Senior Scientist, Quality Control- Microbiology (Small Molecule)

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

QC Microbiology:

The QC Microbiology Senior 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. The role will contribute to monitoring QC test method execution and the microbiological lifecycle management.

The role is accountable for refining QC procedures across Gilead’s small molecule and biologics manufacturing network, ensuring global cGMP compliance. Responsibilities also include managing clinical and commercial microbiological sample shipping and testing logistics and data entry from CTLs/CMOs into Gilead’s LIMS.

Department:

Global Quality Control – GQC-Biologics and Small Molecules

Job Responsibilities:

• Experience with 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.

Basic Qualifications:

• PhD in Microbiology, Chemistry, Biochemistry or related field with 2+ years of relevant experience in a 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 OR

• MS in Microbiology, Chemistry, Biochemistry or related field with 6+ years of relevant experience in a 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 OR

• BS in Microbiology, Chemistry, Biochemistry or related field with 8+ years of relevant experience in a 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 OR

• Associate’s degree in Microbiology, Chemistry, Biochemistry or related field with 10+ years of relevant experience in a 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 OR

• HS degree with 12+ years of relevant experience in a 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.

Preferred Qualifications:

• Preferred 2+ years of relevant experience in a 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.

• Knowledge and experience in Small Molecule Oral Solid Dose and Sterile Small Molecule manufacturing.

• 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.

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.