Biopharmaceutical Production Supervisor

2 weeks ago


Piscataway, New Jersey, United States Global Life Science Hub Full time
Position Overview

We are seeking a Biopharmaceutical Production Supervisor to take on a pivotal role in the purification processes of mammalian cell-derived cultures and the synthesis of recombinant proteins aimed at biosimilars. This role encompasses managing purification volumes ranging from 50L to 1000L for various batch types within a cGMP setting. Proficiency in AKTA purification systems, tangential flow filtration (TFF), and a solid understanding of batch records and technical documentation are crucial.

Key Responsibilities:

  • Oversee and execute downstream manufacturing processes at multiple scales within a cGMP framework, including column packing, troubleshooting processes, and analyzing data.
  • Offer technical guidance for purification methodologies.
  • Gather and assess operational data, making real-time adjustments to products, instruments, or equipment as necessary.
  • Draft and review quality management documentation (such as Deviation Reports, Change Controls, and Investigation Reports).
  • Ensure the prompt execution of engineering and clinical production batches.
  • Define equipment specifications and enhance manufacturing practices.
  • Work collaboratively with cross-functional teams and external partners to address technical challenges and maintain production apparatus.
  • Champion GMP compliance and adhere to environmental health and safety regulations.
  • Lead investigations and implement corrective actions for any issues encountered during batch production.
  • Perform additional assigned tasks while adhering to all organizational policies and standards.

Qualifications:

Educational Background:

  • Bachelor's or Master's degree in chemical, biological, or biochemical sciences.
  • 7-10 years of relevant experience in the biopharmaceutical sector.
  • Experience in GMP and aseptic production environments.
  • Familiarity with AKTA Process systems and single-use manufacturing materials.

Essential Skills:

  • Strong interpersonal abilities and capacity to work autonomously.
  • Exceptional communication, documentation, and organizational skills.
  • Proficiency in Microsoft Word, Excel, and other spreadsheet applications.
  • Understanding of GMP batch production, packaging documentation, and cleaning verification/validation processes.

Work Environment & Physical Requirements:

  • Willingness to work flexible hours as required.
  • Able to perform under pressure and meet tight deadlines.
  • Some travel may be necessary.


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