Senior Bioprocessing Associate

Bioprocessing Senior Associate, Drug Product

The Bioprocessing Senior Associate, Drug Product supports upstream manufacturing operations at a newly constructed early-stage cell and gene therapy GMP manufacturing facility in Louisville, CO. In this hands-on role, you execute GMP processes for large-scale viral vector production, contribute to day-to-day operations of the upstream processing team, and collaborate closely with cross-functional partners. You help advance novel cell and gene therapies aimed at targeting solid tumors, working within a unified, collaborative, and patient-focused culture. This role is fully onsite Monday through Friday and requires flexibility to work evenings, weekends, and holidays as business needs arise.

Responsibilities

• Perform aseptic manufacturing of lentiviral products in a cleanroom environment across ISO 5, ISO 7, ISO 8, and ISO 9 classifications.
• Execute upstream GMP manufacturing processes to produce viral vectors at large scale while maintaining high quality and compliance standards.
• Ensure continuous compliance with applicable regulatory requirements, current Good Manufacturing Practices (cGMP), and internal quality standards.
• Strictly adhere to Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP) in all manufacturing activities.
• Author, revise, and maintain processing SOPs, equipment SOPs, and batch records to reflect current practices and process improvements.
• Mentor and coach junior associates in the preparation and authorship of controlled documents and SOPs for Manufacturing Operations.
• Analyze process and production data and communicate results, trends, and recommendations to the upstream team.
• Actively participate in the receipt and implementation of internal technology transfers for novel cell and gene therapy manufacturing processes at various scales.
• Provide effective support for deviation investigations and out-of-specification events, collaborating with relevant stakeholders to identify root causes and corrective actions.
• Adhere to Occupational Health and Safety policies and participate in health and safety audits and risk assessments.
• Perform equipment cleaning and routine maintenance activities according to pre- and post-process requirements and scheduled maintenance events.
• Participate in and execute equipment, process, and system validation activities, including Environmental Monitoring Performance Qualification (EMPQ) and IQ/OQ of manufacturing equipment and systems.
• Maintain inventory levels and perform stocking activities for gowning supplies, cleaning materials, and consumables to ensure uninterrupted manufacturing operations.
• Perform and oversee material management activities related to the kitting of Bill of Materials (BOM) items for manufacturing runs.
• Support media and buffer preparation and perform aseptic filling activities as needed to enable upstream operations.
• Work effectively under pressure with a proactive, solutions-oriented approach to meet manufacturing timelines and operational goals.
• Collaborate in a cross-functional, matrixed environment to support new product introductions, inventory establishment, and process improvements.
• Carry out other related duties as assigned to support manufacturing operations and continuous improvement initiatives.

Essential Skills

• Bachelor’s degree in biotechnology, life sciences, or a related field.
• Minimum of 4 years of cGMP manufacturing experience in the pharmaceutical and/or biologics industry.
• Demonstrated experience working in aseptic environments and cleanrooms.
• Hands-on mammalian cell culture experience, including cell culture scale-up.
• Experience with aseptic manufacturing and aseptic technique.
• Practical experience with single-use bioreactors and bioreactor operations.
• Experience with harvest clarification methods such as depth filtration and centrifugation.
• Proven ability to create, review, and revise SOPs and batch process records.
• Strong understanding of GMP, Good Documentation Practices, and regulatory expectations in a manufacturing setting.
• Ability to work evenings, weekends, and holidays as needed to support manufacturing schedules.
• Strong time-management skills with the ability to prioritize and complete tasks effectively in a fast-paced environment.
• Demonstrated ability to work under pressure with a positive, solution-driven attitude.
• Ability to gown aseptically and work in cleanroom environments, including ISO 5, for extended periods.
• Ability to work around laboratories and manufacturing areas, handle chemicals and biological materials safely, and regularly lift 10–20 lbs and occasionally up to 50 lbs.
• Strong organization and communication skills with the ability to work independently and as part of a multidisciplinary, matrixed team.

Additional Skills & Qualifications

• Viral vector production experience, particularly with lentiviral products, is preferred.
• Experience with downstream manufacturing processes is beneficial.
• Leadership experience such as serving as a subject matter expert (SME) or qualified trainer is preferred.
• Prior experience receiving and implementing technology transfers is strongly preferred.
• Ability to troubleshoot issues of moderate scope independently and propose effective solutions.
• Ability to independently develop work plans and schedules to ensure timely completion of assignments and deliverables.
• Proven experience leading results-oriented teams where collaboration and contribution were critical to success.
• Proficiency with computer applications including word processing, spreadsheets, and web-based systems.
• Experience with Environmental Monitoring Performance Qualification (EMPQ) and environmental monitoring activities.
• Experience with IQ/OQ of manufacturing equipment and systems.
• Familiarity with data analysis and preparation of reports to support manufacturing decisions.
• Self-motivated mindset with a strong sense of ownership and accountability for work outcomes.
• Interest in working within an innovative, early-stage biotech environment focused on cell and gene therapies.

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

The pay range for this position is $36.08 - $44.57/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 May 6, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.