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Scientific Program Manager & Biologics SME

0fad767f F389 40ea B2d1 D8df05098476 19000101 000001 · Exton, PA, US, Exton, PA · Active · ADP Workforce Now Recruiting

Job facts

FieldValue
Company0fad767f F389 40ea B2d1 D8df05098476 19000101 000001
TitleScientific Program Manager & Biologics SME
Normalized title-
Department / team-
LocationExton, PA, United States
Work model-
Employment typeFull Time
Salary-
Statusactive
ATS providerADP Workforce Now Recruiting
Posted / first seen2025-11-24 / 2026-05-31
Changed / last seen2026-06-23 / 2026-06-23

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Linked records

Company0fad767f F389 40ea B2d1 D8df05098476 19000101 000001
Source57b990c1-73e8-474a-b966-75ea19495511
ATS providerADP Workforce Now Recruiting

Description

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.

Full job record

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TitleScientific Program Manager & Biologics SME
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First Seen At2026-05-31 18:30:14Z
Last Seen At2026-06-23 13:07:14Z
Last Checked At2026-06-23 13:07:14Z
Last Changed At2026-06-23 13:07:14Z
Inactive At—
Source Posted At2025-11-24 20:02:00Z
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font-family: \"arial narrow\", sans-serif; color: black;'>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. &nbsp;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.</span><span style='color: black; font-family: \"arial narrow\", sans-serif;'>&nbsp;</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: 'arial narrow',sans-serif;\"><strong>Position Summary</strong></span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: 'arial narrow',sans-serif;\">The Scientific Program Manager &amp; 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.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: 'arial narrow',sans-serif;\">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.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: 'arial narrow',sans-serif;\">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.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: 'arial narrow',sans-serif;\"><strong>Key Responsibilities:</strong></span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: 'arial narrow',sans-serif;\"><strong>Scientific Liaison &amp; SME Support:</strong></span></p><div style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;\"><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Present and introduce Biologics services to clients, including LBA-based assays for PK, ADA, NAb, and cell-based functional assays.</li><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Provide scientific consultation during pre-clinical and clinical program design, including assay selection, format, feasibility, and method development strategy.</li><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Serve as subject matter expert on large molecule assay performance, MRD, analytical range, cut-point strategy, validation parameters, and sample analysis workflow.</li></ul></div><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: 'arial narrow',sans-serif;\">&nbsp;</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: 'arial narrow',sans-serif;\"><strong>Program Management &amp; Client Engagement:</strong></span></p><div style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;\"><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Act as scientific point-of-contact for assigned programs; attend kickoff, alignment, troubleshooting, and result review meetings.</li><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Coordinate with Program Management to ensure timelines, deliverables, and sponsor expectations are clearly communicated and met.</li><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Prepare or review scientific sections of proposals, protocols, validation plans, and study reports.</li><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Collaborate with lab supervisors and technical teams to troubleshoot assay challenges and implement scientific improvements.</li></ul></div><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: 'arial narrow',sans-serif;\"><strong>Regulatory &amp; Quality Compliance:</strong></span></p><div style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;\"><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Familiar with appropriate regulatory frameworks, including FDA 21 CFR Part 58 (GLP)</li><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Non-GLP discovery and early development programs.</li><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Clinical sample testing requirements (GCP interface).</li><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Partner with QA and Compliance on audits, data integrity requirements, documentation accuracy, and deviation investigations.</li></ul></div><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: 'arial narrow',sans-serif;\"><strong>Qualifications:</strong></span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: 'arial narrow',sans-serif;\"><strong>Required</strong></span></p><div style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;\"><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Master&rsquo;s degree or higher in Biology, Biochemistry, Pharmaceutical Sciences, Immunology, or related field (PhD preferred but not required).</li><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>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.</li><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Other functional / MOA-based cell assays.</li><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Demonstrated knowledge of GLP regulations (21 CFR Part 58) and experience supporting non-GLP and clinical programs.</li><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Strong ability to interpret complex scientific data and communicate clearly with internal teams and external sponsors.</li><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Experience working in a CRO or regulated bioanalytical environment strongly preferred.</li></ul></div><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: 'arial narrow',sans-serif;\"><strong>Preferred</strong></span></p><div style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;\"><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Experience in a leadership or supervisory role.</li><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Familiarity with BioA reporting structures, immunogenicity risk assessments, and cut-point strategies.</li><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Experience interacting with regulatory agencies or contributing to submissions.</li></ul></div><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: 'arial narrow',sans-serif;\"><strong>Competencies</strong></span></p><div style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;\"><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Strong scientific communication and presentation skills.</li><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Ability to lead projects cross-functionally and coordinate with operations, PM, BD, and QA.</li><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Strategic problem-solving mindset with attention to detail.</li><li style='margin: 0in 0in 8pt; line-height: 115%; font-size: 16px; font-family: \"arial narrow\", sans-serif;'>Client-focused, collaborative, and able to operate in a fast-paced CRO environment.</li></ul></div><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: 'arial narrow',sans-serif;\"><strong>Salary and Benefits:</strong></span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:7.5pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;background:white;'><span style='color: black; font-family: \"arial narrow\", sans-serif;'>Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:7.5pt;margin-left:0in;line-height:normal;font-size:16px;font-family:\"Aptos\",sans-serif;background:white;'><em><span style='font-family: \"arial narrow\", sans-serif; color: rgb(65, 65, 65);'>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.</span></em></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'>&nbsp;</p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'>&nbsp;</p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'>&nbsp;</p>\n",
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