Senior Manufacturing Bioprocess Associate (Upstream)
Actalent
Posted Thursday, April 30, 2026
Posting ID: JP-005997162
Job Title: Lead Manufacturing Bioprocess Associate (Upstream)
Job Description
The Lead Manufacturing Bioprocess Associate (Upstream) performs complex biologics manufacturing activities with minimal supervision, focusing primarily on upstream operations while supporting related downstream activities as needed. This role is responsible for executing seed train and bioreactor operations, preparing media and buffers, operating critical process equipment, and ensuring all activities comply with cGMP and regulatory requirements. The position plays a key role in new product introductions, technology transfer, and continuous improvement initiatives within a dynamic, growth-oriented biopharmaceutical manufacturing environment.
Responsibilities
- Execute upstream unit operations, including seed train and bioreactor processes, according to batch requirements and established procedures.
- Support downstream unit operations such as chromatography, tangential flow filtration (TFF), and filtration as needed to ensure end-to-end process continuity.
- Prepare and test media and buffer solutions in accordance with SOPs and batch instructions, including pH and conductivity adjustments and related in-process checks.
- Operate, monitor, and maintain glass wash and autoclave systems to ensure timely sterilization and availability of process components and equipment.
- Assist with system setup, including tubing configurations, equipment assembly, and filter integrity testing prior to use.
- Perform routine and deep cleaning, sanitization, and line clearance of equipment, production suites, and cleanroom areas to maintain a compliant environment.
- Execute Master Batch Records (MBRs) under cGMP, ensuring accurate, complete, and timely documentation of all operations in alignment with SOPs and batch records.
- Ensure strict adherence to cGMP standards, FDA/EMA regulatory requirements, and internal SOPs throughout all manufacturing activities.
- Maintain robust data integrity and documentation practices, including batch records, logbooks, change controls, and cleaning records.
- Support deviation investigations by providing detailed operational input, participating in root cause analysis, and contributing to the development and implementation of effective CAPAs.
- Ensure cGMP compliance of all batch records, logbooks, and cleaning documentation, and support quality documentation activities as required.
- Contribute to the development and execution of CAPAs and other quality system improvements to enhance process robustness and compliance.
- Support 24/7 manufacturing operations as needed, including off-shift, weekend, and holiday coverage to meet production schedules.
- Serve as manufacturing support for new product introductions, collaborating closely with MSAT and Process Development teams during technology transfer.
- Ensure facility and equipment readiness for new processes, including supporting equipment commissioning, qualification, and documentation updates.
- Assist in the preparation and review of SOPs and MBRs for new or modified processes, and support personnel training to ensure operational readiness.
- Support execution of process performance qualification (PPQ) batches and readiness activities associated with commercial launch.
- Maintain 5S standards within production areas to promote a safe, organized, and efficient work environment.
- Propose and implement process improvements to enhance productivity, reduce variability, and strengthen operational excellence.
- Perform other related duties as assigned to support manufacturing, quality, and operational objectives.
Essential Skills
- 2–4 years of biologics manufacturing experience in upstream and/or downstream operations.
- Associate or Bachelor degree in a science-related field, or equivalent relevant experience.
- Strong working knowledge of cGMP principles and GMP documentation practices.
- Hands-on experience with upstream biologics operations, including cell culture, fermentation, seed train, and bioreactor processes.
- Understanding of downstream biologics purification operations such as chromatography, filtration, and TFF.
- Experience preparing media and buffer solutions, including pH and conductivity adjustments and related testing.
- Familiarity with cleanroom behavior, aseptic techniques, and gowning procedures.
- Experience with new facility startup and equipment commissioning and qualification activities.
- Ability to execute Master Batch Records accurately and consistently under cGMP conditions.
- Experience working with deviations, CAPA, change control, and quality management systems.
- Knowledge of equipment validation concepts and requirements in a regulated environment.
- Experience in biopharmaceutical, pharmaceutical, biotechnology, or bioprocess production settings.
- Demonstrated ability to follow SOPs, safety guidelines, and standardized work practices.
- Good eye/hand coordination, visual acuity, and proficiency in using keyboards, computers, and phones.
- Ability to maintain a stationary position, move and traverse the facility, climb, reach, operate hand tools, and perform repetitive movements required for manufacturing tasks.
- Commitment to regular and predictable attendance and flexibility to work irregular hours to support 24/7 operations.
Additional Skills & Qualifications
- Experience operating in a contract development and manufacturing organization (CDMO) or supporting client-sponsored manufacturing projects.
- Deep understanding of biologics manufacturing unit operations across upstream (cell culture/fermentation) and downstream (purification) processes.
- Experience with MSAT collaboration and technology transfer activities for new product introductions.
- Exposure to filtration, chromatography, and related bioprocess equipment and systems.
- Experience implementing or supporting process improvement and operational excellence initiatives, including 5S.
- Familiarity with bioprocess environments such as biotech, biopharmaceutical, and pharmaceutical manufacturing.
- Ability to contribute effectively to deviation investigations, root cause analysis, and CAPA development.
- Comfort working in a fast-growing, innovation-focused organization with global clients in pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemicals.
- Willingness to travel 5% to 10% of the time, including occasional international travel.
Work Environment
This is a site-based role primarily located on the manufacturing floor, in laboratory environments, and in materials warehouse areas. The position supports a fluid schedule aligned with 24/7 biologics manufacturing operations, which may include weekends, nights, and holidays. During routine production, the role requires being present on the manufacturing floor for a significant portion of the time to monitor processes and support operations. The work environment includes cleanrooms and controlled areas that require adherence to gowning procedures, aseptic techniques, and strict cGMP and safety standards. Conditions may involve exposure to extreme temperatures, high noise levels, restricted laboratory access areas, and the presence of dust, gas, fumes, steam, or chemicals. The role involves regular use of computers, phones, and process equipment, along with physical activities such as standing for extended periods, walking throughout the facility, climbing, reaching, operating hand tools, and performing repetitive motions. The organization promotes a culture driven by passionate scientists, strong safety practices, and shared responsibility for following safety guidelines, procedures, and SOPs, with a focus on innovation, collaboration, and supporting global clients in bringing products to market efficiently and cost-effectively.
Job Type & LocationThis is a Contract to Hire position based out of Baltimore, MD.
Pay and BenefitsThe 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.
Application DeadlineThis 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.
Contact Information
Recruiter: Alexis Atkinson
Phone: +14105678051
Email: alatkinson@actalentservices.com
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