Manufacturing Master Associate, Downstream

Downstream Processing 

The purification of proteins from the cell culture supernatant using chromatography (including for affinity, anion/cation exchange and hydrophobic interaction), filtration, extraction, virus inactivation, virus filtration and protein modification is a crucial step in the production of your active ingredients. We know the requirements for a wide range of therapeutic proteins such as monoclonal antibodies and fusion proteins and can reliably map the efficiency and robustness of the process steps for your active ingredient to enable you to access the market quickly.

Executes and coordinates unit operations in Downstream manufacturing as assigned related to the manufacturing of bulk drug substances in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures. Serves as an operations subject matter expert (SME) representing the department during audits, new product introductions, and technical assessments.

Executes independently with adequate training fundamental operations:

-CIP/SIP of tanks, transfer lines, and process equipment.

-Buffer preparation and transfer into tanks and disposables.

-Performs In process testing for samples e.g. spectrophotometry, pH, conductivity, and maintenance of analytical equipment.

This may include parts cleaning and weigh and dispensing.

Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.

Documents work according to cGMP and cGDP.

Adheres to established regulations and follows cGMP established by site.

Reports abnormalities and deviations in a timely and accurate manner.

Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.

Maintains production areas according to predefined standards

Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification. Conducts group trainings on complex topics and scientific principles as needed.

Contributes to Quality activities as investigations and area walk-throughs.

High- strong focus on execution of tasks with high technical complexity. Performs non-routine tasks to support troubleshooting or validation activities. Identifies process anomalies and areas for improvement for complex, critical operations.

High interactions:

Manufacturing Cell Culture, Manufacturing Purification, Manufacturing Compliance, Engineering & Technology, Supply Chain, Quality Assurance, Quality Control, MSAT, Validation

Subject Matter Expert of bio-pharmaceutical manufacturing practices, as well as a high technical knowledge of biologics principles required.

4 or more years of experience in cGMP regulated industry.

-Ability to concentrate on detail-oriented work in a complex technical setup with a Quality and Right the first time mindset.

-Strong written and verbal communication skills.

-Ability to work with computer-based systems and ideally experience with process control systems (e.g. Delta V) and manufacturing execution systems (MES).

-Ability to read and understand SOPs and work instructions and document work in a written format applying cGMP standards.

-Ability to work as part of a high performing team and collaborate effectively with staff.

Requirements

Equipment used in downstream manufacturing includes: 

• Affinity chromatography: A chromatographic method that separates and concentrates a product by binding it to a column 
  
• Ultrafiltration: A method that concentrates a dilute product stream by separating molecules based on their size or molecular weight 
  
• Diafiltration: A method that exchanges a product into a desired buffer 
  
• Chromatographic clarifiers: A type of equipment used in downstream processing 
  
• ViewCell Flow Cell: A component for biopharmaceutical process control 
  
• Spray dryers: A type of equipment used in downstream processing 
  
• Vacuum dryers: A type of equipment used in downstream processing 
  
• Freeze dryers: A type of equipment used in downstream processing 
  
• Supercritical CO2 extractors: A type of equipment used in downstream processing 
  
• Packing machines: A type of equipment used in downstream processing 
  

Downstream processing equipment can vary in size and complexity, from laboratory systems to production scale. The equipment's complexity generally decreases with the scale, but even larger-scale equipment should be flexible enough to address different production scenarios.