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Principal QC Specialist

Who We Are

Arcellx is a public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to destroy cancer and advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible.

Our team members are made up of talented innovators and dreamers working from our offices in Rockville, Maryland, and Redwood City, California. At Arcellx, we hire exceptional people and create a fun, diverse, supportive, and informal environment that allows everyone to do their best work.

What Matters to Us

Living our core values is essential to maintaining a work environment that is high-performing, inclusive, and collaborative. We look for candidates who demonstrate strong values alignment and bring different backgrounds, viewpoints, and abilities to the team.

Arcellx Core Values

  • Character: Committed to always doing what’s right.
  • Audacity: Willing to challenge convention and share candid feedback with others.
  • Determination: Curious and self-motivated. Always looking to improve and learn.  
  • Collaboration: "No job is too small" mentality. Humble and willing to help others.
  • Originality: Will bring your unique perspective to the table and respect a diverse set of views and backgrounds.

How You’ll Make a Difference

As a Principal QC Specialist in our Quality Control group in Redwood City, you will have a direct impact on the Arcellx drug pipeline, both as a thought leader and a lab-based contributor. Our potentially life-saving treatments would not exist without the work of our talented scientists  and specialists. Your work will have a direct impact on our ability to deliver our transformative therapy to patients who need it most.

The “Fine Print” – What You’ll Do

  • Collaborate with teammates to develop and build our new QC testing laboratory from the ground up.
  • Establish sample management and chain of custody program, laboratory management system, and data backup system.
  • Perform technical review of GMP method qualification, method transfer, analytical testing associated with the batch release, stability and product characterization.
  • Draft and develop QC related SOPs, protocols, reports, impact assessments and root cause analysis.
  • Be a subject Matter Expert (SME) for the QC assays, especially molecular based assays.
  • Lead and approve for QC GMP Quality Management Systems, including Lab Investigation, OOS/OOTs, deviations, CAPAs and change controls.
  • Coordinate activities to establish equipment/instrument qualification and validation program to meet the quality standards.

What We Look For

  • Bachelor’s degree in relevant field (e.g. immunology, cellular biology and molecular biology). Advanced degree preferred.
  • Minimum of 12 years (with BS), 10 years (with MS), or 7 years (with PhD) of experience in Quality Control or related areas within the biotech or pharma companies.  
  • Expertise in molecular-based assays.
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines.
  • Strong collaboration, communication, and interpersonal skills. Demonstrated ability to influence within a matrix team structure.
  • Strong knowledge of cGMP/ICH/FDA regulations.

Rewards at Arcellx

Our people are our greatest asset, and supporting their well-being is an essential part of delivering on our mission and impacting the lives of patients. Putting this belief into practice means offering strong compensation and benefits.

The base salary range for this position is $140,000 - $170,000 per year. Where a candidate falls within that range is determined by factors such as years of experience. Our compensation package also includes an annual bonus based on company goals and an equity (RSU) grant. We do offer relocation assistance for roles if required.

Our market-leading benefits package includes: 100% coverage for medical, dental and vision for team members and dependents, unlimited vacation, a 3-day weekend every month, fully-paid parental leave for up to 6 months, tuition reimbursement, 401k employer contribution and more. 

Join us in our quest to reimagine cell therapy and destroy cancer. For more on our technology, culture, and team, go to www.arcellx.com.

 #LI-Onsite

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Average salary estimate

$155000 / YEARLY (est.)
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$140000K
$170000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Principal QC Specialist, Arcellx

At Arcellx, we're not just another biotech company; we're a pioneering force in the realm of cell therapy, aiming to revolutionize treatments for cancer and other grievous ailments. We’re currently searching for a Principal QC Specialist to join our vibrant team in Redwood City, CA. In this fulfilling role, you won't merely contribute; you'll be a pivotal player in developing our quality control testing laboratory from the ground up. Your expertise in molecular-based assays will truly shine as you lead technical reviews, establish our sample management systems, and support the complex processes that bring life-saving treatments to patients. Imagine drafting SOPs, building a collaborative environment, and influencing a talented team focused on excellence. With your strong background in Quality Control in the biotech industry and your passion for innovation, you'll help us navigate the challenges of the drug pipeline. Plus, we deeply value the unique perspectives every team member brings to the table, fostering a culture where everyone can thrive. This isn’t just about filling a position; it’s about joining a mission-driven team that values character, audacity, determination, collaboration, and originality. If you're ready to take your career to the next level and make a real difference, we invite you to explore this opportunity at Arcellx.

Frequently Asked Questions (FAQs) for Principal QC Specialist Role at Arcellx
What does a Principal QC Specialist do at Arcellx?

A Principal QC Specialist at Arcellx plays a critical role in ensuring the quality of our life-saving therapies. This position involves collaborating on the establishment of our QC testing laboratory, performing technical reviews, and leading quality management systems. Your expertise in molecular-based assays is vital in maintaining compliance with cGMP standards and ensuring our drug pipeline meets rigorous quality demands.

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What qualifications are required for the Principal QC Specialist position at Arcellx?

To apply for the Principal QC Specialist role at Arcellx, candidates typically need a bachelor's degree in fields such as immunology or molecular biology. Advanced degrees are preferred, along with a minimum of 7 to 12 years of experience in Quality Control or related fields. Proficiency in molecular-based assays and a solid understanding of cGMP/ICH/FDA regulations are also crucial for being successful in this role.

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How can the Principal QC Specialist impact Arcellx's mission?

As a Principal QC Specialist at Arcellx, you will have a direct, tangible impact on our mission to reimagine cell therapy. Your work ensures that we uphold the highest quality standards, enabling these innovative therapies to reach patients who desperately need them. This role is at the heart of delivering safe and effective treatments to combat cancer and improve patient lives.

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What does the work environment look like for a Principal QC Specialist at Arcellx?

At Arcellx, the work environment is dynamic and collaborative, emphasizing diversity and inclusion. As a Principal QC Specialist, you will engage closely with a team of innovators, experiencing a culture that encourages brainstorming, open feedback, and a sense of belonging. The informal yet high-performing atmosphere allows professionals to thrive and contribute uniquely to our collective goals.

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What kind of salary and benefits can a Principal QC Specialist expect at Arcellx?

The base salary for a Principal QC Specialist at Arcellx ranges from $140,000 to $170,000 per year, depending on experience. Along with a competitive salary, we offer an attractive benefits package, including 100% coverage for medical, dental, and vision insurance, unlimited vacation days, a 3-day weekend every month, and fully-paid parental leave up to 6 months. Additional perks like tuition reimbursement and 401k contributions enhance the overall employment experience.

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What are the core values of Arcellx and how do they influence the Principal QC Specialist role?

Arcellx is driven by core values such as character, audacity, determination, collaboration, and originality. These values influence the Principal QC Specialist role by fostering an environment where ethical decisions are paramount, innovative ideas are encouraged, and teamwork is fundamental. Your alignment with these values will be critical for thriving within our team and driving our mission forward.

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What are the career growth opportunities for a Principal QC Specialist at Arcellx?

In the role of Principal QC Specialist at Arcellx, there are numerous career growth opportunities. With our focus on professional development, you can expand your skills in Quality Control, engage in leadership roles, or transition into higher operational or scientific positions within the company. Arcellx values continuous learning, and as the company grows, so too do the pathways for each team member's career.

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Common Interview Questions for Principal QC Specialist
Can you describe your experience with QC processes in biotechnology?

When answering this question, share specific examples of your previous roles, focusing on projects where you were responsible for quality control measures. Highlight your expertise in molecular-based assays and detail how you ensured compliance with regulatory standards.

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How do you prioritize tasks when managing multiple QC projects?

To effectively respond, discuss your organizational methods, such as using project management tools or prioritizing based on project timelines and impact. Share an example illustrating how you successfully managed competing priorities in past roles.

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What is your approach to root cause analysis?

In your answer, outline the steps you take during a root cause analysis, such as data collection, identifying potential causes, and proposing solutions. Providing a real-life scenario where you successfully implemented these steps can add weight to your response.

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Explain your experience with GMP regulations.

Discuss your familiarity with Good Manufacturing Practices and how you have adhered to or implemented these regulations in past positions. Emphasize the importance of compliance and how it affects product quality and safety.

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What techniques do you use for method validation?

Here, detail the specific methods you've employed for validating QC techniques that you’ve worked with. Mention any experiences with analytical testing or method development that demonstrate your expertise.

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Can you describe a challenging project and how you contributed?

When asked this question, consider sharing a project where you faced significant challenges. Focus on your role, the strategies you implemented to overcome obstacles, and the positive outcomes that resulted from your contributions.

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How do you work collaboratively with other teams within a biotech environment?

Emphasize the importance of collaboration by providing examples of interdepartmental projects you have worked on. Illustrate how effective communication and teamwork contributed to the success of those projects.

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What motivates you as a Principal QC Specialist?

Reflect on your personal motivations that drive you in this role. It might include a commitment to patient outcomes, the satisfaction of innovation in cell therapies, or the desire to uphold quality standards. Expressing genuine passion can resonate well with interviewers.

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How do you stay current with advancements in biotechnology and QC practices?

Discuss your strategies for staying updated, such as attending industry conferences, participating in relevant training, or reading scientific literature. This shows your commitment to continuous improvement, which aligns with Arcellx's values.

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What role does data analysis play in your quality control work?

Explain how you utilize data analysis in the QC process, whether it's for performance monitoring, trend analysis, or compliance tracking. Provide examples of tools or methods you use to extract meaningful insights from data.

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Advance humanity by engineering cell therapies that are safer, more effective, and more broadly accessible.

6 jobs
MATCH
VIEW MATCH
FUNDING
SENIORITY LEVEL REQUIREMENT
TEAM SIZE
SALARY RANGE
$140,000/yr - $170,000/yr
EMPLOYMENT TYPE
Full-time, on-site
DATE POSTED
November 27, 2024

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