Scientist - Downstream MSAT

The Downstream MSAT Scientist supports drug substance intermediate and drug substance manufacturing within the Manufacturing Sciences and Technologies (MSAT) organization. This role focuses on downstream process development and support, including robustness studies, investigations, continued process verification, technology transfer, and second-generation process development for monoclonal antibody (mAb) programs. You will work primarily in a non-GMP laboratory environment, ensuring all activities comply with applicable regulations, quality standards, and internal policies, while contributing directly to process launches and commercial support for an innovative oncology pipeline.

Responsibilities

• Design and execute laboratory experiments using established scientific methods to support research, development, and manufacturing objectives for downstream processes.
• Independently plan experimental studies, including defining scope and approach, and manage execution to meet project timelines.
• Analyze experimental results, draw scientifically sound conclusions, and present findings and recommendations to project teams and technical stakeholders.
• Lead downstream model activities at laboratory and pilot scale, including process development, optimization, and troubleshooting.
• Prepare and analyze samples using appropriate biochemistry, purification, and filtration laboratory instrumentation and techniques.
• Perform chromatography operations and column packing, with preferred use of Cytiva AKTA systems and associated resins.
• Execute normal flow filtration and tangential flow filtration operations for protein purification, especially monoclonal antibodies.
• Analyze process and analytical data using visualization and statistical tools to inform hypotheses, guide experimental design, and support project-level decisions.
• Use statistical analysis and experimental design software to plan studies and interpret data for process characterization and robustness assessments.
• Maintain accurate, complete, and compliant documentation of experimental procedures, data, and observations in accordance with ALCOA principles using electronic laboratory notebooks and other digital systems.
• Collaborate cross-functionally with scientists, engineers, and leadership to troubleshoot process issues, interpret experimental outcomes, and support technology transfer to pilot and commercial facilities.
• Support scale-up and technology transfer activities to ensure smooth implementation of downstream processes on the manufacturing floor.
• Contribute to MSAT and network-wide initiatives that promote operational excellence and scientific advancement in downstream processing.
• Communicate progress, risks, and technical insights clearly through written reports, presentations, and meetings with multidisciplinary teams.

• Bachelor’s degree in Microbiology, Biochemistry, Biochemical Engineering, Pharmaceutical Sciences, or a closely related scientific discipline.
• Approximately 2–5 years of relevant industry experience in downstream processing, MSAT, or closely related biopharmaceutical process development work.
• Hands-on experience with biochemistry, purification, and filtration laboratory techniques and instrumentation.
• Ability to safely perform laboratory tasks such as weighing solids, preparing solutions, and handling reagent additions.
• Experience with chromatography operations and column packing, preferably using Cytiva AKTA systems and associated resins.
• Experience with normal flow filtration and tangential flow filtration of proteins, particularly monoclonal antibodies.
• Proficiency in analyzing process and analytical data using data visualization and statistical tools.
• Experience with statistical analysis and experimental design software packages for designing and evaluating experiments.
• Strong attention to detail with the ability to follow, execute, and adapt scientific protocols as needed.
• Demonstrated strength in data interpretation, technical documentation, and preparation of clear scientific reports.
• Effective written and verbal communication skills for conveying complex technical information to diverse audiences.
• Proven ability to work collaboratively in multidisciplinary teams, including scientists, engineers, and operational staff.
• Proficiency with Microsoft Office tools, including Word, Excel, PowerPoint, Teams, and SharePoint.

• Experience supporting scale-up and technology transfer of downstream processes to pilot and commercial-scale manufacturing facilities.
• Familiarity with downstream process development for monoclonal antibodies and other protein therapeutics.
• Understanding of continued process verification, process robustness studies, and investigations within a biopharmaceutical context.
• Exposure to non-GMP development environments with awareness of applicable regulations, quality standards, and internal policies.
• Interest in contributing to oncology pipeline launches and next-generation process development initiatives.
• Motivation to grow within an MSAT organization and to work at the forefront of innovative processes and technologies.

You will work primarily in a pharmaceutical manufacturing support setting, spending most of your time at the bench in the MSAT laboratory conducting non-GMP experiments, with regular visits to production areas to support and observe technology transfer and scale-up activities. The environment combines modern lab facilities for downstream process development with access to pilot and commercial manufacturing equipment on the production floor. You will partner closely with other scientists, engineers, and site leadership in a collaborative, cross-functional culture that emphasizes scientific rigor, operational excellence, and knowledge sharing. The site operates as a monoclonal antibody center of excellence, providing exposure to cutting-edge processes, advanced purification technologies, and a strong oncology-focused pipeline. The role is part of a structured multi-year program, offering the opportunity to learn from experienced experts, contribute to impactful patient-focused therapies, and be considered for longer-term opportunities during the assignment.

Job Type & Location

This is a Contract position based out of Apex, NC.

The pay range for this position is $30.00 - $50.00/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 Apex,NC.

This position is anticipated to close on Apr 30, 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.

Salary : $30 - $50