Laboratory Application Specialist-Large Molecule
Department: Biomarker & Biologics
Location: Onsite Frontage 760 site
Employment Type: Full-time
Frontage Laboratories
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. 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 Summary:
Laboratory Application Specialist-Large Molecule — a role that is to support lab operational and studies in a regulated (GLP/GCLP) research environment, including but not limited to documentation and data archival, sample handling, and other activities to support the studies. This role will support project PIs (principal investigator) with documentation, and coordination tasks, sample handling, ensuring compliance with GLP/GCLP standards and efficient study progression from setup to completion.
Key Responsibilities:
1. Laboratory Operations Support- Assist in daily laboratory activities such as sample management, labeling, preparation, and storage.
- Maintain laboratory supplies, reagents, and consumables inventory to support ongoing projects.
- Support instrument setup, calibration, and routine maintenance under supervision.
- Other assigned tasks
- Support study PIs with project documentation and study setup tasks.
- Assist in compiling data summaries, study logs, and project documents and reports.
- Assist and maintain study records, worksheets, and study files according to SOPs.
- Ensure all documents are reviewed, signed, and filed accurately.
- Support document archival and retrieval activities per GLP/GCLP and company retention requirements.
- Assist with electronic document uploads and metadata entry in LIMS or document management systems.
- Follow all company SOPs, GLP/GCLP requirements, and data integrity standards.
- Identify opportunities to improve relative workflows or documentation processes.
- Support implementation of digital tools for study tracking or data management.
- Participate in cross-functional process improvement initiatives.
Qualifications:
Education:
- Bachelor’s degree in Life Sciences, Biology, Chemistry, Biochemistry, or a related scientific discipline.
Experience:
- 0–3 years of experience in lab assistant, document management, or records management (preferably in a regulated industry such as pharmaceutical, biotech, or CRO).
- Experience with document control systems (e.g., SharePoint, Documentum, or similar).
- Familiarity with regulatory documentation standards (e.g., GxP, GLP) preferred.
Skills:
- Strong organizational and time management abilities with attention to detail.
- Excellent communication and interpersonal skills.
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
- Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
- Analytical mindset with focus on process accuracy and compliance.
Core Competencies:
- Accountability and ownership
- Process-oriented and detail-focused
- Team collaboration and cross-functional coordination
- Data and document integrity awareness
- Problem-solving and initiative-taking
Preferred Qualifications (optional):
- Experience in a laboratory, clinical, or regulatory documentation setting.
- Knowledge of long-term data retention and archival best practices.
- Familiarity with electronic archiving systems and metadata management.
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 Life Sciences, Biology, Chemistry, Biochemistry, or a related scientific discipline
- 0–3 years of experience in laboratory assistance, document management, or records management
- Experience with document control systems such as SharePoint, Documentum, or similar
- Proficiency with Microsoft Office Suite, including Excel, Word, and PowerPoint
- Strong organizational, time management, communication, and interpersonal skills
- Ability to manage multiple priorities and meet deadlines in a fast-paced environment
- Analytical mindset focused on process accuracy and compliance
- Familiarity with GxP or GLP regulatory documentation standards
- Experience in a laboratory, clinical, or regulatory documentation setting
- Knowledge of long-term data retention and archival best practices
- Familiarity with electronic archiving systems and metadata management
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.
