Jobs in the United States

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Added 7 mins ago
Scheduler
CACI
Remote, United States
Coordinate scheduling activities across multiple functional and technical workstreams, including software development, integration, testing, deployment, and sustainment efforts
Added 11 mins ago
Senior Manager, Hardware Engineering
HPE
Sunnyvale, CA
We are looking for a highly skilled and dynamic Senior Hardware Manager to join our team and lead the hardware development and release processes. This role is ideal for someone with…
Added 14 mins ago
Senior Linux System Administrator - 306502
Delaware Nation Industries
Dahlgren, VA
…requires the ability to independently solve complex problems, lead technical efforts, develop repeatable processes, and coordinate with Government stakeholders and other engineering…
Added 17 mins ago
J
Senior QA/SDET
Jobgether
Remote, United States
- $180,000 to $210,000 USD / year
Lead performance, load, and reliability testing to ensure APIs and processing pipelines meet latency and throughput expectations.
Added 35 mins ago
Scientist, Process Sciences - Analytical Development
Direct Biologics
Poway, CA
Compendial testing, including pH, osmolality, appearance, endotoxin, bioburden, and sterility
Added 1 hour ago
Associate Director, Staffing and Development
Cornerstone Research US
NY · Chicago, IL · Boston, MA · San Francisco, CA · Washington, DC · Los Angeles, CA
Take ownership of and lead the project staffing process for billable and non-billable projects while accounting for specific case needs, development needs and timing.
Added 2 hours ago
CC
Chief of Commercial Plan Review (re-ad 27-00131)
Chesterfield County
Chesterfield County, VA
- $88,924 to $120,046 USD / year
…administration, including at least two (2) years of supervisory or lead role experience; or an equivalent combination of training and…
Added 2 hours ago
Co-founder & CTO, AI for predictable drug discovery and development
Deep Science Ventures
Remote, United States
…Co-founder & CTO you take a built, already-used platform and lead its development, the research programme that measures and improves its predictions, and the first technical team. The aim…
Added 2 hours ago
Co-founder & CTO, AI for predictable drug discovery and development
Deep Science Ventures
Remote, United States
…Co-founder & CTO you take a built, already-used platform and lead its development, the research programme that measures and improves its predictions, and the first technical team. The aim…
Added 2 hours ago
H
Project Engineer II (Geotechnical)- Chantilly, VA
Hillis-Carnes
Chantilly, VA
- $80,000 to $120,000 USD / year
…specialty construction, construction materials engineering and testing, and third-party…
Added 2 hours ago
Systems & Network Analyst – SECRET Clearance Required
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United States
Lead system upgrades, enhancements, testing, and validation, ensuring compatibility, interoperability, performance, stability, and compliance while minimizing operational risk.
Added 2 hours ago
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Cable Technician
GD Information Technology, Inc.
United States
- $42.27 to $57.19 USD / hour
Responsible for tasks assigned by team lead in connection with move, add, change activities related to copper cabling infrastructure, Voice over IP networks (VOIP), and fiber optic cabling…
Added 2 hours ago
Quality Engineer
ASTEMO AMERICAS, INC.
Berea, KY
…the customer. Overall requirements for this position are to lead/sub-lead all aspects of Motor Quality from RFQ through SOP+3 months. This includes confirmation at the manufacturing…
Added 2 hours ago
Engineer Manager
ASTEMO AMERICAS, INC.
Farmington Hills, MI
…Collaborate with cross-functional teams to design and develop software-defined mobility solutions tailored to specific network requirements and use…
Added 3 hours ago
Counterintelligence Analyst - Active Clearance Required
LLNL
Livermore, CA
Participate in and, as appropriate, lead collaborative analytical projects.
Added 3 hours ago
Sr Cyber Defense Sys Engineer
Constellation
Kennett Square, PA
…maintains, reviews, and administers the infrastructure hardware, software, and documentation that are required to effectively manage network defense. Enables the Cyber SOC to meet key…
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Regional Operations Director East
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…including leak detection, atmospheric corrosion, line location, software service solutions, as well as water, gas, and electric meter reading. We are always looking for motivated…
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Webflow Guru/Website Manager
Veracode
Remote, United States
…trusted by organizations worldwide to build and maintain secure software from code creation to cloud…
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Principal Front-End Engineer, Design Systems
Hewlett Packard Enterprise
Ft. Collins, CO
Lead quality outcomes for significant component initiatives using automated component testing, accessibility validation, and visual regression testing so product teams can adopt changes…
Added 4 hours ago
Senior Manager, Hardware Engineering
Hewlett Packard Enterprise
Sunnyvale, CA
We are looking for a highly skilled and dynamic Senior Hardware Manager to join our team and lead the hardware development and release processes. This role is ideal for someone with…
Added 4 hours ago
PG
Full Stack Engineer – AI Healthcare
Premier Global Links
Mountain View · Mountain View, CA
- $140,000 to $200,000 USD / year
…healthcare technology company developing AI-powered clinical software and ambient documentation…
Added 4 hours ago
C-
Principal Software Engineer - Full Stack
CVector - Industrial AI
Remote, United States
- $150,000 to $175,000 USD / year
As a Principal Full Stack Software Engineer, you will own the technical direction of CVector’s customer-facing platform end to end - from the real-time data visualization and AI-driven…
Added 4 hours ago
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Senior Software Engineer - Full Stack
CVector - Industrial AI
Remote, United States
- $125,000 to $150,000 USD / year
This role requires strong technical judgment, a bias toward shipping high-quality software, and a product-oriented mindset. You should be comfortable working across the stack, learning new…
Added 4 hours ago
Lead Electrical Hardware Reliability Engineer (Starlink)
SpaceX
Bastrop, TX
As a Lead Hardware Reliability Engineer, you will be responsible for the reliability of the Starlink Product hardware from factory to field. You will develop an intimate understanding of…
Added 5 hours ago
CI
Senior Full Stack Product Engineer
CubX Inc.
Lakewood, NJ
- $90,000 to $150,000 USD / year
…successfully used AI coding tools to accelerate professional software development while maintaining ownership of architecture, quality, security, and the final…

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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