USP Manufacturing Associate

As a USP Manufacturing Associate, you will execute upstream processes, such as cell culture and bioreactor operations, while collaborating with engineers and manufacturing associates to ensure that engineering and clinical batches are completed on time. You'll also be involved in developing and optimizing manufacturing techniques, adhering to GMP protocols, and reviewing batch records to ensure accuracy.

To qualify for the USP Manufacturing Associate role, candidates should possess a Bachelor’s or Master’s degree in chemical, biological, or biochemical sciences, along with a minimum of 2 years of experience in the biopharmaceutical industry, specifically focusing on upstream processes and cGMP environments.

Success in the USP Manufacturing Associate role requires excellent interpersonal and communication skills, meticulous attention to detail, strong organizational abilities, and proficiency in computer applications like Word, Excel, and spreadsheets. Being able to work both independently and collaboratively with a team is also crucial.

A USP Manufacturing Associate will work with mammalian cell culture processes, executing cell culture batches and conducting operations in bioreactors. Familiarity with single-use consumables, such as bags and tube sets, is essential, as is the ability to collect and analyze operational data to make real-time adjustments.

The working environment for a USP Manufacturing Associate is a cGMP-compliant facility focused on biopharmaceutical manufacturing. You will adhere to strict environmental health and safety standards while collaborating with fellow associates and engineers to ensure successful batch execution.

When discussing your experience with bioreactor operations, be prepared to share specific examples of the types of bioreactors you've worked with, the scales of operations, and what processes you executed. Highlight any challenges faced and how you overcame them, as well as your understanding of cGMP compliance.

To ensure adherence to GMP protocols, explain that you maintain meticulous documentation, follow established procedures, and participate in regular training. Mention any specific experiences where attention to detail helped prevent issues or ensured compliance.

When asked about handling data analysis, detail your ability to collect and interpret operational data. Explain your approach to making real-time adjustments based on this data and provide examples of how this has positively impacted batch outcomes.

Discuss specific challenges, such as equipment malfunctions or batch variabilities, and the actionable steps you took to address them. Emphasize your problem-solving skills and commitment to producing quality biopharmaceutical products.

Provide examples of past experiences where you successfully collaborated with team members, both in problem-solving and daily operations. Emphasize the importance of communication and how you prioritize teamwork in reaching production goals.

Discuss any methodologies or processes you’ve implemented to enhance manufacturing techniques. Highlight your ability to assess existing techniques and introduce modifications that improve efficiency, output, or quality.

To effectively answer this, highlight your familiarity with documenting batch records, standard operating procedures (SOPs), and any other compliance-related documentation. Detail how you ensure accuracy and completeness in your documentation work.

Provide a specific example where you detected a problem, describe your immediate actions to address it, and the outcome. Highlight your critical thinking and ability to work under pressure to resolve issues quickly.

Discuss any subscriptions to industry publications, participation in workshops or conferences, or involvement in professional organizations related to biopharmaceuticals to show your commitment to continuous learning.

This is a great opportunity to showcase your knowledge. Discuss the importance of cleaning verification and validation processes in maintaining cGMP compliance and ensuring that all equipment remains free of contaminants before batch execution.