Associate Scientist, Purification Process Development (Pre-Pivotal Biologics)

Posted 5 Days Ago
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Foster City, CA
110K-142K Annually
Mid level
Biotech
The Role
The Associate Scientist will execute laboratory experimentation for purification process development supporting biologics entities during pre-pivotal phases. Responsibilities include experimental design, data analysis, overseeing GMP manufacturing events, and mentoring junior staff. The role aims to establish a state-of-the-art purification lab and ensure successful process transfers and implementations in production settings.
Summary Generated by Built In

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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
 

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. The Associate Scientist, Purification Process Development (Pre-Pivotal Biologics) will execute purification process development laboratory experimentation for Gilead biologics entities during pre-pivotal phases development (pre-clinical, phase I/II). He/she will also execute laboratory experimentation for purification process technology development, platform process evolution initiatives, and will support implementation in internal and external GMP facilities.

Key Responsibilities

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

  • Contribute to experimental design. Plan and execute assigned purification process development laboratory studies. Support process scaleup and implementation in internal and external GMP facilities.

  • Collect and analyze data from laboratory experiments in compliance with data integrity policy. Author experimental protocols and reports.

  • Support process transfer to internal and contract manufacturing facilities to produce GMP and non GMP drug substances on time and with high success rate. Provide oversight at internal and external manufacturing facilities as person-in-plant. Provide technical support for manufacturing atypical event investigations.

  • Support non-GMP pilot lab operations. Review GMP and non-GMP technical documentation (batch records, SOPs, guidance documents, and reports).

  • Mentor junior team members on purification process development strategies, experimental design and execution as well as process transfer.

  • Execute purification 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 and Four Years’ Experience

OR

Masters' Degree and Two Years’ Experience

  • Degree in chemical engineering, bioengineering, biochemical engineering, biochemistry or related field with industrial experience in biologics purification development

Preferred Qualifications

  • Experience in pre-pivotal stage purification process development, scaleup and implementation in GMP and non GMP manufacturing facilities.

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

  • Demonstrated ability to collaborate and influence cross-functionally.

  • Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire).

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

  • Knowledge in single-use manufacturing technology and cGMP guideline is a plus.

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

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.

Gilead Core Values

  • Integrity (Doing What’s Right)

  • Inclusion (Encouraging Diversity)

  • Teamwork (Working Together)

  • Excellence (Being Your Best)

  • Accountability (Taking Personal Responsibility)


 

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:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.


For jobs in the United States:

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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance.
 

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

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.


For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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The Company
HQ: Foster City, CA
14,337 Employees
On-site Workplace
Year Founded: 1987

What We Do

The way we see it, the impossible is not impossible. It’s simply what hasn’t been achieved yet. For more than 30 years, we’ve pursued it, chased it down, tackled it for answers and surrounded it for a way in. We have worked tirelessly to bring forward medicines for life-threatening diseases.

Creating Possible drives everything we do. It’s evident in our mission and core values. This is how we built a culture of excellence that is fueled by a passion for improving lives of people around the world.

For us, nothing is impossible – because of the people we work with, the communities we stand with and the partners we push forward with. Our ~12,000 employees band together through science, grit, compassion and courage to prove the impossible wrong.

At Gilead, the tangible results of your contributions are evident. Where every individual matters. Where all employees can enhance their skills through ongoing development. And where we start every day with one question: “What’s next?”

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