Sr Manufacturing Associate, Downstream

Sr Manufacturing Associate, Downstream - Permanent - Bristol PA

Be the driving force behind seamless logistics with our client where precision and efficiency are key to supporting world-class manufacturing.

Proclinical is seeking a Sr Manufacturing Associate to be responsible for performing large-scale bioconjugation processes for cGMP manufacturing projects.

Primary Responsibilities:

This position includes performing 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 6+ 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 Sr Manufacturing Associate's responsibilities will be:

• Works in GMP environment and ensures regulatory compliance.
• Performs Manufacturing activities including:
  • Performs a variety of complex tasks in accordance with cGMP, cGDP, SOPs, and Batch Records
  • Batch Documentation/Record Generation
  • Materials sampling, staging, dispensing, and return
  • Equipment and Room set-up, operation, and cleaning
  • Use of appropriate personal safety equipment and engineering controls
  • In-process inspection and sampling
  • Support investigational and quality systems activities
  • Assist maintenance in the performance of preventative maintenance activities, troubleshooting and repair of equipment
  • Participate in continuous improvement activities
• Interfaces and consults with other functions, such as process development, Quality Control and Quality Assurance
• Initiates deviations, assists in assessing product quality impact and assists with proposals for Corrective and Preventive Actions (CAPAs)
• Writes, reviews SOPs and other applicable cGMP documentation for Manufacturing
• Ensures proper execution of Master Batch Records, standard operating procedures, and validation protocols
• Ensures completion of equipment logs and batch records
• Ensures cleanliness and proper assembly of manufacturing equipment and manufacturing areas per approved procedures (SOP's)
• Ensures accuracy of Standard Operating Procedures (SOP's)
• Trains on and understand all policy and procedures including Regulatory, Safety, SOPs, Work Instructions, etc.
• Operate to the highest ethical and moral standards.
• Comply with our policies and procedures.
• Communicate effectively with clients, supervisors, colleagues and staff.
• Participate effectively as a team player in all aspects of our business.
• Adhere to quality standards set by regulations and our policies, procedures, and mission.
• Perform other duties as assigned.

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at [email protected]

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.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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