Manufacturing Downstream Associate I​/II

Manufacturing Downstream Associate

The Manufacturing Downstream Associate is a hands-on position responsible for manufacturing operations that executes downstream processing tasks to purify recombinant proteins for a wide range of mammalian-based biosimilars. The employee will be responsible for purification of harvest material scale sizes 50L to 2000L within strict cGMP environments and execute strict quality documentation.

Key responsibilities of the position include, but are not limited to –

• Demonstrate a sound knowledge and understanding of cGMP requirements. Adhere to real-time documentation during production run and maintain accurate records/logs.
• Set up, operate, and break down downstream equipment including chromatography columns, controllers, and TFF systems.
• Perform downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting, and data analysis.
• Perform calculations for processing, weighing materials, chemical and reagent additions.
• Uses programs to collect and evaluate operating data to conduct online adjustments to products, instruments, or equipment.
• Works with other teams and outside vendors to resolve technical issues as well as maintenance of production equipment.
• Follow all GMP instructions in the manufacturing area and take responsibility / ownership of environmental health and safety policies.
• Coordinate the conduction of investigations and corrections for issues found during the batch execution process.
• Comply with all company policies and standards. Ensuring all operations comply with cGMP, safety, and data integrity standards.
• Performs other functions as required or assigned.
• Revision of solution preparation batch records, SOPs, Protocols and logbooks.
• Providing support during quality audits and regulatory inspections.

Material & Inventory Management

• Order, maintain, track, and staging of raw materials and consumables for upstream, downstream, and media/buffer preparation processes.
• Perform label verification, receipt checks, and electronic inventory updates.
• Coordinate with warehouse and planning teams for material readiness.
• Managing material inventory inside cleanroom areas.

Requirements

Position Requirements and Qualifications

Minimum Qualifications:

• Education:
  
  High school diploma or equivalent required. Bachelor's degree preferred.
• Experience in a manufacturing environment or 1-2 years of relevant experience preferred.
• Familiarity with safety protocols/procedures
• Ability to understand and adhere to written and verbal instructions. Excellent written and verbal communication skills. Ability to communicate technical details at all levels, including senior leadership
• Ability to work well with a wide range of people from other groups in a team-oriented environment with cross-functional groups.
• Ability to learn to properly use various hand and electrical tools.
• Ability to work in a fast-paced environment and handle changing manufacturing demands.
• Proficient in MS Word, Excel, and PowerPoint.
• Ability to troubleshoot technical issues and propose short- and long-term solutions.
• Strong time-management skills and the ability to work under demanding timelines.
• Work in a team environment and be able to work independently with minimum supervision.
• Ability to learn to proper use of various hand and electrical tools.

Preferred Qualifications:

• The preferred candidate would have general working knowledge in AKTA purification skids or similar, tangential flow filtration (TFF), columns, and single-use consumable technologies such as bags, tube sets, columns. and process manifolds
• Previous hands-on experience working mammalian cell line in a GMP and aseptic commercial manufacturing setting with biopharma or biotech.
• Proficiency in aseptic operations and in-process sampling.

Additional Position Information:

• As a biosimilar company, our schedules are driven by process requirements. The need for support of manufacturing activities may run through weekends or outside of normal business hours.

o Regular office hours: 09:00 AM to 05:30 PM.

o Manufacturing shifts: 12hr non-rotating shifts for 24/7 coverage, including holidays and weekends.

Shift: Non-Rotating 12 Hour shift – (Shift A -…