In this role, you will lead the development and validation of Biomarker assays to bring new therapies to market. This role is never boring due to our wide variety of clients and broad ranges of medicine treating different types of diseases. You’ll work in a milestone driven environment generating data, evaluating the performance of the medicine and context of use. Data integrity and quality are important to us, and this role will integrate the expectations in a highly regulated setting.
We are looking for candidates who get energized by working with the newest bioanalytical technologies to solve complex challenges. The best candidates are curious and continuous learners, who have experience in a highly regulated environment, where data integrity is expected and honored. You’ll enjoy and crave collaboration with a network of expert scientists, all while welcoming the opportunity to manage multiple projects, sponsors and project timelines. If you are adaptable and able to inspire the best results, then you’ll be right at home here at BioAgilytix.
Essential Responsibilities
• Develop and validate Biomarker assays for novel therapeutics
• Plan and direct experimental design and execution
• 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 Biomarker assay best practices
• Author and review documents (plans, SOPs, reports)
• Data analysis and interpretation
• Work collaboratively to deliver high quality data
Minimum Preferred Qualifications
Skills:
• A background in assay development and validation
• Experience with biomarkers and/or PK assays
• A talent for designing efficient and impactful experiments
• Experience or familiarity working in a regulated environment, with a thorough understating 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)
Education/Experience:
• BS with 5+ years, or a PhD with 2+ years lab experience
• Bioanalytical lab experience
• A thorough knowledge of regulatory guidance and industry best practices for Biomarker and/or PK assays
• Demonstrated expertise in assay development
• Advanced capabilities in data analysis, data visualization statistical analysis
• Ligand-binding Assay (e.g. ELISA, MSD, Luminex) assay development and validation
• Microsoft Office, MSD workbench, SoftMAX Pro, Watson, Graphpad Prism,
• GDP, GLP, GCLP, GCP
Work Environment Highlights (Boston)
• Broad exposure to a wide variety of therapeutic products (enzymes, gene & cell therapy, multifunctional therapeutic, oncolytic virus)
• Unlimited opportunities to solve biomarker challenges and help bring novel therapies to market
• Access to a network of biomarker and 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 including medical offered through BCBS (HMO/PPO), dental, and vision
• Flexible Spending Accounts for medical expenses and dependent care expenses
• 401K plan with employer match
• Free Parking
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 (10 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.
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