Downstream Manufacturing Scientist

This dynamic role is integral to the purification of mammalian cell-based cultures and the production of recombinant proteins for a variety of mammalian-based biosimilars. The position involves purifying volumes from 50L to 1000L for engineering, clinical, and commercial batches in a cGMP environment.

The successful candidate will possess extensive technical expertise in AKTA purification skids or similar systems, tangential flow filtration (TFF), and a thorough understanding of batch records, protocols, investigations, and other technical documents.

Essential Duties & Responsibilities:

• Perform and oversee downstream processes at various scales in a cGMP environment, including column packing, process troubleshooting, and data analysis.
• Provide technical guidance in the execution and development of the purification process.
• Utilize programs to collect and assess operating data, making online adjustments to products, instruments, or equipment as needed.
• Prepare and review all quality management-related documents (Deviation, Change control, investigation reports, etc.).
• Ensure timely execution of engineering and clinical batches.
• Establish operating equipment specifications and enhance manufacturing techniques.
• Collaborate with other teams and external vendors to resolve technical issues and maintain production equipment.
• Adhere to GMP instructions in the manufacturing area and lead compliance with environmental health and safety policies.
• Coordinate investigations and corrections for issues identified during the batch execution process.
• Perform additional functions as required or assigned.
• Comply with all company policies and standards.

Requirements:

• Education: Bachelor’s or Master’s degree in chemical, biological, or biochemical sciences with 8-12 years of related experience in the biopharmaceutical industry.
• Prior experience in GMP and aseptic manufacturing environments.
• Experience with AKTA Process skids or similar systems, and familiarity with single-use manufacturing consumables (e.g., bags, tube sets, columns, process manifolds).
• Proficiency in executing engineering and clinical batches and familiarity with GMP documentation.

Work Environment & Physical Demands:

• General work environment and physical demands necessary to perform essential functions.
• Flexibility to work varied hours as needed.
• Ability to work under pressure and meet deadlines.
• Some travel may be required.