Downstream Process Development Scientist I

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.