Laboratory Application Specialist – BioA Analytical Services
Title: Laboratory Application Specialist
Location: Exton, PA
Reports to: IT/BioA Analytical Lab Services Manager
Full-time (40 hrs./week)
Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position/Job Summary:
As a subject matter expert (SME), the Laboratory Application Specialist implements, supports, enhances, maintains, and administrates BioA Analytical Laboratory software applications (e.g., Watson, IDBS, eBinders, Analyst, etc.), instrument integration and lab testing data management, such as Simoa-Watson LIMS integration used in the Frontage lab BioA Analytical Services laboratories. The primary responsibilities of this position will be to provide leadership in lab software/application implementation and validation, administration, data management, user support, troubleshooting cross all BioA laboratories to meet operational and regulatory requirements of computer systems and data integrity in labs.
Roles & Responsibilities:
- Provide support, instrument qualification and software validation, enhancement, and administration of laboratory instruments and related software.
- Support lab software application configurations related to lab instrumentations.
- Complete documentation for the support of software changes and upgrades.
- Drive technology improvements and efficiency opportunities to improve business and compliance.
- Contribute to change controls and procedures specific to laboratory software.
- Coordinate/interface/host vendors on site, when applicable.
- Point of contact for communication between Corporate IT and laboratory groups.
- Manage data integration of various instruments and computer system applications.
- Provide training in software access and functionality.
- Ensure the software applications are validated to 21 CFR Part 1 compliance and always maintained in validated state.
- Other duties as assigned.
Education, Experience & Skills Required:
- Bachelor's degree in relevant scientific, engineering, or computer-based area with ≥3 years' experience in the pharmaceutical industry or equivalent combination of education and IT and/or lab experience.
- Knowledge of GXP regulatory requirements, computerized analytical systems (i.e., 21 CFR part 11) and data integrity.
- Knowledge of Watson, IDBS, Analyst Administration and other Analytical lab software programs, including Microsoft Office Applications.
- Must have GxP experience.
- Excellent organization, planning, and communication skills.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Skills Required
- Bachelor's degree in scientific, engineering, or computer-based area
- ≥3 years' experience in the pharmaceutical industry
- Knowledge of GXP regulatory requirements and data integrity
- Knowledge of Watson, IDBS, and Analyst software programs
- Excellent organization, planning, and communication skills
What We Do
Frontage Laboratories, Inc. is a CRO that provides integrated, science-driven, product development services throughout the drug discovery and development process to enable pharmaceutical and biotechnology companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of molecules through development and file regulatory submissions in the United States, China and other countries.
