Scientist, III

About BioTissue & Our Culture

At BioTissue, we transform the gift of life by sharing miracles. We are a diverse community, where talent and teamwork are core to who we are. Here, you are empowered to do the work you love, be yourself, and make an impact. Resilient and committed to our vision, we embrace challenges, celebrate courage, and take great pride in our work to create life-changing products. Purpose led us here. Passion and legacy keep us going.

About the Role

The Scientist III will guide the analytical development program and research projects; supervising experiments conducted by analysts and other trainees. This role is responsible for creating, optimizing, and performing cell culture, technical assays, and establishing new research techniques in the R&D laboratory in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). Additionally, the Scientist III will develop analytical methods that measure biological activity, ensure product quality, and meet regulatory requirements for clinical and commercial programs. This role requires expertise in assay development and the ability to collaborate cross-functionally internally and externally to deliver on strategic scientific initiatives.

Responsibilities

• Drive the design, development, optimization, and qualification/validation of analytical and potency assays for biologics and tissue-based products.
• Study scientifically sound mechanism-of-action (MoA)-based assays that are robust, reproducible, and aligned with regulatory expectations.
• Design and execute stability studies, forced degradation studies, and comparability assessments.
• Collaborate closely with process development, manufacturing, and quality control teams to ensure seamless assay transfer, implementation, and lifecycle management.
• Author and review method development reports, validation studies, filings (IND, BLA, 510k), and responses to regulatory agencies.
• Technical report writing and editing for scientific abstracts, scientific presentations, and manuscripts for publications.
• Act as a scientific resource for cross-functional project teams, providing scientific guidance and troubleshooting expertise.
• Supervise experiments conducted by scientists and other trainees.
• Perform molecular biology techniques including immunoassays, ELISAs, cell-based assays, transfection assays, protein isolation, western blotting, RNA extraction, RT-PCR methodology, histology (tissue preparation, staining, and imaging), and immunohistochemistry.
• Author and manage standard operating procedures (SOPs), work instructions (WIs), and other applicable laboratory documentation.
• Lead investigations related to Out of Specifications (OOS) and Out of Trend (OOT) and ensure timely closure of records.
• Stay current on regulatory guidance, industry trends, and emerging technologies in analytical testing.
• Present scientific findings to internal leadership, external partners, and regulatory agencies as needed.
• Mentor and supervise junior scientists and analysts in fostering a culture of excellence and innovation in assay development and data analysis.

Requirements

• Ph.D. in Biology, Biotechnology, Molecular Biology, Biochemistry, Bioengineering, or a related science field required.
• 8 or more years of relevant research industry experience, with a proven track record of scientific achievement.

Skills

• Deep knowledge of analytical testing and cell-based potency assays.
• Strong laboratory skills including but not limited to tissue culturing, biochemistry, cell biology, biostatistics, and molecular biology.
• Experience with assay qualification/validation under ICH/FDA guidance (especially Q8, Q9, Q10, and Q14) is highly desirable.
• Ability to define Analytical Target Profile (ATP), identify CQAs, and establish control strategies.
• Strong leadership skills with prior experience training scientific staff.
• Strong problem-solving, analytical, and organizational skills with attention to detail.
• Excellent communication skills (oral/written).
• Ability to multi-task, setting priorities effectively to produce quality work in a fast-paced professional and cooperative environment.
• Uses observational and reasoning skills to troubleshoot, grasp concepts, patterns, and underlying issues.
• Uses past experiences to help identify likely causes and solutions to problems.
• Uses training and management skills to help others see patterns and concepts by using examples and analogies.
• Statistical Software Proficiency (Minitab, SPSS, or similar) and use of Design of Experiments (DoE) for method optimization.
• Microsoft Office Proficiency (Excel, Word, PowerPoint, Outlook, and Visio).

Physical Requirements

• Ability to work in laboratory and office environments.
• Some travel may be required.

Benefits

• Medical, Dental, and Vision Insurance
• Health Savings Account (HSA) and Flexible Spending Accounts (FSA)
• 401(k) Retirement Savings Plan
• Company-Paid Basic Life and AD&D Insurance
• Voluntary Life and AD&D Insurance
• Short-Term and Long-Term Disability Coverage
• Employee Assistance Program (EAP)
• Legal and Identity Protection Benefits
• Pet Insurance
• Paid Time Off and Company Holidays
• Paid Parental and Birthing Leave
• Family and Medical Leave (FMLA), where applicable
• Tuition Reimbursement and Professional Development Support
• Performance-Based Incentive Opportunities
• Equity or Stock Programs, where applicable

Benefits eligibility and offerings may vary based on position, location, and employment status.