Principal Scientist, Analytical Ops

Gilead Sciences, Inc.; Santa Monica (CA); On-site; USD 177,000 - 231,000; Full time

Job summary

Join a pioneering biopharmaceutical company dedicated to curing cancer as a Principal Scientist in Analytical Operations. This role involves leading the analytical control strategy for advanced therapy medicinal products, collaborating with cross-functional teams, and ensuring regulatory readiness. The ideal candidate will possess a strong background in CMC analytical strategies and method lifecycle management. Be part of a mission-driven organization that values leadership and innovation, where your contributions will directly impact the future of cancer therapies. Embrace the challenge and help create more tomorrows for patients in need.

Benefits

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Company-sponsored medical insurance

Dental insurance

Vision insurance

Life insurance plans

Qualifications

• PhD with 5+ years or Master’s with 8+ years of industry experience required.
• In-depth experience in CMCs/cGMPs for advanced therapy medicinal products preferred.

Responsibilities

• Lead implementation of analytical control strategy and ensure analytical readiness.
• Oversee analytical sub-team and collaborate with cross-functional groups.

Skills

CMC analytical control strategy

method lifecycle management

project management

analytical techniques

interpersonal communication

problem-solving

Education

PhD in relevant field

Master’s Degree

Bachelor’s Degree

Tools

project management tools

Job description

Principal Scientist, Analytical Ops

United States - California - Santa Monica Process/Product Development & Operations Regular

Job Description

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

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 Kite and help create more tomorrows.

Job Description

We are seeking a highly motivated individual with a background in CMC analytical control strategy and method lifecycle management experience of Advanced therapy medicinal products to join us as a Principle Scientist, Analytical Operations, at our Santa Monica, California location. The individual will be an Analytical Sub-team Lead (ASTL) in Analytical Development who will work within cross functional groups with process development, quality, regulatory to lead the implementation of the analytical control strategy through the lifecycle of a program.

Responsibilities include (but are not limited to):

Lead the overall implementation of the analytical control strategy

Enable Analytical readiness for success of IND/BLA filings

Serves as an analytical team Representative in Cross-functional forum

Lead a core Analytical Sub-team within analytical to oversee the Analytical Control Strategy of program(s)

Create analytical roadmaps and timelines with trackable key milestones that clearly reflect the CMC strategy

Define and track project decisions, risks, action items, sampling plan, etc.

Lead the efforts of method deployment to Quality Control. Strategic partner with Quality Control, representing Analytical function in Product Quality Team

Strategic partner with Process Development representing Analytical in Product Development Team

Provide regulatory filing support as needed as an Analytical Representative

Collect feedback from Analytical sub-teams to continue improving business processes

Besides being a strategic lead, the ASTL is accountable for many operational deliverables, like own program specific meetings, Analytical program risk register, oversee sampling plan from method development and phase-appropriate validation, etc.

Basic Qualifications:

PhD and 5+ years of related industry

OR

Master’s Degree and 8+ years of related industry experience

OR

Bachelor’s Degree and 10+ years of related industry experience

Preferred Qualifications:

In-depth experience of CMCs/cGMPs for Advanced therapy medicinal products (Cell Therapy and viral vectors for gene therapy)

Understand ICH guidelines and other regulatory guidelines and requirements

Basic knowledge in analytical techniques such as Flow cytometry, ddPCR, Potency and compendial methods techniques

Project management experience and proficient in project management tools

Excellent interpersonal, verbal, and written communication skills

Ability to lead a cross-functional, diverse, experienced strategic and technical staff

Ability to influence and lead without authority, influencing others and achieving desired outcomes through persuasion, collaboration, and building trust

Ability to think critically and demonstrate troubleshooting and problem-solving skills, and work with and lead others

Ability to function efficiently and independently in a changing environment

Work independently. Comfortable in a fast-paced environment with minimal direction and able to adjust workload based on changing priorities

Self-motivated, detail-oriented, excellent interpersonal skills, and willing to accept temporary responsibilities outside of initial job description

Job Description

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

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 Kite and help create more tomorrows.

Job Description

We are seeking a highly motivated individual with a background in CMC analytical control strategy and method lifecycle management experience of Advanced therapy medicinal products to join us as a Principle Scientist, Analytical Operations, at our Santa Monica, California location. The individual will be an Analytical Sub-team Lead (ASTL) in Analytical Development who will work within cross functional groups with process development, quality, regulatory to lead the implementation of the analytical control strategy through the lifecycle of a program.

Responsibilities include (but are not limited to):

• Lead the overall implementation of the analytical control strategy

• Enable Analytical readiness for success of IND/BLA filings

• Serves as an analytical team Representative in Cross-functional forum

• Lead a core Analytical Sub-team within analytical to oversee the Analytical Control Strategy of program(s)

• Create analytical roadmaps and timelines with trackable key milestones that clearly reflect the CMC strategy

• Define and track project decisions, risks, action items, sampling plan, etc.

• Lead the efforts of method deployment to Quality Control. Strategic partner with Quality Control, representing Analytical function in Product Quality Team

• Strategic partner with Process Development representing Analytical in Product Development Team

• Provide regulatory filing support as needed as an Analytical Representative

• Collect feedback from Analytical sub-teams to continue improving business processes

• Besides being a strategic lead, the ASTL is accountable for many operational deliverables, like own program specific meetings, Analytical program risk register, oversee sampling plan from method development and phase-appropriate validation, etc.

Basic Qualifications:

• PhD and 5+ years of related industry

OR

• Master’s Degree and 8+ years of related industry experience

OR

• Bachelor’s Degree and 10+ years of related industry experience

Preferred Qualifications:

• In-depth experience of CMCs/cGMPs for Advanced therapy medicinal products (Cell Therapy and viral vectors for gene therapy)

• Understand ICH guidelines and other regulatory guidelines and requirements

• Basic knowledge in analytical techniques such as Flow cytometry, ddPCR, Potency and compendial methods techniques

• Project management experience and proficient in project management tools

• Excellent interpersonal, verbal, and written communication skills

• Ability to lead a cross-functional, diverse, experienced strategic and technical staff

• Ability to influence and lead without authority, influencing others and achieving desired outcomes through persuasion, collaboration, and building trust

• Ability to think critically and demonstrate troubleshooting and problem-solving skills, and work with and lead others

• Ability to function efficiently and independently in a changing environment

• Work independently. Comfortable in a fast-paced environment with minimal direction and able to adjust workload based on changing priorities

• Self-motivated, detail-oriented, excellent interpersonal skills, and willing to accept temporary responsibilities outside of initial job description

The salary range for this position is: $177,905.00 - $230,230.00. Kite 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.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com . Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma .

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Job Requisition ID R0045082

Full Time/Part Time Full-Time

Job Level Associate Director

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