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.

Some required skills for the Scientist position:

• 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

Primary Roles and Responsibilities:

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.

Key Responsibilities:

• 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 technical oversight of CROs, CMOs/CDMOs, and contract testing laboratories.
• Review protocols, methods, data, validation reports, technical reports and troubleshoot method-performance issues.
• Documentation, Regulatory, and Collaboration
• Author and review analytical methods, protocols, reports, specifications, SOPs, and technical assessments.
• Support CMC/regulatory submissions and health authority responses by providing accurate and scientifically justified analytical content consistent with applicable FDA, ICH, USP, and other relevant requirements.
• Serve as a key analytical partner to R&D, Process Sciences, and QC, facilitating transfer of product knowledge and analytical methods from research through development and into GMP testing.
• Partner with R&D on assay development, characterization, and forced degradation studies and with QC on method transfer, validation, troubleshooting, investigations, and GMP readiness.
• Provide analytical subject-matter expertise and technical content to support CMC regulatory submissions, including analytical procedures, method validation, specifications, batch analysis, stability, and justification of specifications, as applicable.
• Provide analytical assessments and supporting documentation for regulatory responses, information requests, and health authority interactions, as needed.
• Assess analytical method, specification, and testing changes for potential impact to established regulatory commitments and provide technical input to Regulatory/CMC and Quality through the change-control process.

Qualifications:

• Ph.D. in a relevant scientific discipline with 2–5 years of industry experience; or M.S./B.S. with 5–8 years of relevant biotechnology or pharmaceutical industry experience.
• Experience in analytical development, validation, transfer, and characterization of biologics.
• Experience translating research-stage assays into methods suitable for product development and GMP use.
• Knowledge of forced degradation and stability-indicating method principles.
• Working knowledge of GMP analytical testing, pharmaceutical quality systems, and applicable ICH, FDA, and USP requirements.
• Experience with GMP investigations, OOS/OOT, deviations, change controls, and CAPAs is desirable.
• Experience working with external laboratories, CROs, or CMOs/CDMOs is preferred.
• Strong scientific problem-solving, data interpretation, technical writing, project management, and cross-functional collaboration skills.
• Strong sense of ownership, accountability, and urgency in driving tasks and projects to completion.

• Health Care Plan (Medical, Dental & Vision)
• Company 401k match up to 4%
• Paid Time Off (Vacation & Sick)
• Holidays
• Stock Option