Biologics Process Development and Manufacturing Associate II & III (Open Rank)

University of Colorado Anschutz Medical Campus

Department:Gates Institute Biomanufacturing Facility

Job Title: Biologics Process Development and Manufacturing Associate II & III (Open Rank)

Position #: Requisition #:37357

Job Summary:

This position is a full-time Senior thru Principal Professional-level (open rank) position at the Gates Biomanufacturing Facility located on the Anschutz Medical Campus and serves on the Biologics team. This position will be responsible for supporting manufacturing 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.

Key Responsibilities:

Process Development and Manufacturing Associate II:

• 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.
• Draft and edit Batch Records Bill of Materials SOP Forms for Process Development and cGMP manufacturing documentation.
• Document Process development activities following Good Documentation Practices (GDP) 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.
• 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.
• Communicate with other departments and cross functional teams to ensure successful execution of operations for cGMP manufacturing and ensure that equipment and materials are available for production runs.
• Prepare and present technical data and process information to clients as necessary.

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:

• 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.
• Coordinates resources and executes tech transfer and scale-up plans with technical leads and/or project managers.
• Troubleshoot process and/or product failures and investigate deviation. Drive CAPA investigations and implementation of actions working closely with the Quality Assurance.
• Oversee and coordinate teams to meet project expectations related to timelines budget and quality.
• Mentor new employees and interns.

Work Location:

Onsite this role is expected to work onsite full-time and is located in Aurora CO.

Why Join Us:

The opportunity offered by the Gates Institute is one of a kind. We blend the best of a large research organization of over 40000 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 Gates Institute and its partners on the CU Anschutz Medical Campus are delivering lifesaving therapies and working to develop more every day. We are only limited by our resources and need you to make our journey a success!

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

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

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: work for the University

We haveAMAZINGbenefits and offerexceptional amounts of holiday vacation and sick leave! The University of Colorado offers an excellent benefits package including:

• Medical: Multiple plan options
• Dental: Multiple plan options
• Additional Insurance: Disability Life Vision
• Retirement 401(a) Plan: Employer contributes 10% of your gross pay
• Paid Time Off: Accruals over the year
• Vacation Days: 22/year (maximum accrual 352 hours)
• Sick Days: 15/year (unlimited maximum accrual)
• Holiday Days: 10/year
• Tuition Benefit: Employees have access to this benefit on all CU campuses
• ECO Pass: Reduced rate RTD Bus and light rail service

There are many additional perks & programs with the CU Advantage.

Qualifications:

Minimum Qualifications:

Process Development and Manufacturing Associate II (Senior Professional):

• A Bachelors Degree (in Biochemistry Bioengineering Chemical Engineering Chemistry Biology). Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelors 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 (Principal Professional):

• A Bachelors 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 bachelors degree on a year-for-year basis.
• 3 years of protein-related manufacturing or process engineering experience.

Applicants must meet minimum qualifications at the time of hire.

Conditions of Employment:

• This is a full-time onsite position which may require weekend work and work outside of normal work hours to accommodate the completion of time sensitive critical processes which cross shifts. While not typical this irregularity of work hours should be expected.
• Must be willing and able to lift up to 50 lbs of lab equipment with assistance.

Preferred Qualifications:

Process Development and Manufacturing Associate II (Senior Professional):

• Three plus (3) years of protein-related manufacturing or process engineering experience.
• 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 III (Principal Professional

• A masters degree (in Biology Biochemistry Bioengineering Chemical Engineering Chemistry).
• Five plus (5) years of protein expression and purification process development.
• At least one year of cGMP manufacturing experience.
• Experience in planning biologics-based manufacturing operations.
• 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.

Competencies/Knowledge Skills & Abilities:

• 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.
• Capable of working as an individual or in a team setting.
• Motivated self-starter capable of operating in a start-up environment.
• Significant lab process development and/or manufacturing experience.

How to Apply:

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

1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position

2. Curriculum vitae / Resume

3. Three to five professional references including name address phone number (mobile number if appropriate) and email address

Questions should be directed to: Dash Batt

Screening of Applications Begins:

Immediately and continues until position is filled. For best consideration apply by August 6 2025.

Anticipated Pay Range:

The starting salary range (or hiring range) has been established as:

Senior Professional: $56003 - $71236

Principal Professional: $72313 - $91983.

The above salary range (or hiring range) represents the Universitys good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation depending on the level.

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: Employment Opportunity Statement:

CU is an Equal Opportunity Employer and complies with all applicable federal state and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity and we encourage individuals from all backgrounds to apply including protected veterans and individuals with disabilities.

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 .

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:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and othervaccine preventable diseases. If you work visit or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work visit or volunteer respectively. In addition if you work in certain research areas or perform certain safety sensitive job duties you must enroll in theoccupational health medical surveillance program.