Principal Scientist, Process Development

Gilead Sciences•Foster City, CA

4d•$195,670 - $253,220•Onsite

About The Position

Principal Scientist, Purification Process Development (Pre-Pivotal) will be responsible for leading purification development including process development and process implementation at internal or external GMP facilities for Gilead biologics entities during pre-pivotal phases development (pre-clinical, phase I/II). He/she will also lead projects for purification process technology development, platform process evolution, and purification related regulatory documentation. This role is expected to work collaboratively with cross-functional stakeholders and contribute to the regulatory strategies and successful filings of Gilead’s biologics entities.

Requirements

Ph.D. in chemical engineering, bioengineering, biochemical engineering, biochemistry or related field with 5+ years or M.S. with 9+ years or B.S. with 11+ years industrial experience in biologics purification development with people leader accountabilities.
Demonstrated experience in process transfer to clinical 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 INDs.

Nice To Haves

Knowledge in single-use manufacturing technology and GMP guideline is a plus.
Working knowledge in lab automation, data science, and knowledge management is a plus.
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.
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.
Ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Team - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account.
Provide the support needed to remove barriers and connect their team to the broader ecosystem.

Responsibilities

Establish and maintain a state-of-the-art purification lab that enables rapid new biologics entity manufacturability assessment, purification process development and scaleup.
Represent department in CMC development team(s).
May lead cross functional molecule manufacturability assessment team(s).
Lead efficient purification process development.
Design laboratory scale experiments independently and oversee data generation/data integrity to ensure compliance.
Hands-on laboratory execution is expected.
Lead process transfer to internal and contract manufacturing facilities to produce GMP and non GMP drug substances on time and with high success rate.
Provide technical oversight at internal and external manufacturing facilities as person-in-plant.
Lead manufacturing atypical event investigations.
Review GMP and non-GMP technical documentation (batch records, SOPs, guidance documents, and reports).
Author/review and/or coach team members to author CMC regulatory sections of IND/INDa.
Contribute to regulatory strategies and support associated agency interactions and product-related inspections.
Hire and develop scientists.
Keep abreast of technology and innovation trends as well as best industry practices to establish a highly efficient purification team.
Mentor team members on purification process development strategies, experimental design and execution as well as process transfer.
Drive purification platform development and new technology/innovation evaluation and implementation to enable fast first-in-human clinical trial timeline.
Contribute to workflow improvements for screening lead molecules with optimal developability.
Collaborate with key stakeholder functions including Analytical Development, Cell Culture, Formulation Development, Research, Clinical Operation, and Program Strategy Teams by providing technical and strategic inputs.
Contribute to strategies and long-range plans in line with Gilead strategic priorities to deliver on Gilead’s long-term ambitions.
Participate in cross functional initiatives.
Adhere to department budget and all training, compliance and safety requirements.