Principal Investigator @ BioAgilytix

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.

As a Principal Investigator your day-to-day activities will include:

These are skills needed to be successful:

Qualifications and Competencies Preferred:

The benefits of joining our team:

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