Manufacturing Bioprocess Associate I

Job Title: Manufacturing Bioprocess Associate I

Job Description

The Manufacturing Bioprocess Associate I is an entry-level position responsible for executing cGMP manufacturing operations that support drug substance production in a CDMO facility. In this hands-on role, you will perform upstream or downstream bioprocessing activities under supervision while building a strong foundation in GMP principles, documentation practices, and bioprocessing systems. You will contribute directly to reliable, high-quality biologics manufacturing in a fast-growing, innovation-focused organization.

Responsibilities

• Execute cGMP manufacturing operations for biologics drug substance in either upstream or downstream processing areas under appropriate supervision.
• Complete all required documentation in batch records, logbooks, and electronic systems, including SAP entries, in full compliance with cGMP and data integrity requirements.
• Follow standard operating procedures (SOPs) and master batch records (MBRs/EBRs) to set up, operate, and monitor equipment such as pH and conductivity meters, osmometers, pumps, tube welders, and related bioprocessing systems.
• Support manufacturing readiness activities by requesting, transferring, staging, and organizing materials, including participation in kanban inventory management processes.
• Prepare process solutions such as media and buffers required for production runs, ensuring accurate measurements, mixing, and documentation.
• Maintain cleanroom standards by strictly adhering to gowning procedures, aseptic techniques, and cleanroom behavior expectations.
• Assist with equipment preparation, line clearance, and changeover activities between production runs to ensure readiness and compliance.
• Support routine cleaning, sanitization, and 5S activities within manufacturing suites to maintain a safe, organized, and inspection-ready environment.
• Promptly escalate deviations, atypical events, or equipment issues to staff and support related quality investigations as needed.
• Actively participate in training activities, maintain compliance with the individual training plan, and continually develop bioprocessing and GMP knowledge.
• Identify and propose process improvements to enhance safety, quality, efficiency, and consistency in manufacturing operations.
• Collaborate effectively within a team-oriented environment, communicating clearly with colleagues in manufacturing, quality, and support functions.
• Perform physical tasks associated with manufacturing operations, including moving materials, climbing, reaching, operating hand tools, and using production and laboratory equipment.
• Adhere to all safety guidelines, procedures, and SOPs, taking shared responsibility for maintaining a safe work environment.
• Carry out additional duties and responsibilities as assigned to support evolving business and production needs.

Essential Skills

• 0–2 years of biologics manufacturing experience in upstream or downstream processing.
• Working knowledge of GMP documentation practices, including accurate and compliant completion of batch records and logbooks.
• Understanding of cleanroom behavior, aseptic techniques, and gowning procedures.
• Ability to follow SOPs, MBRs, and EBRs to operate bioprocessing equipment such as pH and conductivity meters, osmometers, pumps, tube welders, and related systems.
• Familiarity with cGMP principles and their application in biopharmaceutical or pharmaceutical manufacturing environments.
• Ability to work effectively in a team-oriented environment and communicate clearly with peers and supervisors.
• Good eye/hand coordination and visual acuity to safely and accurately perform laboratory and manufacturing tasks.
• Proficiency in using keyboards, computers, and phones to support electronic documentation and communication.
• Physical ability to move, climb, reach, and operate hand tools as required in a manufacturing setting.
• Commitment to regular and predictable attendance and flexibility to work irregular hours, including nights, weekends, and holidays as needed.

Additional Skills & Qualifications

• Associate or bachelor’s degree in a science-related field or equivalent relevant experience.
• Experience or exposure to biologics, bioprocessing, and production in biopharmaceutical, pharmaceutical, or biotechnology environments.
• Familiarity with downstream processing techniques such as chromatography and filtration, including TFF (tangential flow filtration).
• Understanding of quality management concepts, including deviations, CAPA, and change control processes.
• Experience with or exposure to MSAT (Manufacturing Science and Technology) activities is beneficial.
• Knowledge of equipment validation principles and practices in a GMP environment.
• Interest in and aptitude for process improvement, with a willingness to propose and support implementation of enhancements.
• Ability to maintain sensory awareness (smell and sound) to monitor equipment and environmental conditions.
• Willingness to travel approximately 5% to 10% of the time, which may include international travel.

Work Environment

This is a site-based role primarily located on the manufacturing floor and in laboratory environments within a cGMP production facility. The position supports a 24/7 manufacturing operation and may require a fluid work schedule, including weekends, nights, holidays, and schedule changes based on business needs. During routine production, you can expect to spend at least 75% of your time on the manufacturing floor, working directly with bioprocessing equipment and process areas. The work environment includes cleanroom suites where strict gowning procedures, aseptic techniques, and cleanroom behavior must be followed at all times. You will work with biologics manufacturing technologies such as chromatography and filtration systems, TFF equipment, pumps, pH and conductivity meters, osmometers, tube welders, and electronic systems including SAP and other GMP documentation platforms. The facility may include areas with extreme temperatures, high noise levels, restricted laboratory access, and exposure to dust, gas, fumes, steam, or chemicals, with appropriate safety controls and PPE provided. The organizational culture emphasizes scientific innovation, safety, collaboration, and continuous improvement, with a strong focus on supporting clients in pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries worldwide.

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

The pay range for this position is $25.00 - $30.00/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 7, 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.