Applications Engineer—Pharma/BioPharma
On-siteNorth Charleston, South Carolina, United States
Job Summary
Lead application development and performance testing for pharmaceutical and biopharmaceutical purification applications. Design and execute laboratory studies focused on impurity removal, process optimization, and adsorption performance. Develop technical data packages supporting customer qualification and commercialization efforts. Drive pharmacopoeial and regulatory compliance initiatives, including USP and European Pharmacopoeia requirements. Engage directly with pharmaceutical companies, biopharma organizations, and CDMOs to understand needs and provide technical support. Present scientific findings at customer meetings, industry conferences, and technical forums. Collaborate with R&D, Operations, Quality, and Commercial teams to develop pharmaceutical-grade product specifications and support scale-up activities. Monitor industry trends, competitive technologies, and emerging regulatory requirements.
Required Qualifications
- Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, Chemical Engineering, Biochemistry, or related field
- 5+ years (Ph.D.) or 8+ years (M.S.) of pharmaceutical or biopharmaceutical industry experience
- Hands-on experience in pharmaceutical purification, process development, impurity removal, or separation technologies
- Strong analytical chemistry expertise, including techniques such as HPLC/UPLC, mass spectrometry, ICP-MS, or related methods
- Knowledge of pharmaceutical regulatory and quality requirements
- Ability to communicate complex technical concepts to customers and internal stakeholders
Desired Qualifications
- Master's degree with significant relevant experience
- Experience with activated carbon, adsorption science, or specialty materials
- Familiarity with USP, European Pharmacopoeia, ICH, and GMP requirements
- Experience supporting regulatory submissions, technical dossiers, or Drug Master Files (DMFs)
- Knowledge of biologics, monoclonal antibody purification, or ADC manufacturing processes
- External presentation, publication, or conference speaking experience
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