This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
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