Frontage Laboratories, Inc · 1 month ago
Scientific Program Manager & Biologics SME
Exton, PA, US
Full-time
Onsite
Senior Level
5+ years expFrontage Laboratories Inc. is an award-winning, full-service CRO operating over 25 laboratories across the US, Canada, and China. The Scientific Program Manager & Biologics SME will serve as the primary scientific liaison for large molecule bioanalytical programs, ensuring technical excellence and regulatory compliance while driving successful execution of studies within the Biologics Service group.
BiotechnologyClinical TrialsMedicalPharmaceuticalRobotics
Responsibilities
Present and introduce Biologics services to clients, including LBA-based assays for PK, ADA, NAb, and cell-based functional assays
Provide scientific consultation during pre-clinical and clinical program design, including assay selection, format, feasibility, and method development strategy
Serve as subject matter expert on large molecule assay performance, MRD, analytical range, cut-point strategy, validation parameters, and sample analysis workflow
Act as scientific point-of-contact for assigned programs; attend kickoff, alignment, troubleshooting, and result review meetings
Coordinate with Program Management to ensure timelines, deliverables, and sponsor expectations are clearly communicated and met
Prepare or review scientific sections of proposals, protocols, validation plans, and study reports
Collaborate with lab supervisors and technical teams to troubleshoot assay challenges and implement scientific improvements
Familiar with appropriate regulatory frameworks, including FDA 21 CFR Part 58 (GLP)
Non-GLP discovery and early development programs
Clinical sample testing requirements (GCP interface)
Partner with QA and Compliance on audits, data integrity requirements, documentation accuracy, and deviation investigations
Qualification
Required
Master's degree or higher in Biology, Biochemistry, Pharmaceutical Sciences, Immunology, or related field (PhD preferred but not required)
5+ years of hands-on experience developing, validating, and troubleshooting large molecule assays, including PK (ligand-binding assays), ADA (screening, confirmatory, titration). Cell-based NAb assays
Other functional / MOA-based cell assays
Demonstrated knowledge of GLP regulations (21 CFR Part 58) and experience supporting non-GLP and clinical programs
Strong ability to interpret complex scientific data and communicate clearly with internal teams and external sponsors
Experience working in a CRO or regulated bioanalytical environment strongly preferred
Preferred
Experience in a leadership or supervisory role
Familiarity with BioA reporting structures, immunogenicity risk assessments, and cut-point strategies
Experience interacting with regulatory agencies or contributing to submissions
Benefits
Health and dental insurance
A 401(k) plan
Disability insurance
Life insurance
Company
Frontage Laboratories, Inc
Frontage Laboratories is a US-based Contract Research Organization (CRO) that was initially established in New Jersey in April 2001 and later relocated to Pennsylvania in 2004.
1001-5000 employees
H1B Sponsorship
Frontage Laboratories, Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (38)
2024 (37)
2023 (24)
2022 (29)
2021 (34)
2020 (45)
Funding
Current Stage
Public CompanyTotal Funding
$42.37MKey Investors
Baird Capital
2019-05-30IPO
2018-03-01Undisclosed· $32.37M
2014-05-08Acquired
Leadership Team
Song Li
CEO
Abdul Mutlib
Vice President
Recent News
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