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Added 43 mins ago
Scientist, Process Sciences - Analytical Development
Direct Biologics
Poway, CA
The Analytical Scientist develops, validates, transfers, and supports analytical methods for the characterization, release, stability, and process development of biopharmaceutical products.…
Added 5 hours ago
CI
Preclinical Principal Scientist, Research & Development
Cresilon, Inc.
Remote, United States
- $130,000 to $210,000 USD / year
The Preclinical Principal Scientist will serve as a key scientific contributor, subject matter expert (SME), and Project Manager in the execution of Cresilon’s Preclinical Research…
Added 5 hours ago
CI
Manager/Principal Scientist Research & Development - Polymer Formulation
Cresilon, Inc.
Brooklyn, NY
- $130,000 to $180,000 USD / year
The R&D Manager / Principal Scientist will serve as a subject matter expert in polymer materials science, formulation strategies, analytical chemistry, and biomaterial interactions with…
Added 5 hours ago
Data Scientist- AFCENT 4.45
Credence
Shaw AFB, SC
Credence has an upcoming need for a Data Scientist to support of the 9AF (AFCENT) Intelligence Directorate (9AF (AFCENT)/A2) Directorate mission in the United States Central Command…
Added 6 hours ago
Data Scientist - JETARS
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Offutt AFB, NE
…Data Science and Analytics Professional to support advanced analytical initiatives focused on large language model (LLM) integration, intelligent automation, and data-driven insights. The…
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Senior / Staff Scientist, Assay Automation
Clear Labs
San Carlos, CA
Contribute to analytical validation activities (LoD, precision, specificity, reproducibility, interference).
Added 11 hours ago
M
Associate Production Scientist - 12 Hour
MILLIPORESIGMA
SHEBOYGAN FALLS, WI
- $27 to $48 USD / hour
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ND
Principal Scientist, Upstream Process Science
NantKwest Dba Immuni
Louisville, CO
- $34,986 USD / year
The Principal Scientist, Upstream Process Sciences role will manage the team responsible for upstream process development, process characterization, and scientific support activities for…
Added 12 hours ago
Data Scientist
Paragon Cyber Solutions
Washington, DC
Paragon Cyber Solutions is seeking a Data Scientist to support a Government intelligence mission. In this role, you will apply statistics, machine learning, data mining, and other data…
Added 12 hours ago
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Medical Lab Scientist II
CommonSpirit Health
West Jordan, UT
- $30.76 to $45.76 USD / hour
As our Medical Lab Scientist II (non-CA), you will oversee the day-to-day operations of an assigned shift or department, performing general testing within the analytical core laboratory,…
Added 13 hours ago
Clinical Laboratory Scientist - Sharp Memorial - Night Shift - Per Diem
Sharp HealthCare
San Diego, CA
California Clinical Laboratory Scientist (CLS) Generalist license - CA Department of Public Health; Other; California Clinical Toxicologist Scientist License - CA Department of Public…
Added 15 hours ago
Senior Computational Biologist / Non-Tenure-Track Assistant Professor / Faculty Research Scientist
NYU Langone Medical Center
New York, NY
The Skok Lab at NYU Grossman School of Medicine is seeking an experienced computational scientist tolead the development of computational approaches for single-molecule epigenomics and 3D…
Added 15 hours ago
Associate Data Scientist
Moody's Analytics
NEW YORK, NY
…methodologies. * Strong proficiency in programming languages and analytical applications (Python, R, etc.). * Ability to work independently on multiple projects, manage deadlines, and…
Added 17 hours ago
Power Markets Data Scientist and Optimization Analyst - Hybrid Remote
Hoosier Energy
Bloomington, IN
Pay Grade:M08 POSITION SUMMARY The Power Markets Data Scientist and Optimization Analyst develops advanced analytical models, forecasting solutions, optimization frameworks, and…
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(USA) Distinguished, Data Scientist - Operations Research
Walmart
BENTONVILLE, AR
- $130,000 to $260,000 USD / year
Mentor team members on analytical methods, model validation, and best practices to enhance overall data science capabilities.
Added 18 hours ago
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Staff Scientist - Assessment (ESA/PCA)
Blew & Associates, P.A.
Remote, United States
- $70,000 to $95,000 USD / year
BLEW is excited to announce an opening for a Staff Scientist specializing in Environmental Assessments. In this role, you will be instrumental in managing projects that involve both…
Added 19 hours ago
UO
Open Rank Regular Faculty: Assistant - Full Professor
University of Colorado Denver
Aurora, CO
- $110,000 to $150,000 USD / year
Five years as an Assistant Professor or equivalent research scientist rank
Added 21 hours ago
Scientist I, Analytical Research & Development
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The Scientist I develops, qualifies, validates, and implements analytical methods for Quality Control (QC) use to support pharmaceutical development and manufacturing, primarily for…
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Springfield, VA
We are seeking a talented and motivated Data Scientist to perform advanced data analysis using statistical and quantitative methods, develop impactful visualizations to support…
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Senior Data Scientist
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As a Senior Data Scientist at Atria, you will generate the medical insights and forecasts that shape how our clinicians care for members and how Atria runs as a practice. You'll work with…
Added 23 hours ago
Lead Clinical Lab Scientist
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Added 23 hours ago
Medical Laboratory Scientist - CORE (Chemistry) - Evenings
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This Medical Laboratory Scientist position offers the opportunity to work in a technologically advanced laboratory where precision, analytical thinking, and collaboration directly impact…
Added 1 day ago
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NeuroHire is seeking a motivated and analytical Data Scientist to join our team. In this role, you will work with structured and unstructured datasets to discover meaningful patterns,…
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Lead Medical Lab Scientist Evenings Blood Bank
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Performs assigned pre-analytical activities related to laboratory testing, including equipment maintenance, function checks, inventory control, specimen collection, biological specimen…

Direct Biologics

Scientist, Process Sciences - Analytical Development

Poway, CA, United States

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Job details

Experience: 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.
Posting language: English
Posted: Sep 15, 2026

Original job description

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

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More about this job

Skills

Statistics
Molecular biology
Quality control
Quality assurance
Troubleshoot
Good manufacturing practices
Root cause analysis
Technical support
Documentation
Collaboration
Product knowledge
Research
Troubleshooting
Biotechnology
Pharmaceutical industry
Quality control systems
Problem solving
Technical writing
Project management

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