Downstream Process Development Scientist I

Location: Oklahoma City, OK
Department: Process Development
Job Type: Full-Time

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.