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.RequirementsSome required skills for the Scientist position:Experience with one or more of the following is desirable:PCR/qPCR/ddPCR ELISA and other ligand-binding assaysAssays for biomolecular activity and functionBiophysical particle characterizationCell-based and functional assaysSpectrophotometric and fluorescence-based methodsHPLC/UPLC and other chromatographic techniquesNext Generation Sequence (NGS)Compendial testing, including pH, osmolality, appearance, endotoxin, bioburden, and sterilityStatistical analysis and analytical softwarePrimary 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 CharacterizationDevelop, 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 technologiesEstablish method parameters, system suitability criteria, acceptance criteria, and assay controlsEvaluate method performance and investigate sources of analytical variabilityDesign and execute forced degradation studies to understand degradation pathways and support stability-indicating methodsSupport characterization of biological drug substances, drug products, intermediates, and process-related samplesEvaluate analytical data to support product/process understanding, CQAs, and release and stability specificationsGMP and Manufacturing SupportSupport analytical readiness, release, and stability testing for GMP manufacturingLead or participate in GMP investigations, including OOS/OOT and unexpected analytical results, root-cause analysis, and product-impact assessmentsProvide technical support for deviations, change controls, CAPAs, and other quality-system activitiesEnsure analytical activities comply with applicable GMP and data-integrity requirementsMethod Transfer and External LaboratoriesLead or support method transfers to QC and external laboratoriesProvide technical oversight of CROs, CMOs/CDMOs, and contract testing laboratoriesReview protocols, methods, data, validation reports, technical reports and troubleshoot method-performance issuesDocumentation, Regulatory, and CollaborationAuthor and review analytical methods, protocols, reports, specifications, SOPs, and technical assessmentsSupport CMC/regulatory submissions and health authority responses by providing accurate and scientifically justified analytical content consistent with applicable FDA, ICH, USP, and other relevant requirementsServe 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 testingPartner with R&D on assay development, characterization, and forced degradation studies and with QC on method transfer, validation, troubleshooting, investigations, and GMP readinessProvide 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 processQualifications: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 experienceExperience in analytical development, validation, transfer, and characterization of biologicsExperience translating research-stage assays into methods suitable for product development and GMP useKnowledge of forced degradation and stability-indicating method principlesWorking knowledge of GMP analytical testing, pharmaceutical quality systems, and applicable ICH, FDA, and USP requirementsExperience with GMP investigations, OOS/OOT, deviations, change controls, and CAPAs is desirableExperience working with external laboratories, CROs, or CMOs/CDMOs is preferredStrong scientific problem-solving, data interpretation, technical writing, project management, and cross-functional collaboration skillsStrong sense of ownership, accountability, and urgency in driving tasks and projects to completionBenefitsHealth Care Plan (Medical, Dental & Vision)Company 401k match up to 4%Paid Time Off (Vacation & Sick) HolidaysStock Option