Scientist III - ADA/PK at BioAgilytix

Durham, North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Bachelor’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with at least 12 years’ experience in a scientific laboratory environment; or Master’s degree in the same fields with at least 10 years’ experience; or PhD in the same fields with at least 8 years’ experience
Ability to develop immunoassays in platforms such as ELISA, MSD-ECL, RIA, DELFIA, HTRF, and AlphaScreen
Experience in AAV/gene therapy (preferred)
Work effectively within a team to meet objectives under time constraints
Ability to perform under stress and multi-task
Detail oriented and highly organized
Excellent oral and written communication skills
Proficient in MS Excel and Word
Demonstrated experience serving in a supervisor role and leading teams
Knowledge and application of regulatory guidance to experimental planning and design
Preferred experience working in GxP environments and knowledge of GxP regulations
Ability to use a variety of computer software

Responsibilities

Serve as Bioanalytical Project Manager (BPM) or Principal Investigator (PI) on projects
Prepare and submit deviations
Manage project timelines and scheduling
Manage budget and revenue for projects
Communicate with clients
Train analysts and junior scientists
Develop assays independently
Assist with definition of project scope and proposal preparation (as SME)
Prepare and review scientific training materials (e.g., BAL University)
Set up studies in LIMS system
Serve as lead scientist on assay development projects
Serve as lead scientist on validation
Present data to clients
Independently write plans and reports for validation
Responsible for prompt identification and notification of deviations
Perform assays according to GLP guidelines
Follow GLP guidelines for validation of assays and run assays independently
Prepare worksheets independently, analyze, and interpret data
Write SOPs and plans/reports for sample analysis
Order and keep accurate inventories of supplies for laboratory needs and forecast future needs based on projected project needs

Skills

Bioanalytical Project Management

GLP guidelines

Assay development

Assay validation

LIMS

SOP writing

Data analysis

Client communication

Project timelines

Budget management

Molecular biology

Biochemistry

Immunology

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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