Executive Director, Formulation & Process Development – Pivotal & Commercial Biologics

Описание вакансии

The Executive Director of Formulation & Process Development (Pivotal & Commercial) (DPD) will be responsible for leading the development and characterization of formulations and drug product processes for biologics programs from the Pivotal and Commercial stages. This responsibility will also include any post launch Life Cycle Management (LCM) development activities. They will also be a member of the Pivotal/Commercial Biologics Technical Development Leadership Team, that is responsible for providing leadership and decisions on the development and commercialization strategies for all aspects of late-stage process development (Cell Culture, Purification, Drug Product, Analytical Sciences, MSAT, and Materials Sciences). 

Responsibilities: 

• Provide leadership and direction to the Biologics Drug Product Development organization, a department of scientists and engineers 

• Accountable for development and characterization of robust formulations that deliver to phase appropriate Target Product Profiles (TPPs) and drug product processes (fill finish?) 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. 

• Support regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections 

• Partner with cross functional members across Gilead Pharmaceutical Development & Manufacturing (PDM), including Quality, Supply Chain, Manufacturing, Regulatory Affairs CMC, Finance and Technical Development to ensure successful commercialization of the late-stage portfolio, as well as on time delivery of clinical and commercial product. 

• 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. 

• Serve as a member of the Biologics Pivotal/Commercial Technical Development Leadership Team responsible for developing and establishing late-stage Biologics strategy 

• 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. 

• Establish goals that are consistent with the portfolio & functional priorities and ensure the right balance between near term and longer-term objectives to position the organization for sustained success through tangible capability improvement 

• Hire, mentor and develop team members within the organization to help build and grow a world-class Biologics Drug Product organization 

• Develop and manage department budget 

Qualifications: 

• Ph.D. or M.S. in Chemical Engineering or relevant scientific discipline with at least 15 years of experience in formulation and drug product development and a record of roles with increasing responsibility and track record of progressing portfolio assets from INDs to MAAs. 

• Strong understanding and extensive hands‐on experience in drug product process development. In-depth knowledge and deep understanding of formulation development, fill/finish process engineering, particle mitigation and characterization, in-use compatibility studies and pharmacy manuals, and single use and stainless systems. In-depth knowledge of industry best practices & trends. 

• Proven experience in the generation of relevant regulatory sections of IND, BLA and MAA filings. 

• Previous success working effectively in a multidisciplinary, highly matrixed environment 

• Demonstrated ability to build a team and develop a high performing organization 

• Excellent decision-making, written and verbal communication skills 

• Proven ability to lead high performing teams 

• Exceptional interaction, leadership and command skills are required 

• Motivated self-starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation, and scientific writing skills. Strong self-awareness of the impact communication and working style has on others. 

• Exceptional influencing, partnership, and collaboration skills and ability to drive results within a matrix environment. Demonstrated eminence in the scientific community, with desire & ability to shape industry standards. 

• Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, stakeholder management, cross-functional engagement and influence, program management, strategic vision, executive presence. 

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) 

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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 careers@gilead.com for assistance.