At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.
As a Principal Investigator in the field of cell and gene therapy, your expertise in PCR methods will play a pivotal role in advancing our groundbreaking research. We are seeking a candidate with a unique blend of strategic acumen and scientific proficiency to lead the development and validation of PCR assays in a GxP environment. As a key player, you will have direct oversight, guiding the team through the intricacies of cutting-edge research. You will not only bring technical expertise but also a business-oriented mindset, ensuring alignment with organizational objectives. This role offers the opportunity to manage and mentor junior scientists, fostering a collaborative and innovative environment at the forefront of cellular and gene therapy advancements.
As a Principal Investigator your day-to-day activities will include:
- Lead bioanalytical method development, validation, and sample analysis for the extraction and quantitation of specific nucleic acids for CMC, preclinical and clinical studies supporting the pharmaceutical development of cellular and gene therapies, according to GxP principles
- Drive pre-clinical and clinical trial projects with study team to align with client objectives.
- Frequent communication with clients to discuss technical details and provide project updates
- Advise clients on PCR assay best practices
- Author and review documents (plans, SOPS, reports)
- Statistical analysis of PCR data
- Work collaboratively to deliver high quality data
- Mentor and supervise junior level Scientists
These are skills needed to be successful:
- Expertise in molecular biology techniques and in analysis software
- Proficiency in more than one of the following techniques: nucleic acid extraction, real-time PCR, digital droplet PCR, branched DNA assays, nanostring
- Demonstrated ability to develop and validate robust nucleic acid extraction methods from multiple, complex biologic matrices
- A knack for designing efficient and impactful experiments
- Experience or familiarity working in a regulated environment, with a thorough understanding of Good Documentation Practices
- Independence, enthusiasm, openness, and adaptability
- Effective communication skills
- Motivation and an ability to inspire others to do their best work and drive results
- Excellent customer service skills (internal and external)
Qualifications and Competencies Preferred:
- BS with 10+ years, MS with 8+ years’, or PhD with 6+ years’ bioanalytical lab experience (Degree in molecular biology, biochemistry, chemistry, or related field preferred)
- A thorough knowledge of regulatory guidance and industry best practices
- Experience with nucleic acid extraction and detection
- Demonstrated expertise in nucleic acid extraction, real-time PCR, digital droplet PCR, branched DNA assays, nanostring
- Advanced capabilities in data analysis, data visualization statistical analysis
- Previous management/supervisor experience
- GDP, GLP, GCLP, GCP
- Not less than two (2) years’ experience in GxP environments
The benefits of joining our team:
- Broad exposure to a wide variety of protein therapeutics (enzymes, gene & cell therapy, multifunctional therapeutic, oncolytic virus)
- Access to a network of expert bioanalytical scientists to collaborate with and grow
- Continued development and growth, international sites exposure and contacts
- Exposure to cutting-edge bioanalytical technologies
- Highly competitive healthcare coverage (HDHP with HSA; PPO), dental and vision
- Competitive Paid Time Off (4 weeks per year) + Paid Holidays (12 scheduled; 3 floating)
- 401k with Employer Match
BENEFITS AND OTHER PERKS
Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (12 scheduled; 3 floating), 401k with Employer Match, Employee Referral Program
COMMITMENT TO EQUAL OPPORTUNITY
BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.