Job details

USP Bioprocessing Specialist III

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The role will involve performing upstream manufacturing to ensure that the process is robust, scalable, and successfully executed in the manufacturing facility – as well as the accompanying documentation. The successful candidate will be familiar with cGMP regulations and technology transfer tasks and work out of the brand-new state-of-the-art facility in New Jersey, USA.

This position requires great attention to detail, the ability to work in a team environment, and a keen interest in the optimization of processes. Scientists will be responsible for adhering to all Quality Management System procedures, safety policies, and relevant parts of cGMP.

Location: On-site, USA - New Jersey

Type: Full-time

Responsibilities:

Optimize bioreactor performance and scale-up procedures to meet production goals and maintain product quality.
Develop and refine operating equipment specifications and implement improvements to upstream manufacturing techniques.
Work collaboratively with a team of manufacturing associates and engineers to execute upstream batches efficiently.
Establish and refine operating equipment specifications to enhance manufacturing techniques.
Interpret and communicate instructions in various formats (written, verbal, diagrammatic) to ensure clarity and compliance.
Follow GMP guidelines and lead efforts to maintain environmental health and safety policies in the manufacturing area.
Review executed manufacturing and packaging batch records along with supporting documents for accuracy and compliance.
Coordinate investigations and corrective actions for any issues identified during the batch execution process.
Perform additional functions as required to support team objectives and compliance with all company policies and standards.

Experience/Qualifications:

Bachelor’s or Master’s degree in chemical, biological, or biochemical sciences with a minimum of 3+ years of relevant experience in the biopharmaceutical sector.
Proficiency in independently planning, executing, analyzing, and documenting all phases of process development.
Strong foundational knowledge and expertise necessary to manage engineering and clinical batches.
Previous experience in GMP and aseptic manufacturing settings.
Familiarity with single-use manufacturing consumables, including bags, tube sets, columns, and process manifolds.

Average salary estimate

$80000 / YEARLY (est.)

min

max

$70000K

$90000K

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What You Should Know About USP Bioprocessing Specialist III, Pharma Universe

As a USP Bioprocessing Specialist III at our cutting-edge facility in New Jersey, USA, you will take the lead in performing upstream manufacturing processes that are both robust and scalable. Your role is pivotal to ensure that each process is executed flawlessly and documented meticulously. You'll dive into optimizing bioreactor performance while collaborating with a talented team of manufacturing associates and engineers. If you have a solid understanding of cGMP regulations and love the intricacies of technology transfer, this position will be right up your alley! You can expect to be hands-on, developing and refining equipment specifications and enhancing manufacturing techniques. The activity is not just about following procedures but actively engaging in the optimization of our processes to meet production goals while maintaining outstanding product quality. Your attention to detail will shine as you review batch records and facilitate any corrective actions needed during production. This role requires a spirit of teamwork, so if you thrive in collaborative environments and have the keen interest to push the boundaries of biopharmaceutical processes, we’d love to hear from you. Join us in shaping the future of health care at our state-of-the-art facility where innovation meets dedication.

Frequently Asked Questions (FAQs) for USP Bioprocessing Specialist III Role at Pharma Universe

What are the key responsibilities of a USP Bioprocessing Specialist III at our company?

As a USP Bioprocessing Specialist III, your responsibilities will include optimizing bioreactor performance, developing equipment specifications, and collaborating with teams to efficiently execute upstream batches. You will also be tasked with ensuring compliance with cGMP regulations and leading efforts to maintain quality and safety standards in our manufacturing area.