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Development Scientist
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Ott Scientific
The Ott Scientific family of companies comprises Polysciences, Bangs Laboratories, and Ethos Biosciences. Together, we bring the whole of our experience with best-in-class facilities and scientific, technical, analytical, and manufacturing capabilities to serve customers around the globe. We deliver highly specialized products and services that support scientific discovery and innovations.
Ethos Biosciences
At Ethos Biosciences, we are a contract development and manufacturing organization (CDMO) that offers private label manufacturing to many of the biggest life science and diagnostic companies around the world. Our core competencies are immunoassays (ELISA/Lateral Flow) as well as specialty and high-volume diagnostic stains, buffers, and reagents. Our laboratories, manufacturing suites, and warehouse areas are purpose built to accommodate these specialty manufacturing and development operations. We occupy a newly built, state of the art, 126,000ft2 stand-alone building in Logan Township, NJ. Proud to be part of Greater Philadelphia, we are 25 miles from Cherry Hill, NJ, 25 miles from Villanova, PA, and 16 miles from Wilmington, DE. Our processes are governed by an ISO 13485/FDA 820 Medical Device certified quality management system (QMS). We exist to drive healthcare innovation by providing diagnostic tools for scientists and practitioners. Every day we design, develop, and manufacturing diagnostic products that are accurate, repeatable, and easy to use. Our vision is to provide gold standard assays for novel biomarkers and critical reagents to institutions pioneering biomedical research and practice.
Position Overview
We are seeking a highly motivated Development Scientist to join our innovative R&D team. In this role, you will play a pivotal role in advancing our medical device portfolio by leading chemistry testing initiatives, conducting rigorous studies on device performance and safety, and driving continuous improvement efforts in manufacturing processes. The ideal candidate is a detail-oriented problem-solver with a strong foundation in analytical chemistry and a passion for translating scientific insights into practical manufacturing enhancements. This position offers the opportunity to contribute to cutting-edge medical technologies that improve patient outcomes.
Key Responsibilities
- Chemistry Testing and Analysis: Design, execute, and validate chemical testing protocols for raw materials, intermediates, and finished medical devices to ensure compliance with regulatory standards (e.g., FDA, ISO 13485) and product specifications.
- Medical Device Studies: Lead preclinical and analytical studies on medical devices, including biocompatibility assessments, stability testing, and performance evaluations under simulated physiological conditions. Analyze data to identify potential risks and optimization opportunities.
- Continuous Improvement in Manufacturing: Collaborate with cross-functional teams to identify inefficiencies in production processes, implement lean manufacturing principles, and develop data-driven strategies for yield improvement, cost reduction, and quality enhancement.
- Process Development and Validation: Support the scale-up of new processes from lab to production, including DOE (Design of Experiments) for optimization and IQ/OQ/PQ validation activities.
- Documentation and Reporting: Prepare comprehensive technical reports, SOPs, and regulatory submissions. Present findings to internal stakeholders and external auditors, ensuring traceability and reproducibility of results.
- Innovation and Problem-Solving: Stay abreast of emerging trends in medical device chemistry and manufacturing technologies; propose and prototype innovative solutions to address complex challenges.
- Compliance and Safety: Adhere to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and environmental health & safety standards in all activities.
- Company-Wide Project Support: Flexibly contribute scientific expertise to any strategic or operational project across the organization as needed to accelerate company goals, including cross-departmental initiatives, new product ideation, troubleshooting urgent production issues, or supporting business development efforts.
Qualifications Required
- Degree in Chemistry, Chemical Engineering, Materials Science, Biomedical Engineering, or a related field.
- Minimum of 3-5 years of hands-on experience in analytical chemistry testing, preferably within the medical device or pharmaceutical industry.
- Proven expertise in conducting studies for medical devices, including knowledge of relevant standards (e.g., ASTM, USP).
- Experience with continuous improvement methodologies such as Six Sigma, Kaizen, or Lean Manufacturing.
- Strong proficiency in analytical techniques, including HPLC, GC-MS, FTIR, and spectroscopy.
- Excellent data analysis skills using tools like JMP, Minitab, or Python/R for statistical modeling.
- Ability to work collaboratively in a fast-paced, multidisciplinary environment.
Preferred
- Certification in Quality Management Systems (e.g., ASQ Certified Quality Engineer).
- Experience with regulatory submissions (e.g., 510(k), PMA) or international standards (e.g., EU MDR).
- Familiarity with manufacturing software (e.g., ERP systems, process simulation tools).
Skills and Competencies
- Technical Skills: Expertise in experimental design, risk assessment (e.g., FMEA), and process validation.
- Soft Skills: Strong communication skills for technical writing and presentations; proactive mindset for driving improvements.
- Other: Ability to handle multiple projects simultaneously, with a focus on deadlines and accuracy.
What We Offer
Culture
Great people
Peer to Peer Recognition
Broader, hands-on work experience
Clean and Modern Equipment & Labs
Competitive Wages & Year-end Bonus
Comprehensive Benefits
Medical Plans with Telemedicine, Rx, & Vision
Dental
Healthcare, Dependent care, & Commuter Flexible Spending Accounts
401(k) with company match
Basic & Supplemental Life Insurance
Accident, Hospital Indemnity, & Critical Illness
Paid Time Off
Short & Long-term Disability
9 Paid Holidays
Must have legal authorization to work in the US and will not require sponsorship.
Ethos Biosciences is an equal opportunity employer. Drug-free workplace. Tobacco-free work site.
Ethos Biosciences does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit and business need.
Equal access to programs, services, and employment is available to all persons. Those applicants requiring reasonable accommodation to the application process and/or interview process should notify a representative of the Human Resources Department.
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