Scientist, Process Sciences - Analytical Development

Direct Biologics is a science-based market leading innovator and certified cGMP manufacturer of regenerative biologic products driven by science and innovation. Our company is dedicated to delivering cutting-edge clinical and scientific solutions through meticulous research efforts. Direct Biologics prioritizes patient safety above all else. All regulated processes adhere to cGxP standards, guaranteeing the utmost safety and quality at every phase of product development.

Direct Biologics delivers high-quality products for healthcare providers and patients alike. Our commitment to excellence is upheld through our quality systems, ensuring the consistent provision of safe products. Direct Biologics was established with the goal of advancing the frontier of cutting-edge human cell and tissue technologies. Our company has amassed substantial intellectual property focused on stem cell secretomes and their applications.

• Experience with one or more of the following is desirable:
• PCR/qPCR/ddPCR
• ELISA and other ligand-binding assays
• Assays for biomolecular activity and function
• Biophysical particle characterization
• Cell-based and functional assays
• Spectrophotometric and fluorescence-based methods
• HPLC/UPLC and other chromatographic techniques
• Next Generation Sequence (NGS)
• Compendial testing, including pH, osmolality, appearance, endotoxin, bioburden, and sterility
• Statistical analysis and analytical software

Position Summary:

The Analytical Scientist develops, validates, transfers, and supports analytical methods for the characterization, release, stability, and process development of biopharmaceutical products. The primary technical focus is on molecular biology, biochemistry and cell biology, including, but not limited to PCR, ELISA, next-generation sequencing (NGS), EV and particle characterization, and assays for biomolecular activity and function. The role provides scientific and technical expertise throughout the product lifecycle and collaborates closely with R&D, Process Sciences, Quality Control, Quality Assurance, Manufacturing, Regulatory/CMC, and external laboratories.

• Analytical Development and Characterization
• Develop, optimize, qualify/validate, transfer, and troubleshoot analytical methods for biologics, with a focus on molecular biology and biochemistry, including PCR, ELISA, next-generation sequencing (NGS), and assays of biomolecular activity and function.
• Design, optimize and execute analytical method development, validation, bridging, comparability, and transfer studies using appropriate molecular biology and biochemical technologies.
• Establish method parameters, system suitability criteria, acceptance criteria, and assay controls.
• Evaluate method performance and investigate sources of analytical variability.
• Design and execute forced degradation studies to understand degradation pathways and support stability-indicating methods.
• Support characterization of biological drug substances, drug products, intermediates, and process-related samples.
• Evaluate analytical data to support product/process understanding, CQAs, and release and stability specifications.
• GMP and Manufacturing Support
• Support analytical readiness, release, and stability testing for GMP manufacturing.
• Lead or participate in GMP investigations, including OOS/OOT and unexpected analytical results, root-cause analysis, and product-impact assessments.
• Provide technical support for deviations, change controls, CAPAs, and other quality-system activities.
• Ensure analytical activities comply with applicable GMP and data-integrity requirements.
• Method Transfer and External Laboratories
• Lead or support method transfers to QC and external laboratories.
• Provide…