Scientist, Purification Process Development - Pivotal & Commercial Biologics

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. As the Scientist, Purification Process Development - Pivotal and Commercial Biologics, you are responsible for leading and executing aspects of purification development including process development and process characterization at internal or external facilities for Gilead biologics entities during pivotal and commercial development phases. In addition, this role is expected to lead/support projects for purification technology development, platform process evolution, and support of regulatory filings. We are seeking a highly motivated, team-oriented individual to support downstream process development for our rapidly growing biologics pipeline.

Key Responsibilities:

Demonstrates hands-on technical leadership of all aspects of purification process development including chromatography, TFF and depth filtration

Lead the design and development of downstream processes, including design of experiments, process optimization, data interpretation and analysis

Responsible for technology transfer to manufacturing facility and provide technical input and support during manufacturing of drug substances

Author or review GMP or non-GMP technical documentation (development reports, process description, batch records, etc)

Author and review CMC related regulatory sections

Demonstrates technical proficiency and scientific creativity in improving platform technology

Demonstrates ability in communicating ideas, project strategies and results to team members across functional roles/departments

Mentor junior team members on purification process development strategies, experimental design and execution as well as process transfer.

Help to establish and maintain a state-of-the-art purification lab.

Participate in cross functional initiatives as needed.

Adhere to department budget and all training, compliance, and safety requirements.

Ph.D. and 0-2 years of experience in a relevant scientific discipline (biochemistry, bioengineering, chemical engineering, chemistry, etc)

M.S. with 4+ years or BS with 6+ years’ experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).

Preferred Qualifications:

Hands-on experience of protein purification, thorough understanding of chromatography and familiarization of AKTA are required

Broad understanding of downstream development and scale up including centrifugation, normal flow filtration, chromatography operations, tangential flow filtration, and virus inactivation/removal is preferred

Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities

Working knowledge of lab automation, high throughput screening, and mechanistic modeling

Demonstrated ability to collaborate and influence cross-functionally

Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire)

Excellent communication skills and strong interpersonal skills are desirable

Motivated self-starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation, and scientific writing skills

People Leader Accountabilities:

•Create Inclusion - knowing the business value of diverse teams, modeling 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, and organizational objectives, and holding

them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.