Senior Manufacturing Bioprocess Associate (Downstream)

The Senior Manufacturing Bioprocess Associate (Downstream) plays a crucial role in executing complex biologics manufacturing activities with minimal supervision. This position supports both upstream and downstream operations, including buffer and media preparation, process equipment operation, system setup, and sterilization support.

Responsibilities

• Execute upstream (seed train, bioreactor) and downstream (chromatography, TFF) unit operations per batch requirements.
• Prepare and test media or buffer solutions following SOPs and batch instructions, including pH and conductivity adjustments.
• Operate and maintain glass wash and autoclave systems for sterilization and process component availability.
• Assist in system setup, tubing configurations, and filter integrity testing.
• Perform cleaning, sanitization, and line clearance of equipment and cleanroom areas.
• Execute Master Batch Records (MBR) under cGMP and document all operations clearly using SOPs and batch records.
• Ensure strict adherence to cGMP standards, FDA/EMA regulatory requirements, and internal SOPs.
• Support deviation investigations, root cause analysis, and implementation of effective CAPAs.
• Adhere to data integrity and robust documentation practices, including batch records and change controls.
• Serve as manufacturing support for new product introductions (NPI), working closely with MSAT and Process Development.
• Support execution of process performance qualification (PPQ) batches and readiness for commercial launch.
• Maintain 5S standards and propose and implement process improvements.
• Support 24/7 operations as needed, including off-shift or weekend coverage.

• 2-4 years of biologics manufacturing experience (upstream or downstream).
• Associate or Bachelor degree in a science-related field or equivalent relevant experience.
• Working knowledge of GMP documentation, cleanroom behavior, and aseptic techniques.
• Experience with new facility startup, equipment commissioning/qualification.
• Deep understanding of upstream (cell culture/fermentation) and downstream (purification) unit operations for biologics manufacturing.
• Prior experience supporting client-sponsored manufacturing or operating in a CDMO environment.

• Proficiency in using keyboards, computers, and phones.
• Good eye/hand coordination and visual acuity.
• Ability to perform repetitive movements and operate hand tools.
• Flexibility to work irregular hours and commit to regular and predictable attendance.
• Role may require 5% to 10% travel, including international travel.

The work environment involves a site-based role with a fluid schedule to support 24/7 manufacturing, including weekends, nights, and holidays. The role requires spending at least 75% of the time on the manufacturing floor. Physical demands include maintaining a stationary position, traversing the facility, climbing, reaching, and exposure to extreme temperatures, high noise, and restricted laboratory access. The environment may involve dust, gas, fumes, steam, or chemicals. The work is conducted on the manufacturing floor and in the lab.

Job Type & Location

This is a Contract to Hire position based out of Baltimore, MD.

The pay range for this position is $30.00 - $38.00/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 Baltimore,MD.

This position is anticipated to close on May 14, 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.