Associate Scientist, Purification Process Development – Pivotal & Commercial Biologics

Gilead Sciences, Inc.; Foster City (CA); On-site; USD 109,000 - 142,000; Full time

Job summary

An established industry player is seeking a passionate Associate Scientist to lead purification process development for pivotal and commercial biologics. This role involves executing laboratory studies, supporting technology transfers, and mentoring junior team members. You'll contribute to the development of life-changing therapies in a collaborative environment. With a focus on innovation, you'll help establish a state-of-the-art purification lab while adhering to compliance and safety standards. Join a team that values diversity and is committed to making a difference in global health.

Benefits

Discretionary Annual Bonus

Stock-Based Long-Term Incentives

Paid Time Off

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Qualifications

• 2+ years of experience in purification process development.
• Hands-on experience with chromatography and filtration operations.

Responsibilities

• Lead and execute purification process development and characterization.
• Support technology transfers and ensure high-quality documentation.

Skills

Laboratory Operations

Purification Process Development

Data Analysis

Collaboration Skills

Communication Skills

Education

M.S. in relevant scientific discipline

B.S. in relevant scientific discipline

Tools

AKTA Chromatography Systems

UNICORN Software

JMP

Spotfire

Job description

Associate Scientist, Purification Process Development – Pivotal & Commercial Biologics

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

The Associate Scientist, Purification Process Development (Pivotal and Commercial) will be responsible for leading and executing aspects of purification development including process development and process characterization at internal or external facilities for Gilead biologics entities during pivotal and commercial development phases. He/she will also lead and execute projects for purification process technology development and platform process evolution.

Key Responsibilities:

1. Contribute to experimental design. Plan and execute assigned purification process development laboratory studies. Support process scaleup and implementation in internal and external GMP facilities.
2. Collect and analyze data from laboratory experiments in compliance with data integrity policy. Author experimental protocols and reports.
3. Support process transfer to internal and contract manufacturing facilities to produce GMP and non GMP drug substances on time and with high success rate.
4. Travel as required to support technology transfers and provide oversight at external manufacturing facilities.
5. Provide technical support for manufacturing atypical event investigations.
6. Ensure high-quality documentation in electronic laboratory notebooks, protocols and reports.
7. Mentor junior team members on purification process development strategies, experimental design and execution as well as process transfer.
8. Help to establish and maintain a state-of-the-art purification lab.
9. Execute purification platform development and new technology/innovation evaluation and implementation to enable pivotal clinical trials.
10. Participate in cross functional initiatives as needed.
11. Adhere to department budget and all training, compliance and safety requirements.

Qualifications/Skills/Experience:

1. M.S. with 2+ years or BS with 4+ years’ experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).

Preferred Qualifications:

1. Hands-on laboratory operations experience with purification process operations including centrifugation, normal flow filtration, high throughput purification screening and development, chromatography operations, tangential flow filtration, and virus inactivation/removal is required.
2. Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities.
3. Experience with AKTA chromatography systems and UNICORN software is preferred.
4. Working knowledge of lab automation, data management, data science, knowledge management and data protection.
5. Demonstrated ability to collaborate and influence cross-functionally.
6. Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire).
7. Motivated self-starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation, and scientific writing skills.

The salary range for this position is: $109,650.00 - $141,900.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

For additional benefits information, visit: Gilead Benefits

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.