Scientific Program Manager & Biologics SME

Scientific Program Manager & Biologics SME (Subject Matter Expert)

Fulltime

Exton, PA

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

The Scientific Program Manager & Biologics SME will serve as the primary scientific liaison for large molecule bioanalytical programs, including PK, immunogenicity (ADA), cell-based and non-cell-based neutralizing antibody (NAb) assays, and other complex ligand-binding and cell-based assay platforms.

This role combines scientific expertise and client-facing communication to drive successful execution of GLP, non-GLP, and clinical support studies within the Biologics Service group.

The position works closely with laboratory operations, quality assurance, program management, and business development teams to ensure technical excellence, regulatory compliance, and efficient delivery of high-quality data to sponsors.

Key Responsibilities:

Scientific Liaison & SME Support:

• 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.

Program Management & Client Engagement:

• 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.

Regulatory & Quality Compliance:

• 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.

Qualifications:

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.

Competencies

• Strong scientific communication and presentation skills.
• Ability to lead projects cross-functionally and coordinate with operations, PM, BD, and QA.
• Strategic problem-solving mindset with attention to detail.
• Client-focused, collaborative, and able to operate in a fast-paced CRO environment.

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.