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.

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.

Position Summary

Incumbent will guide the analytical development program and research projects; supervising experiments conducted by analysts and other trainees. The Scientist III will also be responsible for creating, optimizing and performing cell culture, technical assays and establishing new research techniques in the R&D laboratory in accordance to 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.

Essential Duties & 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.
• Responsible for supervising 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.
• Authors and manage standard operating procedures (SOPs), work instructions (WIs) and any other applicable laboratory documentation.
• Leads 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.

Skills & Abilities

• 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 organization 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 to troubleshoot, grasps concepts, patterns and underlying issues. Uses past experiences to help identify likely causes and solutions to problems that might otherwise seem to be unique events. Uses training and management skills to helps others see patterns and concepts by using examples and analogies that relate well to their own experience and current knowledge level.
• 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).

Position Expertise/Qualifications

• 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.

Physical Requirements

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

Total Rewards

At BioTissue, we believe our people are our greatest asset. We offer a comprehensive Total Rewards package designed to support employees' health, financial wellbeing, professional growth, and work-life balance.

Our benefits may include:

• 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.

ADA Statement

BioTissue is committed to providing reasonable accommodations to qualified individuals with disabilities throughout the hiring process and employment lifecycle. If you require assistance or accommodation to participate in the application process or perform the essential functions of a position, please contact us to discuss your needs.

Qualified applicants with disabilities will be considered for employment and may be eligible to perform the essential functions of the position with or without reasonable accommodation.

Equal Employment Opportunity

BioTissue is committed to fostering a workplace where everyone feels valued, respected, and empowered to contribute. We welcome applicants from diverse backgrounds and experiences and are proud to be an Equal Opportunity Employer. Employment decisions are based on qualifications, merit, and business needs, without regard to any legally protected characteristic.