Principal Scientist

Overview of Andelyn Biosciences

The Principal Scientist is an expert level scientist with comprehensive knowledge of scientific principles and concepts not limited to viral vector-based gene therapy. In close collaboration with Laboratory Services leadership, the principal scientist will contribute to innovative solutions that advance the strategy or organization and extend knowledge in the field. He/She will be responsible for leading the planning, execution, and analysis of development experiments, developing, qualifying, and validating new equipment and associated process/methods/assays, and extensive writing and documentation (e.g., SOPs and analytical test methods, qualification/validation protocols and reports, etc.). Secondary responsibilities include providing broad scientific advice and mentorship, peer review of analytical development testing documentation, deviation documentation, provide scientific advice with laboratory investigations, SOP generation or revision, training of junior staff, and other tasks needed to support the primary responsibilities.

• Direct the execution of experiments to satisfy development, qualification, validation, and routine testing as applicable
• Lead the design and execution of experiments without requiring the advice or recommendations from others.
• Displays expert level of technical knowledge of the instruments, assays, and scientific principles used in the laboratory.
• Exercise discretion, judgment, and personal responsibility.
• Respond to, and take action from, alarm notifications from the applicable monitoring system(s) for laboratory temperature-controlled storage units that occur at any point during the assigned period of responsibility>
• Demonstrate high level of integrity.
• Maintain positive attitude
• Operate within the Quality Management System applicable to the manufacture of phase appropriate material in the CMF.
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
• Attention to detail in all job functions.
• Operates in alignment with established policies, procedures, and techniques, requiring relevant training, practical experience, or a working knowledge of the tasks involved.
• Anticipating problems and removing obstacles to enable staff to perform tasks as assigned.
• Work to specific measurable objectives requiring operational planning skill with little direct supervision.
• Cultivate a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of department goals.
• Drives development of procedures.
• Moderate travel required.
• Frequent involvement in customer relations
• Significant responsibility for inspection outcomes.
• Mentoring and professional development of staff.
• Exercise crucial people skills.
• Ability to manage and influence people in direct and lateral support structure
• Have significant latitude for making decisions for their operational or functional unit.
• Drives timelines and development through broad influence
• Minimal interaction with legal services.
• Other duties as assigned.

What you bring to the team.

• Must possess relevant four-year degree OR relevant Master’s OR relevant PhD preferred, background in the life sciences, biotechnology or gene therapy industries preferred.
• Eight years relevant (w/4 YR deg) OR six years with relevant graduate degree or certification.
• Experience in biologics or gene therapy preferred OR extensive experience in highly regulated field.
• Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change.
• Must be proficient in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting.
• Ability to work independently as well as collaboratively in a diverse and inclusive work environment.
• Must possess a client-focused mindset in daily tasks.
• Must possess prior experience handling confidential information and the ability to maintain confidentiality.

• The pride of contributing to the development and manufacturing of life-saving therapies
• The invaluable experience of being a part of building the foundation of a new organization.
• The opportunity to work alongside experts that have over 10 years in the gene therapy field.
• Competitive compensation
• Eligible day one for medical, dental and vision insurance plans with basic vision at 100% company-paid
• 160 hours of Paid Time Off annually
• 11 company-paid Paid Holidays plus 2 floating holidays annually.
• Company-paid Paid Life Insurance
• 401(k) Match
• Company Paid short and long-term disability.
• 4 weeks of Paid Parental Leave for birth and adoption
• Adoption Assistance
• Tuition Reimbursement and Student Loan Repayment Assistance
• Company Paid LinkedIn Learning access.
• Employee Assistance Programs
• Flexible work options (role specific)