Analyst III (CMC/GMP) at BioAgilytix

Durham, North Carolina, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

BiotechnologyIndustries

Requirements

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
Ability to carry out routine tasks accurately, following strict methodology to carry out analysis, preparing samples and maintaining and operating standard laboratory equipment
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
Ability to work in an upright and/or stationary position 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 equipment
Frequent mobility needed
Frequent crouching, stooping, with frequent bending and twisting of upper body and neck
Light to moderate lifting and carrying (or otherwise moves) objects, including laboratory equipment, laboratory supplies, and laptop computer, with a maximum lift of 20 pounds
Ability to access and use a variety of computer software
Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
Frequently interacts with others to obtain or relate information to diverse groups

Responsibilities

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
Run assays independently (including HPLC, UPLC, CE, iCIEF, UVVis, SDS-PAGE, Western Blot, ELISA, USP Compendials)
Adhere to provided method/directive
Prepare buffers
Use LIMS system
Participate in sample analysis
Pipetting
Adhere to safety requirements
Keep accurate inventory of supplies for assays
Responsible for accurate record keeping with regard to sponsor's samples, data, and reports (documentation according to GxP guidelines)
Other duties as needed

Skills

HPLC

UPLC

iCIEF

UV-Vis

SDS-PAGE

Western Blot

ELISA

USP Compendials

LIMS

GxP

Assay Development

Assay Validation

Pipetting

Buffer Preparation

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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