Job Summary:

This position is a full-time, Intermediate thru Principal Professional-level (open rank) position at the Gates Biomanufacturing Facility located on the Anschutz Medical Campus and serves on the Protein Biologics team. This position is The Process Development/Manufacturing Associate is responsible for supporting manufacturing of biologics-based therapeutics and participating all cross functional activities including but not limited to Process Development (PD) and Process Engineering (PE) to develop, scale-up, and transfer new products to cGMP manufacturing. This position will report to the Supervisor of Biologics Process Development and Manufacturing.

Key Responsibilities:

Process Development and Manufacturing Associate I:

• Execute recombinant protein manufacturing processes at development, pilot scales and engineering run including buffer, media and solution preparation, fermentation, cell lysis, chromatography and ultrafiltration.
• Execute analytical methods for protein characterization including UV-Vis spectroscopy, SDS-PAGE and HPLC.
• Execute molecular biology techniques related to DNA plasmid production, nucleic acid modification, and in vitro transcription. Perform analysis of nucleic acid by gel. Electrophoresis and HPLC.
• Lead and manage in the scale-up or transfer of protein manufacturing processes to the cGMP suites including batch record drafting and material specifications.
• Draft and edit Batch Records, Bill of Materials, SOP, Forms for Process Development and cGMP manufacturing documentation.
• Responsible for the review, approval of GMP documentation and subsequent training.
• Document manufacturing using Good Documentation Practices, conduct reviews.
• Maintain laboratory notebooks, cGMP documents, logs, Quality system and computer databases
• Manage tasks to meet project expectations related to timelines, budget, and quality.
• Collaborate with cross functional teams including Project Management, Process Development, Supply Chain, Quality and Facilities and Finance to coordinate interdepartmental communication and shared activities.

Process Development and Manufacturing Associate II: In addition to the responsibilities above, appointments at this level will…

• Execute molecular biology techniques related to DNA plasmid production, nucleic acid modification, and in vitro transcription. Perform analysis of nucleic acid by gel electrophoresis.
• Coordinates resources and executes tech transfer and scale-up plans with technical leads and/or project managers.
• Performs manufacturing activities according to cGMP guidelines, including batch record execution line clearance
• Ensures safety and cGMP compliance in the manufacturing area.
• Develop and author necessarily supporting cGMP documentation that supports all manufacturing processes and operations, including but not limited to: Equipment Use Logs, Standard Operating Procedures (SOPs), Batch Production Records, Receiving Inspections, Deviation Reports.
• Troubleshoot process and/or product failures and investigate deviation. Drive CAPA investigations and implementation of actions working closely with the Quality Assurance.
• Communicate with other departments and cross functional teams to ensure for successful execution of operations for cGMP manufacturing and ensure that equipment and materials are available for production runs.
• Prepare and present technical data and processing information to clients, as necessary.
• Oversee and coordinate teams to meet project expectations related to timelines, budget, and quality.
• Mentor new employees and interns.

Process Development and Manufacturing Associate III: In addition to the responsibilities above, appointments at this level will…

This role will have the following responsibilities including but not limited to the following:

Significant independent contribution to:

• Tech-transfer of (E. coli protein) processes from client to development to manufacturing.
• Scale-up of multiple (protein) manufacturing processes for the cGMP suites.
• Capital, facility, and equipment upgrades and projects.
• Identify and/or confirm required materials for manufacturing processes.
• Independently support manufacturing activities for multiple unit operations, including E.coli fermentations, cell lysis and inclusion body preparation, purification by liquid chromatography and alternate methods, chemical and pressure refolding as well as formulation/development by tangential flow filtration. Includes the operation of Sartorius Biostat Fermenters (5 – 50 L scale), Sartorius TFF systems (Slice and Sartoflow).
• Lead analytical assay development; HPLC/UPLC, DSL, and gel electrophoresis.
• Author master batch records, production, and tech transfer reports.
• Mentor teams to meet project expectations related to timelines, budget, and quality.
• Provide exceptional communication and customer service to users of the facility.
• Prepare and present technical data and processing information to clients, as necessary.
• Work in a professional and collaborative manner with coworkers and prospective users.

Why Join Us:

The opportunity offered by the Gates Biomanufacturing Facility (GBF) is one of a kind. They blend the best of a large research organization of over 40,000 employees strong, with the family atmosphere of working with a team of 50+ highly dedicated people, operating on a top tier research campus – the University of Colorado – Anschutz Medical Campus.

The GBF and its partners on the CU Anschutz Medical Campus are delivering lifesaving therapies and working to develop more every day. They are only limited by their resources and need you to make their journey a success!

In addition to the amazing benefits offered, a few links are included below, identifying some of the exciting life sciences the GBF is delivering to patients.

Press Release:

GBF / CU Anschutz Video’s

The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, and holidays and more. To see what benefits are available, please visit:

Diversity and Equity:

The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty, and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ+ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

Qualifications:

Minimum Qualifications:

Process Development and Manufacturing Associate I:

• A bachelor’s degree in Biochemistry, Biology Bioengineering, Chemical Engineering, Chemistry or equivalent or a directly related field from an accredited institution.
  • Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year-for-year basis.
• At least one year of laboratory or manufacturing experience.

Applicants must meet minimum qualifications at the time of hire.

Process Development and Manufacturing Associate II:

• A Bachelor’s Degree (in Biochemistry, Bioengineering, Chemical Engineering, Chemistry, Biology).
  • Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year-for-year basis.
• 2+ years of GMP manufacturing experience in FDA-regulated setting.

Applicants must meet minimum qualifications at the time of hire.

Process Development and Manufacturing Associate III:

• A Bachelor’s Degree (in Biology, Bioengineering, Chemical Engineering, or a relevant field).
  • Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year-for-year basis.
• Three plus (3+) years of protein-related manufacturing or process engineering experience.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

Process Development and Manufacturing Associate I:

• Experience with biologics-based manufacturing process.
• Experience with inclusion body based solubilization, refolding, and purification techniques.
• Experience working in a cGMP manufacturing setting intended for human use, including work in ISO Class 7 and 8 rooms and ISO Class 5 biosafety cabinets.
• Experience operating and maintaining processing equipment.

Process Development and Manufacturing Associate II:

• Experience with biologics-based manufacturing process.
• Experience with authoring Standard Operating Procedures (SOPs), Batch Production Records, Raw Material Specifications, Deviation Reports.
• Experience with inclusion body based solubilization, refolding, and purification techniques.
• Experience working in a cGMP manufacturing setting intended for human use, including work in ISO Class 7 and 8 rooms and ISO Class 5 biosafety cabinets.
• Experience operating and maintaining processing equipment.

Process Development and Manufacturing Associate III:

• A Master’s Degree (in Biochemistry, Bioengineering, Chemical Engineering, Chemistry, Biology).
• Experience with E. coli based protein process development, including fermentation, refolding, chromatography, tangential flow filtration.

Conditions of Employment (All Levels):

This position may require weekend work and work outside of normal work hours to accommodate the completion of release testing or other critical processes which cross shifts. While not typical, this irregularity of work hours should be expected.

Competencies/Knowledge, Skills & Abilities:

• Excellent knowledge of GDP, GLP and/or GMP
• Ability to communicate effectively, both in writing and orally.
• Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
• Outstanding customer service skills.
• Demonstrated commitment and leadership ability to advance diversity and inclusion.
• Capable of working as an individual or in a team setting.
• Motivated self-starter capable of operating in a start-up environment.

How to Apply:

For full consideration, please submit the following document(s):

Questions should be directed to: Donna Parker at Donna.3.Parker@CUAnschutz.edu

Screening of Applications Begins:

Immediately and continues until the position is filled.

Anticipated Pay Range:

The starting hiring range for this position has been established as:

Research Services Intermediate Professional – Process Development and Manufacturing Associate I: $52,499-61,800

Research Services Senior Professional – Process Development and Manufacturing Associate II: $67,126-$77,324

Research Services Principal Professional Process Development and Manufacturing Associate III: $78,603 - $93,109

The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty and training.

The above hiring range represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

This position is not eligible for overtime compensation.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Total Compensation Calculator:

ADA Statement:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@ucdenver.edu.

Background Check Statement:

The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students, and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

Vaccination Statement:

The University of Colorado has a requirement for COVID-19 vaccinations and full completion thereof by 9/1/21 or upon start date. Information regarding this requirement, and exemptions can be found at:

Unit-Specific Exemptions:

• Anschutz Campus – Accommodations may be granted for medical or religious reasons.

The University of Colorado seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty, and staff of diverse backgrounds.