Principal Scientist, Quality Control Biologics (Microbiology)

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.

Microbiology:

The QC Microbiology Principal Scientist is vital role for the success of Clinical and Commercial Biologics and Small Molecule Quality Control. This individual provides support for strategic leadership and oversight of daily microbiological operations. Responsibilities include managing clinical and commercial microbiological specification strategies (for product, raw materials and critical reagents programs), analytical method validations, and the compendial review program.

The role will contribute to monitoring QC test method execution and leading the microbiological lifecycle management of clinical/commercial small molecules/biologics API/drug substances and drug products.

Department:

Global Quality Control – GQC-Biologics and Small Molecules

Job Responsibilities:

• Experience with Biologics and/or Small Molecules Quality Control microbiology and 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.

Qualifications:

• 10+ Years experience with BS OR

• 8+ Years with MS OR

• 5+ years of experience and PhD in Microbiology, Chemistry, Biochemistry or related field.

• 2+ years of relevant experience in a GMP Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring.

• Deep knowledge and experience in Biopharmaceutical or Pharmaceutical quality control. Stays ahead of shifting microbiological trends in industry.

• 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.