Downstream Process Development Associate 3

We are seeking an experienced and highly motivated Biotech Process Development Associate 3 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 Associate 3, 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. This is an excellent opportunity for a dedicated professional looking to expand their expertise and contribute to cutting-edge research in the biotech industry.

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.
• Troubleshoot and resolve complex technical challenges by analyzing process data, performing root cause analysis, and implementing corrective actions.
• Collaborate with cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Regulatory Affairs, 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 and process validations 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.

Candidate Required 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.
• 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.

Why Wheeler Bio?

• Opportunity to work with cutting-edge biotechnology in a rapidly growing field.
• Competitive compensation and benefits package.
• Collaborative and inclusive work environment.
• Professional development and growth opportunities.