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Scientist III
Doral, FL, US
Scientific
Doctorate/PhD
Full Time, Direct Hire
$130,000-160,000/year
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Doral, FL, US
$130,000-160,000/year
Experienced (Non-Manager)
Full Time, Direct Hire
Biotechnology/Pharmaceuticals
On-site
Scientific
Doctorate/PhD
First Shift (Day)
Job details
Join a leader in regenerative medicine developing innovative biologic therapies that harness human tissue to improve healing and patient outcomes, particularly in ophthalmology and wound care. As a Scientist III, you’ll play a key role in advancing product and process development, leading analytical and experimental work, and supporting GMP activities to ensure quality and regulatory compliance. This is an opportunity to work hands-on with cutting-edge science, collaborate cross-functionally, and contribute directly to therapies that make a meaningful difference in patients’ lives.
Shift: Monday-Friday 1st Shift
Employment Type: Full Time; Direct Hire
Hybrid work schedule available, 3 days onsite, 2 days work from home with flexibility to work full weeks onsite to meet business needs.
Position Summary:
The Scientist III leads analytical development and research projects, supervising lab staff and trainees. Responsibilities include creating, optimizing, and performing cell culture and technical assays, establishing new research methods, and ensuring compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). The role requires expertise in assay development, method validation, and cross-functional collaboration to meet regulatory needs for clinical and commercial programs.
Key Responsibilities
- Develop, optimize, and validate analytical and potency assays for biologics and tissue-based products.
- Design and conduct stability, degradation, and comparability studies.
- Collaborate with process development, manufacturing, and quality control teams for seamless assay implementation.
- Author and review technical reports, scientific abstracts, manuscripts, and regulatory filings (IND, BLA, 510k).
- Supervise experiments and mentor junior scientists and analysts.
- Perform a range of molecular biology techniques (e.g., immunoassays, ELISAs, cell-based assays, protein isolation, western blotting, RT-PCR, histology, immunohistochemistry).
- Manage laboratory documentation (SOPs, WIs).
- Lead investigations for Out of Specifications (OOS) and Out of Trend (OOT) issues.
- Stay updated on regulatory guidance, industry trends, and emerging analytical technologies.
- Present findings to internal teams, external partners, and regulatory agencies.
Qualifications:
- Ph.D. in Biology, Biotechnology, Molecular Biology, Biochemistry, Bioengineering, or related field, with 8+ years of relevant industry experience.
- Expertise in analytical testing, cell-based potency assays, laboratory techniques (tissue culture, biochemistry, cell biology, biostatistics, molecular biology), and assay qualification/validation under ICH/FDA guidance (Q8, Q9, Q10, Q14).
- Strong leadership and training experience, problem-solving skills, and attention to detail.
- Excellent communication and organizational abilities; capable of managing multiple priorities in a fast-paced environment.
- Proficient in troubleshooting, statistical software (Minitab, SPSS, etc.), Design of Experiments (DoE), and Microsoft Office Suite.
Interested? Please apply today for immediate consideration!
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