Principal Scientist, Analytical Development

Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medical products, including a robust extracellular vesicle based biologic platform technology. The Company is committed to providing the latest clinical and scientific information through rigorous and thorough research. With deep knowledge and industry expertise in cellular and regenerative therapies, the company has brought to market a significant development in therapeutic biologics with the introduction of the highest quality production of extracellular vesicles.

Requirements

Some required skills for the Principal Scientist position:

• Top expert in biotechnology analytical method life cycle, with demonstrated success managing late-stage to commercial cell-based assay validation.
• Extensive knowledge of domestic and global regulatory requirements for late-stage and commercial analytical testing programs.
• Excellent scientific, communication, and time management skills.
• Prior experience speaking to health authorities about analytical methods and control strategies (pre-licensure inspection experience preferred).
• Track record of success in analytical method transfer and lifecycle management at contract testing laboratories.
• Ideal candidate will be a recognized leader in commercial readiness activities for mechanism-of-action reflective potency assays for regenerative therapy products.
• Ideal candidate has prior experience directing resources in a matrixed environment and/or managing direct reports.

Primary Roles and Responsibilities:

• Responsible for late-stage in-process and release analytical method development, qualification, validation, and life-cycle management.
• Owner of assay control strategies for internally developed assays, with a particular emphasis on cell-based potency methods.
• Inter-departmental scientific and strategic leader of proactive and reactive initiatives to improve test methods, in collaboration with R&D and QC personnel.
• Leads timely troubleshooting, investigations, and continuous improvements related to quality events.
• Drives effective communication between cross-functional stakeholders, partner organizations, and governance teams.
• Authors technical documents including method SOPs, development reports, qualification protocols/reports, and QBD risk assessments.
• Supervises method robustness, control strategy development, and validation at partner organizations.
• Occasional travel is required to participate in on-site vendor activities, such as analytical method transfer, vendor meetings, and vendor quality audits.
• Excels in a fast-paced environment. Independently prioritizes activity based on importance and urgency, manages time well, anticipates challenges, and delivers progress in line with program goals.

• Strong attention to detail and scientific integrity.

Qualifications:

•  Bachelor’s Degree in Cell Biology, Analytical Chemistry, or related field is expected.

•  Advanced degree preferred.

• Minimum of 8 years of experience (or PhD + 4 years) developing analytical methods for testing of biotechnology products and intermediates.

• Expertise in cell biology, inflammation, immunology, and autoimmunity.

• Prior success with complex scientific and operational challenges related to designing and developing GxP potency assays, particularly in regenerative medicine applications.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Company 401k match up to 4%
• Paid Time Off (Vacation & Sick)
• Holidays
• Stock Option