Manufacturing Associate II, Bioconjuation

Manufacturing Associate II, Bioconjuation - Contract - Bristol PA

Are you ready to take your next step in your manufacturing career? This position performing large-scale bioconjugation processes for cGMP manufacturing projects is your next step!

Primary Responsibilities:

This position performs functions related to the manufacturing, development, and processing of drug substances, ensuring product compliance and multiple tasks that ultimately provide Good Manufacturing Practices and on time delivery to the customer. The individual must be able to communicate production status, communicate problems to proper personnel and understand how it affects other aspects of the operation.

Skills & Requirements:

• Bachelor's degree in chemistry, biology or engineering.
• A minimum of 2 years' experience in a GMP pharmaceutical environment
• Experience in normal flow filtrations and tangential flow filtrations (UF/DF).
• Experience with optimization of bioprocesses
• Direct hands-on experience with preparative chromatography systems (AKTA Pilot, AKTA Ready, AKTA Explorer, etc.), and manual or automated TFF skids.
• Experience with cGMP manufacturing operations and GxP principles.
• Understanding and application of cGMP requirements.

The Manufacturing Associate's responsibilities will be:

• Set up, operate, and clean manufacturing rooms and equipment.
• Utilize personal safety equipment and engineering controls effectively.
• Support investigational and quality systems activities.
• Assist with preventative maintenance, troubleshooting, and equipment repair.
• Collaborate with process development, Quality Control, and Quality Assurance teams.
• Initiate deviations and assist in assessing product quality impacts.
• Write and review Standard Operating Procedures (SOPs) and other cGMP documentation.
• Execute Master Batch Records and validation protocols accurately.
• Maintain equipment logs and batch records.
• Ensure cleanliness and proper assembly of equipment and areas.
• Train on and understand all relevant policies and procedures.
• Communicate effectively with clients, supervisors, and colleagues.
• Participate as a team player in all business aspects.
• Adhere to quality standards set by regulations and company policies.

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

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