Downstream Process Development Scientist I / Wheeler Bio

Plainsvc; Oklahoma City (OK); On-site; USD 85,000 - 115,000; Full time

Job summary

Plainsvc seeks an experienced Biotech Process Development Scientist I to advance downstream bioprocesses from laboratory to pilot scale for biologics production. You will lead purification steps, viral clearance studies, and tech transfer to manufacturing while ensuring GMP/GLP compliance and regulatory readiness.

The role requires strong data analysis skills, proficiency with AKTA/UNICORN, and collaboration across Upstream, Analytical Development, QA, MSAT, and Manufacturing teams.

Qualifications

• Bachelor’s degree in Biological Sciences, Chemical Engineering, or Biotechnology; advanced degrees are a plus.
• 4–6 years of bioprocess development experience in biotech/pharma.
• Hands-on purification, viral clearance, and process characterization experience.
• Experience scaling from lab to pilot and tech transfer to manufacturing.
• Proficiency with PAT and downstream purification equipment.
• Strong data analysis and use of Excel, JMP, GraphPad.
• Excellent communication and teamwork, with ability to work independently.

Responsibilities

• Design, optimize, and execute experiments to advance downstream bioprocesses from lab to pilot scale.
• Lead tech transfer and provide technical guidance for manufacturing.
• Manage viral clearance studies and optimize yield, purity, and product quality attributes.
• Collaborate with Upstream, Analytical Development, QA, MSAT, and Manufacturing.
• Prepare protocols, reports, SOPs, and regulatory filings and ensure GMP/GLP compliance.

Skills

Bioprocess development

Data analysis

Cross-functional collaboration

Troubleshooting

Mentoring

Education

Bachelor's degree in Biological Sciences, Chemical Engineering, Biotechnology

Tools

AKTA purification systems

UNICORN software

Excel

JMP

GraphPad

Job description

Position Overview

We are seeking an experienced and highly motivated Biotech Process Development Scientist I to join our innovative team. This role will focus on advanced process development, optimization, and scale‑up of bioprocesses for the production of biologics and therapeutic products. As a Downstream Process Development Scientist I, you will work independently and as part of a multidisciplinary team to drive the development of robust, scalable processes while collaborating with other departments to ensure project success.

Key Responsibilities

• Independently design, optimize, and execute experiments to advance bioprocesses for downstream operations, including monoclonal antibodies, Fc‑fusion proteins, bispecific antibodies, and cytokines.
• Lead the development and scale‑up of bioprocesses from laboratory‑scale through to pilot‑scale and provide technical expertise for technology transfer to commercial manufacturing for clarification, chromatography (including affinity, ion exchange, hydrophobic interaction and mixed‑mode), viral inactivation and viral filtration, ultra‑filtration/diafiltration and filtration unit operations and process steps.
• Manage and execute viral clearance studies.
• Assist in the optimization of downstream bioprocess parameters for yield, purity, and product quality attributes, collaborating with upstream, analytical and formulation teams.
• Troubleshoot and resolve complex technical challenges by analyzing process data, performing root cause analysis, and implementing corrective actions.
• Collaborate with cross‑functional teams, including Upstream and Analytical Development, Quality Assurance, MSAT, and Manufacturing to ensure the successful progression of projects.
• Lead the preparation and review of detailed technical documentation, including experimental protocols, reports, standard operating procedures (SOPs), and regulatory filings.
• Monitor and ensure compliance with industry regulations, including Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and FDA guidelines throughout the process development lifecycle.
• Provide mentorship and guidance to junior team members, helping to develop their skills and knowledge in bioprocess development.
• Plan and execute experiments in a timely manner, ensuring all milestones and timelines are met.
• Prepare presentations for internal stakeholders and regulatory authorities to communicate process development progress, challenges, and solutions.
• Contribute to the preparation of process development budgets and timelines, and track project deliverables against established goals.

Qualifications

Bachelor’s degree in Biological Sciences, Chemical Engineering, Biotechnology, or a related field. A Master’s degree or Ph.D. is a plus.

Minimum of 4-6 years of experience in bioprocess development, preferably within a biotech, pharmaceutical, or biologics manufacturing environment.

Strong hands‑on experience with purification techniques, viral clearance, and process characterization.

Expertise in process development strategies for scaling up from laboratory to pilot scale and facilitating technology transfer to manufacturing.

Proficiency with process analytical technologies (PAT), and experience with downstream purification equipment, and chromatography techniques.

Strong understanding of regulatory requirements, including GMP, GLP, FDA, and ICH guidelines.

Experience in AKTA purification systems and UNICORN software and liquid handling platforms is preferred.

Proficiency in data analysis and process modeling using software tools such as Excel, JMP, GraphPad, or similar platforms.

Strong problem‑solving, troubleshooting, and critical‑thinking skills with the ability to manage multiple projects simultaneously.

Excellent written and verbal communication skills, with the ability to convey complex technical concepts to both technical and non‑technical stakeholders.

Proven ability to work effectively both independently and in a team‑oriented, collaborative environment.

Physical Requirements

• Ability to perform lab‑based tasks, including standing for long periods, working with various laboratory equipment, and handling biological samples.
• Must be able to lift and carry equipment, reagents, and materials weighing up to 25 pounds.

Working Conditions

This position requires flexibility in working hours, including potential shift work, weekends, and on‑call duties as necessary.

Work involves the handling of biological materials.