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.
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.
The Technical Analyst II/III will perform responsibilities of a traditional lab analyst, peer reviewer, and new system implementation specialist. Tasks will encompass running assays, reviewing data, and devising and implementing solutions tailored for both short-term and long-term objectives. Playing a pivotal role in our project lifecycle, you'll conduct validation studies on a spectrum of biological samples, ranging from biologics and proteins to peptides, small molecules, and biomarkers, collaborating closely with a proficient team of scientists. With each project presenting unique challenges, you'll have the opportunity to engage with a diverse array of analytical instrumentation and methodologies.
Essential Responsibilities: Laboratory

• Prepare worksheets with minimal supervision
• Prepare plate maps
• Serve as lead analyst on sample analysis projects
• Troubleshoot assays
• Compile/process data (make power export)
• Prepare summary tables
• Peer review raw data
• Order reagents
• Participate in assay development and validation
• Responsible for accurate record keeping with regard to sponsor's samples, data, and reports (documentation according to GxP guidelines)
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Essential Responsibilities: Data Review & Documentation

• Perform Quality Control (QC) technical and scientific and compliance review of data and documentation generated by the Bioanalytical Operations group in support of regulated studies (e.g. GLP, GMP) and non-regulated
• Identify deviations, OOS and OOT associated with Bioanalytical Operations data as applicable
• Issue QC review observations and work closely with the scientific staff to ensure data integrity
• Collect metrics data used to monitor the QC reviews
• Follow QCT SOPs
• Responsible for second-level technical reviews of documents prior to review by the project manager (e.g., Bioanalytical Project Manager (BPM), Principal Investigator)
• independently creating reports, plans, and submission documents in support of internal BioAgilytix projects
• Extracts and formats data from multiple lab systems (e.g., LIMs, SoftMax, FACs) to generate reports

Essential Responsibilities: System Facilitator

• Support system implementation and updates, such as Watson LIMS or automation; liaise with all parties to promote adoption of systems for increased efficiency
• Creates and manages system Standard Operating Procedures (SOPs), as needed
• Creates and manages validation documents in internal quality management systems
• Responsible for troubleshooting and overseeing resolution of technical issues that arise from the use of the LIMS
• Plans future workflow improvements including but not limited to the implementation of new processes and integration of new systems

Additional Responsibilities

• Other duties as needed

Minimum Preferred Qualifications - Education/Experience ((Technical Analyst II):

• Bachelor's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with more than two (2) years' experience in a scientific laboratory environment; or
• Master's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with more than one (1) year experience in a scientific laboratory environment
• Experience using Watson LIMS

Minimum Preferred Qualifications - Education/Experience ((Technical Analyst III):

• Bachelor's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with more than four (4) years' experience in a scientific laboratory environment; or
• Master's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with more than two (2) years' experience in a scientific laboratory environment; or
• PhD in molecular biology, biochemistry, immunology, biotechnology, or related field with one (1) year experience in a scientific laboratory environment
• Experience using Watson LIMS

Minimum Preferred Qualifications - Skills:

• Ability to carry out routine tasks accurately, following strict methodology to carry out analysis, preparing samples and maintaining and operating standard laboratory equipment.
• Demonstrated ability to use and troubleshoot Watson LIMS
• Must work effectively within team to meet objectives under time constraints
• Ability to take direction well and multi-task
• Detail oriented and highly organized
• Experience working in a GxP environment preferred
• Excellent oral and written communication skills
• Proficient in the use of MS Excel and Word

Supervision Received:

• Frequent supervision and instructions
• Infrequently exercises discretionary authority

Working Environment:

• Primarily laboratory environment
• Exposure to biological fluids with potential exposure to infectious organisms
• Rare exposure to skin and lung irritants, toxic materials, and hazardous waste
• Personal protective equipment required, such as protective eyewear, garments, and gloves
• Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets

Position Type and Expected Hours of Work

• This is a full-time, on-site position
• Some flexibility in hours is allowed, but the employee must be available during the "core" work hours as published in the BioAgilytix Employee Handbook
• Occasional weekend, holiday, and evening work required

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.
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.