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Lead Scientist in Cell and Gene Therapy
2 months ago
About BioAgilytix: At BioAgilytix, we are dedicated to exceptional science and its transformative impact on healthcare. Our team comprises highly skilled scientists and professionals who provide customized services to support groundbreaking advancements in medicine through top-tier bioanalytical services. We pride ourselves on being solution-focused and meeting deadlines, all while fostering a dynamic and enjoyable work environment. Our diverse client base and various drug modalities offer rapid career development opportunities, allowing you to tackle a range of challenges while contributing to life-saving therapeutics.
Role Overview: As a Lead Scientist specializing in cell and gene therapy, your proficiency in PCR methodologies will be crucial in propelling our innovative research forward. We are in search of a candidate who possesses a rare combination of strategic insight and scientific expertise to spearhead the development and validation of PCR assays within a GxP framework. In this pivotal role, you will oversee and guide a team through the complexities of advanced research, contributing both technical knowledge and a business-focused perspective to ensure alignment with organizational goals.
Key Responsibilities:
- Lead the development, validation, and analysis of bioanalytical methods for the extraction and quantification of specific nucleic acids in CMC, preclinical, and clinical studies supporting the pharmaceutical development of cellular and gene therapies, adhering to GxP standards.
- Drive preclinical and clinical trial initiatives in collaboration with study teams to meet client objectives.
- Maintain regular communication with clients to discuss technical aspects and provide project updates.
- Advise clients on best practices for PCR assays.
- Author and review essential documents, including plans, SOPs, and reports.
- Conduct statistical analyses of PCR data.
- Collaborate effectively to ensure the delivery of high-quality data.
- Mentor and supervise junior scientists, fostering a collaborative and innovative atmosphere.
Required Skills and Qualifications:
- Expertise in molecular biology techniques and proficiency in analysis software.
- Proficient in various techniques, including nucleic acid extraction, real-time PCR, digital droplet PCR, branched DNA assays, and nanostring.
- Demonstrated ability to develop and validate robust nucleic acid extraction methods from diverse, complex biological matrices.
- A talent for designing efficient and impactful experiments.
- Experience or familiarity with regulated environments and a solid understanding of Good Documentation Practices.
- Strong independence, enthusiasm, adaptability, and effective communication skills.
- Ability to motivate and inspire others to achieve their best work and drive results.
- Excellent customer service skills, both internally and externally.
Preferred Qualifications:
- Bachelor's degree with 10+ years, Master's degree with 8+ years, or PhD with 6+ years of bioanalytical lab experience (degree in molecular biology, biochemistry, chemistry, or related field preferred).
- Comprehensive knowledge of regulatory guidelines and industry best practices.
- Experience with nucleic acid extraction and detection.
- Proven expertise in nucleic acid extraction, real-time PCR, digital droplet PCR, branched DNA assays, and nanostring.
- Advanced skills in data analysis and visualization.
- Previous management or supervisory experience.
- Familiarity with GDP, GLP, GCLP, and GCP.
- At least two years of experience in GxP environments.
Why Join Us?: By becoming part of our team, you will gain broad exposure to a diverse range of protein therapeutics, including enzymes, gene and cell therapies, multifunctional therapeutics, and oncolytic viruses. You will have access to a network of expert bioanalytical scientists for collaboration and growth, along with opportunities for continued development and international exposure. We offer competitive healthcare coverage, generous paid time off, a 401k plan with employer matching, and a commitment to equal opportunity in employment.
