Senior Scientist, Analytical Ultracentrifuge, BGCT Operations

Title: Senior Scientist

Location: Exton PA

Reports to: Sr Director, BGC Therapy Operations

Full-time

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 will support the development, validation, and transfer of Analytical ultracentrifugation, chromatography, and separations sciences methods in support of cell and gene therapy product development and analytical testing. The successful candidate will perform sample preparation, testing, methods development, and characterization particularly for the assessment of the molecular weight of size variants by either SEC-MALS (HPLC coupled with light scattering detection) or AUC (analytical ultracentrifugation) for Viral products. The role will support other higher order structures by spectroscopic techniques such as FTIR, Circular dichroism (CD) or Differential Scan calorimeter (DSC).

The Scientist will serve as a subject matter expert in analysis of virus products using Analytical ultracentrifugation.

Roles & Responsibilities:

• The successful candidate will perform sample preparation, testing, methods development, and characterization particularly for the assessment of the molecular weight of size variants by either SEC-MALS (HPLC coupled with light scattering detection) or AUC (analytical ultracentrifugation) for biopharmaceutical products.
• The role day to day responsibilities will include the characterizing of higher order structure by spectroscopic techniques such as FTIR, Circular dichroism or DSC.
• The overall objective will be to support comparability and similarity studies, technology development efforts, and non-routine investigations for biophysical techniques.
• Duties will include sample preparation, complex data analyses, generation of technical documents and technical presentations, and setting of acceptance criteria in support of process development, process/method transfers, and comparability/stability studies.
• The position will require the ability to work collaboratively with other scientists, and to have the capacity to be flexible and adaptive to changing priorities.
• The role will support the characterization of gene therapy products based on different serotypes at various stages of the development and manufacturing process.
• Maintain and provide routine characterization using AUC for Empty/Full capsids ratio measurement.
• Provide instrument maintenance support and instrument documentation.

Education, Experience & Skills Required:

• M.S degree in Chemistry, Biochemistry, Biotechnology, Physics or related discipline, Or B.S. degree in Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Physics, or related discipline with 3+ years’ work experience in the biopharmaceutical industry.
• Proven expertise in AUC, macromolecular characterization, and related technologies.
• Exposure to Optima AUC Analytical Ultracentrifuge instrument and skills to interpret data and draw preliminary conclusions using Ultra Scan, SEDFIT is major plus.
• Proven leadership, organizational and management skills to coordinate cross functional decision making with department leadership.
• Ability to comprehend technical information related to analytical methods, processes, and regulatory expectations.
• Expertise in potency assay development, transfer, and qualification for protein therapeutics or cell and gene therapy areas for early phase to late phase programs. Commercial experience is a plus.
• Experience drafting protocols and technical reports and authoring regulatory filings and responses.
• Strong experience cGMP as well as assay development and validation are required.
• Experience working in a matrix team across disciplines and departmental lines, and experience working in a global and multicultural organization.

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.