Sample Management Technician at BioAgilytix

San Diego, California, United States

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Not SpecifiedCompensation

Entry Level & New GradExperience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

High school diploma
Ability to work under GxP regulations
Ability to work under CAP/CLIA/NYS regulations
Ability to work in a fast-paced team environment where multiple concurrent projects must be completed in a timely manner
Ability to take direction well and multi-task
Acute attention to detail and excellent organizational skills
Excellent oral and written communication skills
Ability to quickly build proficiency in MS Excel, MS Word, LIS, LIMS and Quality Management software
Ability to transition between sitting, standing and walking for up to eight (8) hours per day
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab and office equipment
Frequent mobility needed
Occasional crouching or stooping, with frequent bending

Responsibilities

Accessions samples into LIMS
Imports electronic sample data into eSMS
Provides timely notification of sample receipt to appropriate client/study personnel as needed
Maintains sample chain-of-custody
Reviews study sample demographic data to confirm consistency between sample labels, study paperwork, and electronic sample management systems (eSMS)
Resolves discrepancies, with responsibility for investigating and correcting sample anomalies
Stages samples for testing per schedule/request
Checks out pre-test samples and checks in post-test samples
Ensures samples are ready for analysis on time via sample accessioning and staging schedules
Manages pre- and post-test sample storage
Maintains operability of sample storage units (e.g. routine maintenance, temperature monitoring)
Ships samples to domestic or international destinations
Dispositions samples as directed by client
Provides information for QAU, client, or regulatory agency audit reports as needed
Generates and maintains records in a GxP compliant manner
Assists in collecting metrics data as needed
Recommends process improvements
May receive samples as needed: Receives shipments into Sample Management, Initiates sample chain-of-custody, Provides timely notification of sample receipt to client/BPM
May manage sample-related data as appropriate: Builds study sample metadata in LIMS, Prepares sample manifest files for import into eSMS
Follows BAL SOPs
Other duties as needed

Skills

LIMS

eSMS

GxP

sample accessioning

chain-of-custody

sample storage

temperature monitoring

sample shipping

audit reports

BioAgilytix

Bioanalytical testing for drug development

About BioAgilytix

BioAgilytix offers specialized bioanalytical testing services for the pharmaceutical, biotechnology, and agricultural biotechnology industries, focusing on large molecule studies essential for drug development. They provide various assays, including pharmacokinetics, pharmacodynamics, cell-based, and immunogenicity assays, to measure drug effects and safety. With a global presence, particularly in Europe, BioAgilytix distinguishes itself by its comprehensive testing services tailored to the needs of life sciences companies. Their goal is to support the development and validation of new treatments while ensuring the safety and efficacy of agricultural products.

Durham, North CarolinaHeadquarters

2008Year Founded

$29.3MTotal Funding

GROWTH_EQUITY_VCCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Company Match

Parental Leave

Employee Referral Bonus

Risks

Cancellation of Durham expansion may impact growth and local economic contributions.

Regulatory challenges may arise in US market for Stockholm3 prostate cancer test.

Hamburg lab expansion may strain resources, affecting service quality.

Differentiation

Specializes in immunoassays and cell-based assays for large molecule studies.

Operates globally with significant presence in Europe and the US.

Offers comprehensive suite of assays including PK, PD, and immunogenicity.

Upsides

Increased demand for personalized medicine boosts need for specialized testing services.

Growing market for biosimilars and biobetters expands client base opportunities.

Global cell-based assay market growth aligns with BioAgilytix's expertise.

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