Bioprocessing Associate II, Downstream Associate

Job Description

Job Description

Job Title: Bioprocessing Associate II, Downstream Associate

Job Description

The Bioprocessing Associate II, Downstream Associate supports routine GMP Manufacturing Operations in a newly constructed early-stage cell and gene therapy facility in Louisville, CO. The role focuses primarily on solution preparation and downstream purification, including chromatography and various filtration methods, while also supporting other manufacturing functions as needed. You will help onboard and qualify manufacturing equipment, execute batch records, and contribute to the implementation of facility quality systems to enable successful production of phase 1 lentiviral drug products. This position works closely with process engineers, Process Sciences, facilities, warehouse and supply chain, EHS, Quality Assurance, and Quality Control in a highly collaborative, matrixed team environment dedicated to advancing novel immunotherapy treatments for solid tumors.

Responsibilities

• Execute compliant and technically sound downstream purification programs and systems in support of GMP manufacturing operations.
• Perform chromatography, tangential flow filtration (TFF), and other filtration operations, ensuring a strong understanding of the methods and underlying theory.
• Support solution preparation activities, including buffer and media preparation, weighing and dispensing materials, and preparing transfer kits and components.
• Participate in the internal technology transfer of novel cell and gene therapy manufacturing processes at various scales from Process Sciences to Manufacturing.
• Observe, participate in, and perform initial internal technology transfer runs, ensuring processes are accurately translated into routine manufacturing operations.
• Perform activities related to the introduction of new raw materials, including drafting, reviewing, and supporting approval of material specifications.
• Conduct equipment cleaning and sanitization in accordance with routine maintenance schedules, pre- and post-process requirements, and initial facility commissioning needs.
• Adhere strictly to Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), and good documentation practices in all manufacturing activities.
• Perform aseptic manufacture of lentiviral products in a classified cleanroom environment (ISO 5, ISO 7, ISO 8, and ISO 9) while fully gowned.
• Maintain inventory and perform stocking activities for gowning supplies, cleaning materials, and consumables to ensure continuous support of manufacturing operations.
• Carry out material management activities, including kitting and staging Bill of Materials (BOM) items for production runs.
• Revise and update manufacturing documents, including Master Batch Records (MBRs), Standard Production Records (SPRs), and provisional SOPs (pSOPs).
• Assist in the onboarding, qualification, and ongoing management of manufacturing equipment used in downstream and solution preparation operations.
• Support the implementation and continuous improvement of facility quality systems related to manufacturing operations.
• Collaborate closely with internal stakeholders across process engineering, Process Sciences, facilities, warehouse and supply chain, EHS, Quality Assurance, and Quality Control.
• Contribute to a safe working environment by following EHS guidelines and handling chemicals and biological materials in accordance with established procedures.
• Work primarily on hands-on manufacturing operations (approximately 90% of the time), with 5–10% of time dedicated to SOP work, document revisions, and related tasks.
• Perform other duties as needed to support manufacturing operations and organizational goals, including occasional night and weekend work aligned with manufacturing schedules.

Essential Skills

• Bachelor’s degree in biotechnology, biochemistry, or a related life-sciences field with at least 2 years of cGMP manufacturing experience in the pharmaceutical and/or biologics field; OR an Associate’s degree in a related biotechnology or life-sciences field with at least 4 years of cGMP manufacturing experience in the pharmaceutical and/or biologics field; OR an equivalent combination of education and experience.
• Demonstrated cGMP or cGMP-like manufacturing experience within the pharmaceutical and/or biologics industry.
• Hands-on experience with downstream manufacturing operations such as protein purification, chromatography, and filtration.
• Experience with solution preparation, including buffers and media, and weighing and dispensing of components.
• Ability to perform aseptic manufacturing and work confidently in an aseptic cleanroom environment (ISO 5–9).
• Understanding of bioprocessing principles, including protein purification and downstream bioprocess operations.
• Ability to gown aseptically and work fully gowned in a cleanroom for extended periods of time.
• Comfort working around laboratories and manufacturing areas, including extensive use of laboratory equipment and handling of chemicals and biological materials.
• Ability to regularly lift 10–20 lbs and periodically lift up to 50 lbs as part of routine manufacturing activities.
• Ability to work evenings, nights, weekends, and holidays as required to support manufacturing runs.
• Strong organization and communication skills, with the ability to work independently and as part of a multi-disciplinary, matrixed team.
• Proficiency with computer applications such as word processing, spreadsheets, and web-based systems.
• Demonstrated ability to follow SOPs, maintain cGMP compliance, and apply good documentation practices.

Additional Skills & Qualifications

• Prior downstream purification or solution preparation experience in a GMP environment is strongly preferred.
• Prior GMP manufacturing experience beyond minimum requirements is preferred.
• Prior experience receiving or executing technology transfer from development or Process Sciences into Manufacturing is preferred.
• Experience with tangential flow filtration (TFF), including single-use technologies such as ready-to-use or single-use systems.
• Experience with chromatography systems (such as KPMI or similar platforms) and, ideally, large-scale stainless-steel processing equipment.
• Biologics manufacturing experience, particularly with lentiviral or other viral vector products, is advantageous.
• Demonstrated experience working on results-oriented teams where collaboration and individual contribution were critical to project success.
• Self-motivated mindset with the ability to prioritize tasks, manage time effectively, and adapt to changing priorities in a startup environment.
• Interest in career growth with potential pathways into material handling, laboratory roles, analytical development, manufacturing, or research roles.
• Openness to mentorship and career development through a structured mentor program that supports networking and exposure to various departments, roles, and jobs.

Work Environment

The environment is highly collaborative, innovative, and mission-driven, with a unified, joyful culture that keeps patients at the center of decision-making. You will work extensively in classified cleanrooms (ISO 5, 7, 8, and 9) and will be fully gowned for long periods of time, sometimes up to approximately four hours per day depending on the stage of the manufacturing run and business needs. Work involves frequent use of laboratory and manufacturing equipment, handling of chemicals and biological materials, and operation of downstream technologies such as chromatography systems, TFF systems (including single-use technologies), and large-scale stainless-steel equipment. Initial training follows a Monday–Friday schedule from 8:00 a.m. to 5:00 p.m. After training, you transition to a 4x10 schedule: either Monday through Thursday or Tuesday through Friday, typically 8:00 a.m. to 6:00 p.m., with the expectation of working evenings, nights, weekends, and holidays as required by manufacturing campaigns.

This is a Contract position based out of Louisville, CO.

The pay range for this position is $30.53 - $36.78/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Louisville,CO.

This position is anticipated to close on Jul 10, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.