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Sr Manufacturing Associate, Downstream

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Proclinical

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Location:
United States , Bristol

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

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Job Description:

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.

Job Responsibility:

  • 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

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

Additional Information:

Job Posted:
March 20, 2026

Employment Type:
Fulltime
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