Scientist, Biologics Pilot Lab- Pre-Pivotal Biologics Development

仕事内容

The Scientist, Biologics Pilot Lab will plan and execute pilot scale purification operations to generate materials to support toxicology studies as well as Research and Process Development activities. (S)he will be responsible for Pilot Lab operation readiness, staff training, innovation, and technology evaluation in collaboration with process development groups to improve Pilot Lab operation capacity, efficiency and process productivity. This role is expected to work collaboratively with cross-functional stakeholders and contribute to the successful filings of Gilead’s biologics entities.

Key Responsibilities:

• Maintain a state-of-the-art purification lab that enables rapid new biologics entities manufacturability assessment, purification process development and scaleup.

• Contribute to material generation planning. Execute pilot scale purification operations. Support process scaleup and implementation in the Pilot Lab.

• Collect and analyze data from Pilot Lab runs in compliance with data integrity policy. Author and review batch records, protocols and reports.

• Transfer process to the Pilot Lab timely and with high success rate. Provide technical support for Pilot run atypical event investigations.

• Author and maintain Pilot Lab work instructions, standard operating procedures and training plans. Provide training to Pilot Lab operators.

• Mentor junior team members on Pilot Lab operation, batch record authoring, operation planning and execution as well as process transfer.

• Contribute to biologics manufacturing platform development and new technology/innovation evaluation and implementation to enable fast first-in-human clinical trial timeline.

• Participate in cross functional initiatives as needed.

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

Basic Qualifications:

Bachelor’s Degree with 6 years’ experience

OR

Master’s Degree with 4 years’ experience

OR

PhD/ PharmD

Preferred Qualifications:

• M.S. in Chemical Engineering, Bio-engineering, Biochemical Engineering, Biochemistry or related field with 4+ years (or B.S. with 6+ years) of industrial experience in biologics purification development and/or scaleup operations.

• Hands-on experience on pilot scale purification operation planning and execution. Experience in tech transfer process scale-up.

• Working knowledge in single-use manufacturing technology.

• Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving.

• Demonstrated ability to collaborate and influence cross-functionally.

• Experience in data analysis (e.g. JMP, Spotfire), creating and maintaining batch records, authoring operation procedures and reports.

• Working knowledge of lab automation, data management, data science, knowledge management and data protection is a plus.

• Passion for inclusion: knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way he/she works.

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.