Sr Associate Scientist, Biologics Pivotal Formulation & Process Development

Descripción del trabajo

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. We are seeking a highly motivated, attentive, and self-driven candidate to join our team, Biologics Pivotal Formulation and Process Development, as a Senior Associate Scientist. Once onboarded, the successful candidate will lead and contribute in development of formulation and drug product processes for innovative molecules to advance medicine into the clinic. The candidate will have tremendous opportunities for career growth in a fast-paced and resource-rich environment through training and professional relationships. The ideal candidate is expected to be action oriented with high expectations of themselves and others. The candidate should have great verbal and written communication and interpersonal skills.

Key Responsibilities:

• Design and execute experiments to support formulation and drug process development, including formulation screening, process development, and clinical in-use evaluations.

• Demonstrate expertise in analytical and biophysical characterization and drug product process development techniques; provide on-the-job training and guidance to new or less experienced colleagues.

• Clearly, timely, and accurately document study plans and data in lab notebooks and other repositories, following good documentation practices.

• Analyze data, draft conclusions, and discuss findings with managers or supervisors.

• Author technical documents such as memos, protocols, reports, and regulatory dossier.

• Prepare high quality and data-focused presentations for internal and external audience.

• Effectively collaborate with internal and external stakeholders in project and strategy meetings.

• Support and/or represent Biologics Pivotal Formulation and Process Development organization on cross-functional teams to advance project strategy and regulatory filings.

• Embrace a lean-agile mindset, matrix working environment, and continuous improvement.

• Support team initiatives to drive business process excellence, scientific innovation, and laboratory/work safety.

• Contribute to the completion of programs, projects, or individual business targets to ensure that company objectives are met.

Basic Qualifications:

• Bachelor's degree and 5+ years of relevant experience; OR

• Masters' degree and 3+ years of relevant experience; OR

• Hands-on laboratory experience required.

Preferred Qualifications:

• Relevant industrial experience in biologics CMC development

• Experience with formulation development, Drug Product process development, and clinical in-use evaluation for monoclonal antibodies, bispecifics, antibody-drug conjugates, fusion proteins, and other complex biologics formats strongly desired.

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.