Principal Scientist, Analytical Ops

Principal Scientist, Analytical OpsUnited States - California - Foster City Clinical Development & Clinical Operations Regular

All candidates should make sure to read the following job description and information carefully before applying.

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses

worldwide.

The Principal Scientist in Biologics Analytical Development (Pivotal and Commercial) will be responsible for leading analytical development activities encompassing analytical project leadership and development of analytical methods. Additionally, they will be for responsible for ensuring that product quality targets and specifications are established for the projects they lead based on robust patient-centric 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

o Mentor and guide scientists in their roles

o Set clear expectations and prioritization of work packages

o Manage workload and resources effectively

o Developing analytical control strategies for drug substance and drug product, ensuring patient-centric considerations are incorporated

o Development of robust analytical methods for drug substance and drug product appropriate for pivotal and commercial programs.

o Design and execution of scientifically sound and regulatory compliant method bridging strategies

o Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies

o 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

o Exhibit comprehensive knowledge of cGMP practices and requirements

o Act as a key member of the extended Analytical Development leadership team to shape late-stage development strategies

o Demonstrate comprehensive knowledge in key analytical CMC strategic areas including CQAs, separations methods, method bridging, reference standard, comparability, and specifications

o Drive for the adoption of novel and state-of-the-art analytical technologies and approaches

o Mange and mentor talent to help cultivate a world class Biologics AD organization

Basic Qualifications :

Bachelor's Degree and Ten Years' Experience

OR

Masters' Degree and Eight Years' Experience

OR

PhD and Five Years' Experience

Preferred Qualifications :

People Leader Accountabilities :

way they manage their teams.

performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and

realize their purpose.

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

Share :

Job Requisition ID R0045350

Full Time / Part Time Full-Time

Job Level Associate Director

Click below to return to the Gilead Careers site

Click below to see a list of upcoming events

Click below to return to the Kite, a Gilead company Careers site

#J-18808-Ljbffr