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Upstream Manufacturing Scientist

Upstream Manufacturing Scientist

To support our next growth phase, we are hiring seven Upstream Manufacturing Scientists at various experience levels to meet the increasing demands of our Upstream and Downstream Manufacturing teams. These teams are gearing up to scale from pilot manufacturing to full-scale commercial production at our new NJ facility.

Positions Available:

  • Manufacturing Scientist I - 3 - from 1 years of experience +

USP Manufacturing Scientists:

  • Execute mammalian cell culture processes to produce recombinant proteins for biologics, managing cell culture batches up to 2000L.
  • Operate bioreactors, establish equipment specifications, and enhance manufacturing techniques.
  • Collaborate with manufacturing associates and engineers, providing clear instructions and guidance.
  • Initiate batch records, protocols, and oversee investigations in a cGMP environment to ensure compliance.
  • Review and document manufacturing and packaging batch records, ensuring adherence to safety standards and GMP guidelines.

Experience/Qualifications:

Upstream:

  • At least 1-2 years of experience in cell culture and bioreactor operations, including GMP and aseptic manufacturing experience.
  • Proficiency with single-use manufacturing consumables (e.g., bags, tube sets, columns) and experience in scale-up manufacturing activities.

Average salary estimate

$80000 / YEARLY (est.)
min
max
$70000K
$90000K

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 Upstream Manufacturing Scientist, Pharma Universe

If you're passionate about biomanufacturing and have a knack for cell culture processes, then the Upstream Manufacturing Scientist position at our innovative company is the perfect opportunity for you! As we expand our operations and gear up for full-scale production at our brand-new facility in New Jersey, we are looking to add seven talented individuals to our Upstream Manufacturing team. This role, available across various experience levels, will involve executing mammalian cell culture processes to produce high-quality recombinant proteins for biologics. You'll be managing cell culture batches up to 2000L and operating advanced bioreactors. Your collaboration with manufacturing associates and engineers will be key, as you'll provide clear instructions and guidance that drive our success. Ensuring compliance within a cGMP environment will also be a critical part of your role, where you'll initiate batch records and protocols while overseeing investigations as needed. With a focus on safety and GMP guidelines, your attention to detail will shine as you review and document manufacturing and packaging batch records. Ideal candidates will have at least 1-2 years of relevant experience in cell culture and bioreactor operations, with a solid understanding of GMP and aseptic manufacturing practices. Proficiency with single-use manufacturing consumables is a must as well. Come join us and be a part of our exciting growth journey as an Upstream Manufacturing Scientist!

Frequently Asked Questions (FAQs) for Upstream Manufacturing Scientist Role at Pharma Universe
What are the main responsibilities of an Upstream Manufacturing Scientist at your company?

The Upstream Manufacturing Scientist at our company is responsible for executing mammalian cell culture processes to produce recombinant proteins for biologics, operating bioreactors, and enhancing manufacturing techniques. You will manage cell culture batches up to 2000L, collaborate with associates and engineers, and ensure compliance with cGMP regulations by reviewing batch records.

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What qualifications are required for the Upstream Manufacturing Scientist position?

To qualify for the Upstream Manufacturing Scientist position at our company, candidates should have at least 1-2 years of experience in cell culture and bioreactor operations, familiarity with GMP and aseptic manufacturing processes, and proficiency with single-use manufacturing consumables. This background will enable you to excel in our innovative biomanufacturing environment.

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What does the training process look like for new Upstream Manufacturing Scientists?

New Upstream Manufacturing Scientists at our company will undergo a comprehensive training process that includes mentorship from experienced team members, exposure to our biomanufacturing processes, and hands-on experience in our state-of-the-art facility. This training ensures that you are well-prepared to execute your responsibilities effectively.

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What types of bioreactors will I be working with as an Upstream Manufacturing Scientist?

As an Upstream Manufacturing Scientist at our company, you will work with a variety of bioreactors designed for large-scale cell culture. This includes both traditional and single-use technologies, allowing you to optimize and innovate our processes to increase efficiency and output.

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What are the growth opportunities for an Upstream Manufacturing Scientist in your company?

Our company is committed to fostering growth and development for our Upstream Manufacturing Scientists. With our expansion plans and ongoing training programs, you will have opportunities for career advancement, including positions in leadership, project management, or specialized scientific roles as you gain experience and expertise.

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Common Interview Questions for Upstream Manufacturing Scientist
Can you explain your experience with mammalian cell culture processes?

In your response, highlight specific experiences where you executed mammalian cell culture processes, the types of cell lines you’ve worked with, and any challenges you faced and overcame. Discuss your familiarity with standard operating procedures and any innovations you contributed to enhancing efficiencies.

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What steps do you take to ensure compliance with cGMP regulations?

Explain the importance of cGMP compliance in biomanufacturing and outline the processes you follow to ensure adherence, such as meticulous documentation, following established protocols, and regular reviews of batch records to maintain safety and quality standards.

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Describe a time when you had to troubleshoot a bioreactor issue.

Share a specific example where you faced a problem with a bioreactor, detailing how you identified the root cause and the steps you took to resolve it. Highlight your analytical skills, teamwork, and communication throughout the troubleshooting process.

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How do you prioritize tasks when managing multiple projects?

Discuss your time management strategies, such as using tools to track progress, setting clear deadlines, and communicating with team members about priorities. Emphasize your ability to adapt to changing circumstances while maintaining focus on quality.

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What is your experience with single-use manufacturing technologies?

Talk about your hands-on experience with single-use manufacturing consumables and how you used them in previous roles. Highlight benefits you’ve observed in efficiency, flexibility, and contamination risk reduction that these technologies provide.

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How do you handle conflicts within a project team?

Illustrate your conflict resolution skills by providing an example of a past situation where you addressed a disagreement. Focus on how you facilitated communication and collaboration to reach a mutually acceptable solution while maintaining project goals.

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What metrics do you utilize to assess process performance?

Explain the key performance indicators you monitor in bioprocessing, such as yield, viability, and productivity metrics. Discuss how you track these metrics and utilize them for continuous process improvement and scalability.

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Can you provide an example of a successful scale-up project you’ve been involved in?

Share details of a particular scale-up project where you played a critical role, detailing your contributions, the outcomes, and any lessons learned that were applicable as you transitioned from pilot to full-scale production.

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How do you stay current with advances in biomanufacturing technology?

Discuss your commitment to continuous learning, such as attending industry conferences, participating in webinars, following relevant publications, and networking with peers. Highlight how this knowledge helps enhance your contributions in the Upstream Manufacturing Scientist role.

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Tell me about a challenge you faced in a GMP environment and how you overcame it.

Reflect on a specific instance where you encountered a challenge in adhering to GMP practices. Describe the situation, your thought process, and the steps you implemented to resolve it, ensuring that you maintained compliance and safety throughout.

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TEAM SIZE
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HQ LOCATION
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EMPLOYMENT TYPE
Full-time, on-site
DATE POSTED
April 18, 2025

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