Principal Scientist, Analytical Ops

Kite Pharma; Santa Monica (CA); On-site; USD 177,000 - 231,000; Full time

Job summary

An innovative biopharmaceutical company is seeking a Principal Scientist in Analytical Operations to drive advancements in cancer therapies. This role involves leading analytical strategies, collaborating with cross-functional teams, and ensuring regulatory compliance for cutting-edge therapies. The ideal candidate will possess extensive experience in CMC analytical control and thrive in a dynamic environment. Join a team dedicated to curing cancer and make a significant impact in the field of immunotherapy. If you are passionate about science and innovation, this is the opportunity for you.

Benefits

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Medical insurance

Dental insurance

Vision insurance

Life insurance

Qualifications

• PhD with 5+ years in CMC analytical control strategy.
• Master's with 8+ years or Bachelor's with 10+ years in industry.

Responsibilities

• Lead implementation of analytical control strategy.
• Oversee analytical readiness for IND/BLA filings.
• Define project decisions and risks.

Skills

Project management

Analytical techniques

Interpersonal skills

Problem-solving

Critical thinking

Education

PhD in related field

Master's Degree in related field

Bachelor's Degree in related field

Tools

Project management tools

Job description

Join to apply for the Principal Scientist, Analytical Ops role at Kite Pharma

Join to apply for the Principal Scientist, Analytical Ops role at Kite Pharma

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.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 [e-mail] 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 Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

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