Downstream Purification Process Development Scientist

CuriRx is seeking a highly motivated Downstream Purification Process Development Scientist to join our growing Process Development team. This individual will play a key role in the development, optimization, characterization, and scale-up of purification processes for a broad range of biologic modalities, including therapeutic proteins, monoclonal antibodies, bispecific antibodies, enzymes, viral vectors, and other advanced therapeutics.

The successful candidate will have the opportunity to make significant contributions across multiple client and internal development programs while working within a collaborative, multidisciplinary environment. This position also offers opportunities to provide technical leadership, mentor junior scientists and interns, and participate in the evaluation and implementation of innovative technologies that enhance CuriRx's service offerings and platform capabilities.

Key Responsibilities

Process Development & Optimization

• Design, develop, optimize, and scale downstream purification processes for biologics, including proteins, antibodies, enzymes, and viral-based therapeutics.
• Develop chromatography purification strategies utilizing affinity, ion exchange, hydrophobic interaction, mixed-mode, size exclusion, and membrane-based separation technologies.
• Perform process characterization studies to support process understanding, robustness, and scalability.
• Design and execute experiments using statistical tools and Design of Experiments (DoE) methodologies.
• Optimize filtration, ultrafiltration/diafiltration (UF/DF), viral clearance, concentration, and polishing operations.
• Support technology transfer of purification processes from development to GMP manufacturing environments.
• Prepare technical reports, study summaries, process descriptions, and client presentations.

Laboratory Operations

• Plan and execute laboratory studies while maintaining accurate and complete documentation in laboratory notebooks and electronic systems.
• Analyze and interpret purification performance data and recommend process improvements.
• Operate and maintain AKTA chromatography systems, TFF systems, and associated downstream processing equipment.
• Collaborate with analytical development teams to assess product purity, yield, aggregation, potency, and stability.

Technical Leadership

• Provide scientific guidance and mentoring to research associates, junior scientists, co-op students, and interns.
• Review experimental plans, data analyses, and technical reports prepared by junior staff.
• Lead project discussions and contribute to client-facing technical meetings.
• Support proposal preparation, project planning, and technical risk assessments.

Innovation & Continuous Improvement

• Evaluate and implement emerging purification technologies and platform processes.
• Contribute to continuous improvement initiatives focused on efficiency, scalability, quality, and cost reduction.
• Stay current with industry trends, regulatory expectations, and advances in downstream processing technologies.
• Identify opportunities to enhance CuriRx's purification platforms and service capabilities.

Qualifications

Required

• Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline with 0-5 years of industry experience; or
• M.S. with 3-8 years of relevant industry experience; or
• B.S. with 5-10 years of relevant industry experience.

·        Extensive experience in downstream purification process development for recombinant proteins, antibodies, enzymes, and other biologics, with scale-up expertise supporting production from laboratory scale through 50 L to 200 L bioreactor processes

• Strong understanding of chromatography, filtration, UF/DF, and purification process scale-up principles.
• Experience operating chromatography systems such as AKTA Pure and AKTA pilot.
• Knowledge of biologics characterization techniques and process analytical methods.
• Strong scientific problem-solving, experimental design, and data analysis skills.
• Excellent written and verbal communication skills.

Preferred

• Experience with monoclonal antibodies, bispecific antibodies, recombinant proteins, enzymes, viral vectors, gene therapy products, or vaccine platforms.
• Experience supporting GMP manufacturing, process validation, or regulatory submissions.
• Knowledge of Quality by Design (QbD), Design of Experiments (DoE), and statistical software.
• Experience in a CDMO, biotechnology, or pharmaceutical development environment.
• Familiarity with technology transfer and scale-up activities from bench to pilot or commercial manufacturing.

Core Competencies

• Scientific excellence and innovation
• Strong analytical and critical thinking skills
• Ability to manage multiple projects simultaneously
• Teamwork and collaboration
• Client-focused mindset
• Technical leadership and mentoring
• Attention to detail and quality
• Continuous improvement mindset

Why Join CuriRx?

At CuriRx, you will have the opportunity to work on cutting-edge biologics and advanced therapeutic programs while contributing directly to client success and technology innovation. Our collaborative environment provides exposure to diverse projects, opportunities for professional growth, and the ability to make meaningful scientific and business contributions in a rapidly growing organization.

CuriRx is an Equal Opportunity Employer and values diversity, inclusion, and scientific excellence.

CuriRx, Inc. was founded in 2012, a contract research, development, and manufacturing organization (CRDMO) specializing in biologics, gene therapy, cell therapy, and advanced drug delivery solutions. Our vision is to create new standards of care in therapeutic areas with high unmet medical needs. We do this by partnering with our clients to provide innovative development solutions for pharmaceutics, biopharmaceutics, vaccines, generics, and biosimilars. CuriRx focuses on formulation and lyophilization development of biologics, small molecule, analytical development, and preclinical manufacturing of biologics. The company provides end-to-end services including process development, analytical testing, formulation development, GMP manufacturing support, and regulatory assistance for biotechnology and pharmaceutical clients.