Prism Biotech

Prelaunch prescriber profiling and targeting

Laboratory IT Associate

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeKing of Prussia, PA, USANo salary listedIn-person

About the Job

Requirements

A bachelor's degree in computer science, life science, or applied science.
At least five years of demonstrated relevant experience in a good manufacturing practice laboratory.
Ability to work in a laboratory environment while wearing appropriate personal protective equipment and other safety-related equipment.

Responsibilities

Perform or support laboratory validation of laboratory equipment and software systems.
Support the establishment and maintenance of the validated state of software-based computerized systems used in the laboratory.
Act as the business owner and contact subject-matter expert for quality control laboratory information technology systems.
Collect data and author periodic review documents for laboratory information systems.
Provide oversight and support for continuous improvement of quality systems as they relate to laboratory informatics.
Apply knowledge of quality principles, current good manufacturing practice, and laboratory systems to develop and execute local procedures, training courses, and practices.
Improve quality systems by creating or revising worksheets, developing or updating laboratory execution system documentation, updating laboratory methods, and maintaining other laboratory documentation systems.
Manage methods in the quality control laboratory, specifically scripted or coded methods.
Support or lead investigations, corrective and preventive action, and change control initiatives.
Maintain a safe work environment and support health, safety, and environmental corporate and site goals.

Desired Qualifications

Experience with computer systems, including the Microsoft Office suite and laboratory information management systems.
Investigation and deviation management experience.
Demonstrated proficiency in computer system validation.
Experience with compliance requirements and regulatory expectations.
Demonstrated accuracy and proficiency in analytical skills.
Strong oral and written communication skills demonstrated through documentation and presentation skills.
Demonstrated strong interpersonal interaction skills.

This role will serve as a business representative for laboratory IT systems and will be responsible for mentoring laboratory personnel on the use of electronic lab systems as well as supporting internal and external audits as a laboratory IT system subject matter expert.

Key Objectives/Deliverables:

Performs or supports Laboratory with the validation of laboratory equipment and software systems.
Supports the establishment and maintenance of the validated state of software-based computerized systems in use in the laboratory.
Act as business owner and contact SME for QC laboratory IT systems.
Responsible for collecting data and authoring periodic review documents for laboratory information systems.
Provide oversight and support continuous improvement of quality systems as they relate to laboratory informatics.
Apply knowledge of quality principles, cGMP, and laboratory systems towards the development and execution of local procedures, training courses, and practices.
Assist in improvement of quality systems by creating or revising worksheets, developing, or updating laboratory execution system documentation, updating laboratory methods, and maintaining other lab documentation systems.
Responsible for method management in the QC Laboratory, specific to scripted or coded methods.
Supports and/or leads investigations, CAPA and change control initiatives.
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.

Requirements (Education, Experience, Training):

Bachelor’s degree in a computer science, life science, or applied science with at least five (5) years of demonstrated relevant experience in a GMP lab.

Preferred attributes but not required:

Experience with computer systems including Microsoft Office suite, laboratory information management systems.
Investigation and deviation management experience.
Demonstrated proficiency in computer system validation.
Experience with compliance requirements and regulatory expectations.
Demonstrated accuracy and proficiency in analytical skills.
Strong oral and written communication skills and demonstrated through documentation and presentation skills.
Demonstrated strong interpersonal interaction skills.

About the Company

Prism Biotech

Prelaunch prescriber profiling and targeting

Prism Biotech provides field sales and medical affairs services to support pharmaceutical launches. It deploys pharmaceutical sales reps and medical science liaisons before product approval to collect prescriber information through office visits. The data gathered is combined with existing records to create a profile of key prescriber targets and disease states. This profiling happens before a launch so the sales team is prepared with identified targets and relevant physician insights. Prism Biotech differentiates itself by offering a full-service prelaunch target physician profiling workflow, aligning early market intelligence with product planning. The company’s goal is to prime and ready the sales force with accurate, ready-to-target physician profiles ahead of a brand’s approval and launch.

Company size: Not listed
Company stage: Not listed
Total funding: Not listed
Headquarters: Upper Merion Township, Pennsylvania
Founded: 2019

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