Frontage
Scientist/Senior Scientist - Cell Bioassay/Potency
Frontage, Exton, Pennsylvania, United States, 19341
If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.Scientist/Senior Scientist - Cell Bioassay/Potency
Full Time | Exton, PA, US2 days ago | Requisition ID: 1495Title:
Scientist/Sr. Scientist, Cell Bioassay/PotencyReports to:
Sr Director BGC Therapy OperationsCompany Overview:
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:The Scientist/Sr. Scientist will be a leading member of the Analytical Technologies group responsible for bioassay development, validation, transfer, and execution. The bioassays include cell-based potency assays, ELISA, PCR-based assays, and virus infectivity assays used to support product characterization, release, stability studies in GMP settings, and other research projects for process, formulation, and manufacturing development. This position will contribute to the strategy of selecting and implementing bioassays to ensure our products are comprehensively characterized and under superb quality control. The role may involve leading a small group to achieve department goals.Develop and apply molecular biological methods, immunoassays, and other state-of-the-art analytical technologies to analyze and characterize cell and gene products, biotherapeutic proteins, their conjugates, and variants.Independently select, develop, validate, and transfer biological assays including cell-based potency assays, ELISA, qPCR-based assays, and virus infectivity assays.Perform method development, validation, tech transfer, product characterization, impurity profiling, routine, and stability testing across various biological products.Prepare project proposals, protocols, reports, Certificate of Analysis, investigation reports, and generate cGMP documents.Prepare and review notebooks in compliance with Frontage CMC SOPs.Maintain qualification and compliance of instruments and conduct technical and instrumental troubleshooting.Manage projects from initiation to completion, ensuring they are on time and meet pre-established quality standards.Author method SOPs, development reports, and qualification/validation reports to support method transfer to GMP QC.Perform analytical tests to support method development, DS/DP characterization, PD studies, lot release, and stability testing of drug substances and drug products.Develop and optimize analytical methods in accordance with client requirements and associated protocols and procedures.Education, Experience & Skills Required:Educational/Training Requirement:PhD, MS, or BS in Biological Science, Biochemical Engineering, or a related discipline.Experience:PhD in Biological Science, Biochemical Engineering, or a related discipline with 0-2 years of relevant industrial GMP testing or analytical development experience for biologics or cell and gene therapy products; orMS with 2-4 years of GMP testing or analytical development experience for biologics or cell and gene therapy products; orBS with 3-5 years of GMP testing or analytical development experience for biologics or cell and gene therapy products.Excellent organization and planning skills.Experience in virus-vector based biotechnology or virology in general is preferred but not required.Excellent communication skills, with the ability to work with individuals in wide-ranging teams at all levels and the ability to lead and influence.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 a disability.
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Full Time | Exton, PA, US2 days ago | Requisition ID: 1495Title:
Scientist/Sr. Scientist, Cell Bioassay/PotencyReports to:
Sr Director BGC Therapy OperationsCompany Overview:
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:The Scientist/Sr. Scientist will be a leading member of the Analytical Technologies group responsible for bioassay development, validation, transfer, and execution. The bioassays include cell-based potency assays, ELISA, PCR-based assays, and virus infectivity assays used to support product characterization, release, stability studies in GMP settings, and other research projects for process, formulation, and manufacturing development. This position will contribute to the strategy of selecting and implementing bioassays to ensure our products are comprehensively characterized and under superb quality control. The role may involve leading a small group to achieve department goals.Develop and apply molecular biological methods, immunoassays, and other state-of-the-art analytical technologies to analyze and characterize cell and gene products, biotherapeutic proteins, their conjugates, and variants.Independently select, develop, validate, and transfer biological assays including cell-based potency assays, ELISA, qPCR-based assays, and virus infectivity assays.Perform method development, validation, tech transfer, product characterization, impurity profiling, routine, and stability testing across various biological products.Prepare project proposals, protocols, reports, Certificate of Analysis, investigation reports, and generate cGMP documents.Prepare and review notebooks in compliance with Frontage CMC SOPs.Maintain qualification and compliance of instruments and conduct technical and instrumental troubleshooting.Manage projects from initiation to completion, ensuring they are on time and meet pre-established quality standards.Author method SOPs, development reports, and qualification/validation reports to support method transfer to GMP QC.Perform analytical tests to support method development, DS/DP characterization, PD studies, lot release, and stability testing of drug substances and drug products.Develop and optimize analytical methods in accordance with client requirements and associated protocols and procedures.Education, Experience & Skills Required:Educational/Training Requirement:PhD, MS, or BS in Biological Science, Biochemical Engineering, or a related discipline.Experience:PhD in Biological Science, Biochemical Engineering, or a related discipline with 0-2 years of relevant industrial GMP testing or analytical development experience for biologics or cell and gene therapy products; orMS with 2-4 years of GMP testing or analytical development experience for biologics or cell and gene therapy products; orBS with 3-5 years of GMP testing or analytical development experience for biologics or cell and gene therapy products.Excellent organization and planning skills.Experience in virus-vector based biotechnology or virology in general is preferred but not required.Excellent communication skills, with the ability to work with individuals in wide-ranging teams at all levels and the ability to lead and influence.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 a disability.
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