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Cell Therapy Manufacturing Specialist

We are seeking an innovative and highly motivated Cell Therapy Manufacturing Specialist to join our Process Sciences team who will contribute significantly to the development and manufacture of our advanced cell therapy manufacturing platform. The primary focus of this position will be to support manufacturing operations, as well as day-to-day lab operations. 


Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.


Responsibilities
  • Perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.)
  • Execute manufacturing processes in both an R&D and GMP environments, following protocols and/or standard operating procedures (SOPs)
  • Provide user feedback to engineering and process teams, support with requirements gathering and review
  • Support reagent preparation, leukopak processing, and sample testing in an R&D and GMP environment
  • Contribute to analysis and presentation of technical results at departmental meetings
  • Perform routine clean room and laboratory activities including ordering, cleaning, restocking, and equipment qualification/maintenance
  • Operate in a controlled GMP environment and perform gowning as per procedure
  • Complete required training and ensure compliance with established internal and external control procedures
  • Assist in the execution of process, equipment and cleaning validation
  • Responsible for revising and originating production records, standard operating procedures, protocols and reports
  • Initiate and support the closure of Deviation Reports and CAPAs
  • Train and mentor new manufacturing associates on procedures, aseptic techniques, equipment and trouble-shooting skills
  • Review in-process and completed documents for accuracy and to make sure batch records are turned in to area management within specified days of completion
  • Work with Quality Control, Facilities, Materials Management, Quality Assurance and Validation to complete assignments
  • Other duties as assigned


Requirements
  • Bachelor’s Degree or diploma in a scientific or related field is required
  • 1+ years of experience within the biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapy
  • Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries
  • Must comply with the safety policies of the company and site
  • Adherence to cGMPs is required at all times during the manufacturing of Cell Therapy products
  • Proficiency in Drug Product-related process equipment
  • Must have experience following protocols, SOPs, and/or GMP documentation
  • Excellent verbal, written, presentation, and interpersonal skills
  • Strong analytical and problem-solving skills
  • Self-motivated and passionate about advancing the field of cell therapy
  • Self-awareness, integrity, authenticity, and a growth mindset
  • Desire to be part of a rapidly evolving organization, with compelling technology, and take products and processes to the next level


$20 - $50 an hour
Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, and Onsite lunches. All displayed pay ranges are approximate, negotiable, and location dependent.

This is Cellares


Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.

The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.


Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.


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Average salary estimate

$72800 / YEARLY (est.)
min
max
$41600K
$104000K

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 Cell Therapy Manufacturing Specialist, Cellares

Cellares is on the lookout for a highly motivated Cell Therapy Manufacturing Specialist to join our dynamic Process Sciences team at our Bridgewater, NJ facility. In this role, you will help shape the future of cell therapy manufacturing by engaging in routine lab and manufacturing operations while contributing to our cutting-edge platform. As a Cell Therapy Manufacturing Specialist, you'll be following detailed SOPs and executing manufacturing processes that adhere to both R&D and GMP standards, making your work vital to our mission. Your responsibilities will include everything from supporting reagent preparation to troubleshooting equipment issues and providing feedback to our engineering teams. In addition, you will help train and mentor new associates, ensuring they are equipped with the skills needed in this fast-paced environment. Your analytical skills will play a key role as you analyze technical results and present them in departmental meetings. At Cellares, we believe every team member's contribution matters, as we work collaboratively to bring life-saving therapies to patients globally. We're driven by innovation, and we hope you'll bring your passion for cell therapy to our rapidly evolving organization. Cellares offers a competitive compensation package along with excellent benefits, including subsidized healthcare plans and retirement matching. Come join a team that is truly revolutionizing cell therapy manufacturing and making a real difference in the world!

Frequently Asked Questions (FAQs) for Cell Therapy Manufacturing Specialist Role at Cellares
What are the primary responsibilities of a Cell Therapy Manufacturing Specialist at Cellares?

As a Cell Therapy Manufacturing Specialist at Cellares, your primary responsibilities will involve executing and supporting cell therapy manufacturing processes in both R&D and GMP environments. You'll follow SOPs, prepare reagents, process leukopak, conduct sample testing, and assist in the maintenance of laboratory equipment. Your role also includes contributing to the analysis of technical results and mentoring new associates, ensuring that everyone adheres to the highest safety and quality standards.

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What qualifications are required for the Cell Therapy Manufacturing Specialist role at Cellares?

To qualify for the Cell Therapy Manufacturing Specialist position at Cellares, candidates must possess a Bachelor’s Degree or diploma in a scientific or related field, along with at least 1 year of work experience in cGMP Operations within the biotech or biopharma industry. Knowledge of safety procedures, adherence to cGMP guidelines, and the ability to follow protocols and SOPs are crucial for success in this role.

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Can you describe the work environment for the Cell Therapy Manufacturing Specialist at Cellares?

The work environment for a Cell Therapy Manufacturing Specialist at Cellares is fast-paced and mission-driven, designed to foster innovation and collaboration. Team members will operate in controlled GMP settings, adhering to strict protocols. It's essential for candidates to thrive in dynamic situations and be prepared to tackle various challenges as we work towards advancing cell therapy technologies.

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What skills are essential for the Cell Therapy Manufacturing Specialist position at Cellares?

Key skills for the Cell Therapy Manufacturing Specialist role at Cellares include strong analytical and problem-solving abilities, excellent verbal and written communication skills, and a self-motivated attitude. Candidates should be passionate about cell therapy, exhibit integrity and authenticity, and have a growth mindset, as you'll be part of a rapidly evolving organization committed to innovation in cell therapy manufacturing.

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What growth opportunities exist for a Cell Therapy Manufacturing Specialist at Cellares?

At Cellares, growth opportunities for a Cell Therapy Manufacturing Specialist are abundant. As the company continues to advance in the biotech field, employees are encouraged to develop their skills further, take on mentorship roles, and contribute to training programs. Additionally, the dynamic nature of our work offers numerous chances to lead projects, engage in cutting-edge technologies, and be at the forefront of the cell therapy manufacturing industry.

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Common Interview Questions for Cell Therapy Manufacturing Specialist
Can you describe your experience with cGMP operations in the biotech industry?

When answering this question, highlight specific instances where you have worked within cGMP regulations. Discuss your familiarity with protocols and SOPs and how you've contributed to maintaining compliance in your previous roles.

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What techniques do you use for troubleshooting equipment in a manufacturing environment?

Discuss systematic approaches you employ to identify and resolve issues, including using process documentation, collaborating with team members, and drawing on your knowledge from previous hands-on experiences in lab and manufacturing setups.

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How do you ensure accuracy in batch records and documentation?

Explain your meticulous attention to detail when completing batch records. Share strategies you use for double-checking your work and adhering to established documentation practices to maintain compliance and ensure product quality.

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What is your approach to training new team members?

Describe your commitment to fostering a supportive learning environment. Mention how you customize training sessions to fit individual learning styles, focusing on hands-on demonstrations and following SOPs to ensure thorough understanding.

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Can you explain how you handle tight deadlines in fast-paced environments?

Share examples of how you prioritize tasks and manage time effectively to meet deadlines. Highlight your organizational skills and your ability to remain composed and focused under pressure while maintaining high-quality work standards.

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What motivates you to work in the field of cell therapy?

Reflect on your personal or professional inspirations for pursuing a career in cell therapy. Emphasize how the impact of cell therapies on patient lives drives your passion for contributing to advancements in the industry.

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How do you stay updated on industry trends and advancements in cell therapy?

Discuss your commitment to continuous learning by following industry publications, participating in webinars, attending conferences, and engaging with professional networks. This shows your initiative and enthusiasm for being at the forefront of cell therapy innovation.

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How do you approach safety in the lab environment?

Demonstrate your understanding of safety protocols by giving examples of how you promote safety in the workplace. Mention the importance of compliance with health and safety training and how you proactively address potential hazards.

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How do you contribute to teamwork and collaboration in a lab setting?

Provide examples of your collaborative experiences, showcasing how you’ve effectively communicated with colleagues and contributed to team projects. Emphasize your adaptability and willingness to support team efforts to achieve common goals.

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What role do you see a Cell Therapy Manufacturing Specialist playing in reaching the company goals at Cellares?

Illustrate your understanding of the role's significance by connecting your responsibilities with Cellares' mission to advance cell therapy manufacturing. Discuss how your contributions can impact patient outcomes and help drive our technology forward.

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DATE POSTED
April 16, 2025

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