Principal Scientist, Quality Control Biologics (Analytical Lifecycle Management)

职位描述

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Analytical Lifecycle Management:

The Principal Scientist, Analytical Lifecycle Management is vital for the success of Clinical Biologics QC, providing support for strategic leadership and oversight of daily operations. Responsibilities include managing Clinical specification strategies, reference standards, raw materials, and critical reagents programs, analytical method validations and transfers, and the compendial review program. The role will contribute to monitoring QC test method execution and leading the analytical lifecycle management of Clinical biologics drug substances and drug products.

Department:

Global Quality Control – GQC-Biologics

Job Responsibilities:

• Experience over a broad set of Quality Control sub-functions with extensive knowledge of industry best practices and trends.

• In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.

• Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.

• Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness.

• Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist.

• Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions.

• Demonstrated an ability to develop a vision for Quality Control functions and have shaped the capabilities of the function to fulfill that vision.

• Demonstrated the ability to influence process and outcomes across functions.

• Willing to support future laboratory work.

• Willing to support Commercial QC team.

Qualifications:

• 10+ Years experience with BS OR

• 8+ Years with MS OR

• 5+ Years with PhD in Chemistry, Biochemistry or related field.

• 2+ year of relevant experience in a GMP Lab environment, including knowledge of analytical testing, familiarity with laboratory instrumentation.

• Preferred experience in Biopharmaceutical or Pharmaceutical quality control. Stays ahead of shifting trends in industry and GMP systems/software (e.g. LIMS, QMS, Empower).

• Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.

• Strong organizational and planning skills.

• Shows excellent verbal and written communication skills and collaborative interpersonal skills.