing high performing teams, accountability, cross functional engagement and influence.

Ability to build high performing teams and to set clear and measurable goals for staff and prioritize projects and resources.

People Leader Accountabilities :

• 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 What’s Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)

The salary range for this position is : $237,660.00 - $307,560.00. 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 :

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

For jobs in the United States :

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 for assistance.