Associate Manager, Purification Manufacturing

POSITION SUMMARY

We are seeking a passionate and capable Associate Manager to support Purification Operations within our Manufacturing team for our early-stage cell/gene therapy GMP manufacturing facility located in Louisville, CO.

This role is responsible for leading the operations and continuous improvement of manufacturing programs and operating systems in downstream and solution preparation.  Primary job responsibilities include, but are not limited to, new hire onboarding, personnel development, purification unit operation execution, equipment maintenance, material management, personnel gowning, implementing personnel/material flow, batch records review, production scheduling, onboarding new manufacturing processes/products, and assisting in the implementation of facility quality systems. Success is measured by successful downstream execution, personnel staffing finite coverage, personnel development, and continuous improvement initiatives implemented.

This role will interact on a regular basis with internal process engineers, Process Sciences, Facilities, Supply chain, EHS, Quality Assurance, and Quality Control. Strong communication skills are essential to effectively work in this matrix 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 at our Louisville, CO location. The schedule for this role will be determined upon offer extension. It will either be Monday-Friday, 8 am to 5 pm or a 4x10 schedule with an option of Monday-Thursday or Tuesday-Friday. This person will need to be able to work weekends, holidays, or evenings when needed.

CORE ACCOUNTABILITIES

Specific responsibilities include: 

• Manage, mentor, and develop a team of high performing manufacturing associates at varied levels.
• Leads the execution and improvement of compliant manufacturing process procedures, programs, and systems in support of GMP manufacturing operations
• Authors and reviews-controlled documents and standard operating procedures on behalf of Manufacturing Operations
• Actively partners with Process Sciences to lead successful technology transfer of novel cell/gene therapy manufacturing processes at various scales, with a focus on purification process steps (i.e., chromatography, TFF, buffer prep).
• Assists in deviation investigations
• Leads activities related to the introduction of new raw materials specifications from draft through approval
• Ensures adherence to Standard Operating Procedures, good manufacturing practices, and good documentation practices
• Responsible for ensuring personnel training qualification and trainer status to enable operations
• Participates in equipment, process, and system validation activities including Environmental Monitoring Performance Qualification (EMPQ), and IQ/OQ/PQ of Manufacturing equipment and systems
• Performs aseptic manufacture of lentiviral products in an aseptic clean-room environment (ISO5, ISO7, ISO8, ISO9)
• Ensures maintained inventory and performs stocking activities for gowning, cleaning, and consumable materials to ensure sufficient inventory is available to support manufacturing operations
• Leads solution and buffer prep operations in a clean-room environment (ISO9)
• Ensures development of operating schedules and ensures schedule adherence for manufacturing task execution
• Hiring and onboarding any new team members required to meet goals
• On-the-floor Manufacturing support and execution as needed approximately 50% of time
• Other duties as needed

The successful candidate will have:

• Associate Manager Level: Bachelor’s degree in a related life-science field, or equivalent in work experience with 8+ years of cGMP manufacturing experience in the pharmaceutical, biologics, and/or medical device field is desired or equivalent in work experience or education with a minimum of 2 years of people management experience.
• Manager Level: Bachelor’s degree in a related life-science field, or equivalent in work experience with 10+ years of cGMP manufacturing experience in the pharmaceutical, biologics, and/or medical device field is desired or equivalent in work experience or education with a minimum of 4 years of people management experience.
• Prior experience in the downstream purification areas of chromatography and tangential flow filtration
• Prior experience in Weigh and Dispense and solution preparation areas
• Prior management/team leadership experience in a manufacturing environment

Preferred Qualifications:

• Prior experience receiving a technology transfer is strongly preferred
• Prior commercial manufacturing experience is strongly preferred
• Commercial launch and audit experience
• Prior experience assisting in deviation investigations and CAPAs
• 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 holidays, nights and weekends as needed

Salary Range:

Associate Manager Level- $107,100 - $132,300

Manager Level - $125,300 - $154,800