Upstream Manufacturing Scientist (Night shift)

As an Upstream Manufacturing Scientist, you will be responsible for executing mammalian cell culture processes and managing bioreactor operations to produce recombinant proteins for biologics. This includes handling batches of up to 2000L, collaborating with fellow associates and engineers, and maintaining rigorous documentation in a cGMP environment. Your role will also involve the initiation and oversight of batch records and protocols to ensure compliance with safety and quality standards.

To qualify for the Upstream Manufacturing Scientist role, candidates should possess at least 1-2 years of experience in cell culture and bioreactor operations, preferably in a GMP and aseptic manufacturing environment. Familiarity with single-use manufacturing consumables and experience in scale-up manufacturing activities are advantageous and will enhance your candidacy for this position.

The Upstream Manufacturing Scientist position is available for the night shift as we expand our operations at our new facility in New Jersey. This is a critical time for our teams as we gear up for full-scale commercial production, making it an exciting opportunity for those looking to join a growing organization.

The work environment for an Upstream Manufacturing Scientist is dynamic and collaborative, set within a cGMP-compliant manufacturing facility. You will work closely with a range of professionals in a laboratory setting, emphasizing safety, quality, and efficiency as you run bio-manufacturing processes and ensure that all operations meet regulatory standards.

There are abundant growth opportunities for Upstream Manufacturing Scientists within our organization. With the rapid scaling of our manufacturing capabilities, employees can expand their expertise, take on more responsibilities, and advance through various levels of the manufacturing team, from foundational roles to more senior positions as they gain experience and knowledge in the industry.

When discussing your experience with bioreactor operations, focus on specific examples of the types of bioreactors you have worked with, the scale of production, and any innovations or improvements you implemented. Highlight your understanding of operational parameters and how you ensured compliance with GMP standards.

It's vital to outline the safety protocols you've adhered to in a cGMP environment. Discuss your familiarity with documentation practices, how you maintain sterility, and your approach to follow SOPs during manufacturing processes to mitigate risks.

Employ a structured approach to troubleshooting by outlining the steps you take when faced with issues in cell culture processes. Discuss your method for identifying root causes, the importance of documentation, and collaboration with team members to develop solutions.

Share specific examples of your experience with single-use manufacturing consumables, detailing the types you have used and how they have affected the efficiency and effectiveness of your processes. Highlight any benefits you’ve observed, such as reduced contamination risk or easier clean-up.

Choose a specific example that demonstrates your critical thinking and problem-solving abilities. Discuss the challenge, the steps you took to address it, and the outcome, emphasizing what you learned from the experience.

Discuss your commitment to regulatory compliance and your understanding of the relevant regulations. Explain how you incorporate these requirements into your daily tasks, such as following SOPs, conducting regular audits, and maintaining thorough documentation.

Highlight collaborative projects emphasizing teamwork and communication. Describe your role, the project objectives, and outcomes, illustrating your ability to work effectively with others toward common goals in a manufacturing environment.

Share specific strategies you use to stay informed, such as attending industry conferences, participating in professional networks, or following relevant journals and publications. Highlight any recent advancements that excite you and how you would like to implement them.

Discuss your experience with specific techniques such as process optimization, workflow mapping, or Lean manufacturing principles. Provide examples of how you have applied these techniques in past roles and what outcomes they yielded.

Reflect on your passion for biotechnology and the role it plays in improving lives. Share specific motivations, such as the opportunity to contribute to groundbreaking therapies and innovations in manufacturing processes. This illustrates your commitment to the field.