Bioprocessing Specialist, Drug Product

POSITION SUMMARY

We are seeking a passionate and capable Bioprocessing Specialist, Drug Product (DP) to support Manufacturing Operations at our newly constructed early-stage cell/gene therapy GMP manufacturing facility located in Louisville, CO.

This role will collaborate with other functions to develop and establish the Drug Substance (DS) and Drug Product (DP) processes.  Primary job responsibilities include, but are not limited to, DS/DP processing equipment onboarding, qualification, and management, material management, personnel gowning, facility cleaning, authoring reviewing and executing batch records, production scheduling, training and/or leading staff, aseptic processing, vial visual inspection, and onboarding new manufacturing processes/products. This role will support routine Manufacturing Operations. 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 role will be fully onsite. The schedule for this role will either be Monday-Thursday or Tuesday-Friday operating on a 4x10 schedule. This person will need to be able to work weekends, holidays, or evenings when needed.

CORE ACCCOUNTABILITIES:
Specific responsibilities include:  

• Mentor and coach junior associates during the authorship of controlled documents and standard operating procedures on behalf of Manufacturing Operations.
• Lead GMP Manufacturing operations on the floor when Manager is not present
• Perform on-the-job training of associates as a Qualified Trainer for DS/DP unit operations
• Execution of Fill/Finish procedures 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.
• Observe, perform, and qualify on aseptic process simulations and initial internal technology transfer runs
• Able to pass visual acuity tests and drug product visual inspection qualification
• Revise processing SOPs, equipment SOPs, and batch records as necessary
• Perform aseptic manufacturing of lentiviral products in an aseptic clean-room environment (ISO5, ISO7, ISO8, ISO9)
• Proactively engage and collaborate with cross-functional partners to ensure timely and successful completion of DS/DP process simulations and initial internal technology transfer runs from Process Sciences to Manufacturing
• Perform activities related to the introduction of new raw materials, bulk drug substance, and drug product specifications from draft through approval.
• Perform equipment cleaning, as required, per routine maintenance events, and pre/post process requirements
• Adhere to Standard Operating Procedures, good manufacturing practices, and good documentation practices.
• Revise and/or create processing SOPs, equipment SOPs, and batch records
• Perform and participate in equipment, process, and system validation activities including Environmental Monitoring Performance Qualification (EMPQ), and IQ/OQ of Manufacturing equipment and systems.
• Perform and oversee aseptic processes, including but not limited to sterile filling of lentiviral DS/DP 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 and oversee material management activities related to the kitting of Bill of Materials items.
• Other duties as needed 

The successful candidate will have:

• Bachelor’s degree in a related biotechnology or life-sciences field with 6 years of cGMP manufacturing experience in the pharmaceutical and/or biologics field; OR equivalent combination of education and experience will be considered
• GMP Drug Substance / Drug Product Filling experience
• Vial Visual Inspection experience
• Leadership experience such as informal team lead, trainer, etc.
• Experience receiving a technology transfer

Preferred Qualifications:  

• Viral vector experience is preferred
• Ability to troubleshoot issues of moderate scope independently
• Ability to independently develop work plans and schedules to ensure the timely completion of assignments and deliverables
• Demonstrated experience leading 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
• Ability to pass visual inspection eye exam
• 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 evenings, holidays, and weekends as needed 
• Ability to work on call as needed

Hourly Range: $43.52 - $53.76. This is a non-exempt position and is overtime eligible.