Senior Bioprocessing Associate, Downstream

POSITION SUMMARY

We are seeking a passionate and capable Sr. Bioprocessing Associate to support downstream Manufacturing Operations at our early-stage cell/gene therapy GMP manufacturing facility located in Louisville, CO. This role will support routine Manufacturing Operations and primarily focus on the downstream purification of our process, however, could be expected to support other manufacturing functions as well.

Primary job responsibilities include, but are not limited to, executing buffer prep, chromatography, and TFF batch records, material management, personnel gowning, adhering to personnel/material flow, facility cleaning, onboarding new manufacturing processes/products, and assisting in the implementation of facility quality systems. Success is measured by full qualification on downstream manufacturing unit operations and successful execution to create lentiviral drug products.

This role will interact on a regular basis with internal process engineers, Process Sciences, facilities, warehouse/supply chain, EHS, Quality Assurance, and Quality Control. Strong communication skills are essential to effectively work in our matrix team environment. This is an opportunity to be part of an excellent team working in an exciting environment, focused on realizing the challenge of targeting solid tumors successfully with novel cell/gene therapies.    

This is a fully onsite role at our Louisville, CO site. This role will start as 5 days/week and convert to a 4x10 schedule after completing onboarding/training.

CORE ACCOUNTABILITIES

Specific responsibilities include:    

• Adhere to Standard Operating Procedures, good manufacturing practices, and good documentation practices. Revise processing SOPs, equipment SOPs, and batch records as necessary
• Perform weigh/dispense and buffer prep operations in a clean-room environment (ISO9)
• Observe, participate, and perform in downstream unit operation execution, and initial internal technology transfer runs from Process Sciences to Manufacturing
• Assist in the implementation of compliant and technically sound programs and systems in support of GMP manufacturing 
• Actively participate in the receipt of internal technology transfer of novel cell/gene therapy manufacturing processes at various scales. 
• Perform activities related to the introduction of new raw materials specifications from draft through approval
• Perform equipment cleanings, as required, per routine maintenance events, and pre/post process requirements.
• Perform aseptic manufacture of lentiviral products in an aseptic clean-room environment (ISO5, ISO7, ISO8, ISO9)
• Maintain inventory and perform stocking activities for gowning, cleaning, and consumable materials to ensure sufficient inventory is available to support manufacturing operations
• Perform material management activities related to kitting of Bill of Materials items
• Other duties as needed  

The successful candidate will have:

• Associate’s degree/Bachelor’s degree in a related biotechnology or life-sciences field with 5/3+ years of cGMP manufacturing experience (respectively) in the pharmaceutical and/or biologics field is desired or equivalent in work experience or education 
• Prior Commercial GMP manufacturing experience is required 
• Downstream purification knowledge or experience is required (e.g., depth-filtration, tangential flow filtration, and/or chromatography), specifically Cytiva’s AKTA Ready and Repligen’s KMPi systems. 

Preferred Qualifications: 

• Prior Commercial launch GMP manufacturing experience preferred
• Prior experience receiving a technology transfer is a bonus 
• Demonstrated experience working on results-oriented teams where contribution and collaboration were critical to project success
• Proficient in computer applications such as word processing, spreadsheets, and web-based applications
• Self-motivated with strong organization and communication skills and can work independently or as part of a multi-disciplinary matrixed team.  

Physical Requirements:    

• Ability to gown aseptically and work in a Clean Room environment 
• Ability to work while gowned for extended periods of time 
• Extensive use of laboratory equipment includes handling chemicals and biological materials
• Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10-20 lbs. and periodically lift up to 50 lbs.
• Ability to work nights and weekends as needed  
• Ability to work holidays and on-call as needed

Salary Range: $36.06 – $44.57/hour This is a non-exempt role.